Latest Industry News & Trends
Market Scope provides comprehensive coverage of the ophthalmic market. Our news stories are a combination of public and proprietary content ranging from coverage of international meetings, surgeon survey results and trends, analysis of company financial reports and public medical registries, press releases, and interviews with executives. Register today to receive free weekly email updates, our top data chart, surgeon poll results, and much more. Locked content can be accessed through a subscription to our ophthalmic industry newsletters.
Breaking News
Oertli Launches OS 4 Up Dual-Function Cataract-Vitrectomy System
Switzerland-based Oertli announced Feb. 23 that its OS 4 Up dual-function cataract/vitrectomy machine is now available in all CE-certified markets. Features include adaptive energy delivery with Ph...
Ophthalmic Quarterly and 2025 Revenue for Carl Zeiss Meditec, Harrow, RxSight, ANI, and Xbrane
Million Carl Zeiss Meditec reported Feb. 12 that ophthalmology revenue for the last three months of 2025, the first quarter of its fiscal year 2025/2026, totaled €356.9 million ($419.2 million, con...
Rayner Acquires Distribution Rights to Anikavisc OVD in US
UK-based Rayner reported March 2 that it had acquired the US distribution rights to Anikavisc, an ophthalmic viscosurgical device (OVD), from Japan’s Visco Technologies Inc. Anikavisc, a cohesive f...
US FDA Gives Green Light to Phase III Trial of Harrow’s Triesence for Post-op Inflammation and Pain
Nashville, Tennessee-based Harrow reported on March 3 that the US FDA had signed off on its investigational new drug (IND) application, allowing the company to proceed with a Phase III trial of Tri...
Alcon-Lensar Deal Now Expected to Close in First Half of 2026
Alcon’s acquisition of Lensar is now on track to close in the first half of 2026, subject to customary conditions, including receipt of regulatory approval from the US Federal Trade Commission, Len...
US FDA Gives Green Light to Phase I/II Trial of Sanaregen’s Retinal Cell Therapy Candidate
Sanaregen Vision Therapeutics reported March 3 that the US FDA had signed off on its investigational new drug (IND) application, allowing the company to proceed with a Phase I/II trial of its retin...
Sandoz Reports EU Approval for Ranibizumab Biosimilar Branded Ranluspec
Swiss drugmaker Sandoz announced Feb. 23 that the European Commission had granted marketing authorization for Ranluspec, a ranibizumab biosimilar developed by India’s Lupin Limited. Sandoz holds ex...
Cirrus Expands to Singapore, Unveils GA Cell Therapy Candidate
Cirrus Therapeutics reported March 3 that it had established an R&D site in Singapore, expanding its presence in the Asia-Pacific region. The Cambridge, Massachusetts, company also unveiled a secon...
Axol Bioscience Acquires Ophthalmology Business from Newcells Biotech
UK-based Axol Bioscience, a provider of induced pluripotent stem cell (iPSC) technologies for drug discovery and research, reported Feb. 18 that it had acquired the ophthalmology business of Newcel...
EyeMD Electronic Health Records Platform Rebrands as Optivate
EyeMD EMR Healthcare Systems and its billing subsidiary Abillifeye announced March 3 that they would rebrand as Optivate and launch a new website, optivatehealth.com. Optivate, of Bonita Springs, F...
US FDA Accepts sNDA for Opus’ Presbyopia Candidate, Sets PDUFA Date of Oct. 17, 2026
Commercial partners Viatris and Opus Genetics reported Feb. 25 that the US FDA had accepted the supplemental new drug application (sNDA) for MR-141 (phentolamine ophthalmic solution 0.75%), targeti...
2025 Ophthalmic Revenue Roundup for Alcon, Apellis, Tarsus, and Immunocore
Alcon reported Feb. 24 that its full year 2025 net sales totaled $10.3 billion, a 5 percent increase over $9.8 billion in 2024. Q4-2025 sales were $2.7 billion, a 9 percent increase over $2.5 billi...
Children’s Hospital Los Angeles Pioneers Aqueous Biopsy Test for Ocular Cancer
Researchers at Children’s Hospital Los Angeles (CHLA) have developed a liquid biopsy test of aqueous humor that they say can significantly improve the diagnosis and clinical management of tumors in...
Outlook Grants Mediconsult Rights to Market Lytenava in Switzerland
Outlook Therapeutics announced Feb. 19 an agreement granting Mediconsult exclusive commercial distribution rights for Lytenava (bevacizumab gamma) in the Swiss market. Financial details were not di...
HelpMeSee Launches Simulation-Based MSICS Training Centers in Ghana, Nigeria
Global nonprofit group HelpMeSee announced in February that it had opened new virtual training centers for manual small incision cataract surgery (MSICS) in Ghana and Nigeria. Both training centers...
Formosa Licenses Clobetasol Drops to Arrotex for Australia, New Zealand
Taiwan-based Formosa Pharmaceuticals announced Feb. 23 that it had agreed to license to Arrotex Pharmaceuticals exclusive rights to market clobetasol propionate 0.05% eye drops for postsurgical inf...
US FDA Gives Green Light to Phase II/III Trial of NexEos Bio’s Vernal Keratoconjunctivitis Candidate
NexEos Bio reported on Feb. 19 that the US FDA had signed off on its investigational new drug (IND) application, allowing the company to proceed with a Phase II/III trial of NTX-1024, a topical can...
US FDA Gives Green Light to Phase II Trial of Cloudbreak’s Presbyopia Drop Candidate
The financial website TipRanks reported on Feb. 15 that the US FDA had signed off on Cloudbreak Pharma’s investigational new drug (IND) application, allowing the company to proceed with a Phase II ...
2026-2027 Ophthalmic Meetings Calendar
Market Scope regularly updates its list of ophthalmic meetings to keep the information current. Please contact us at matthewdouty@market-scope.com if we do not have your meeting listed. Thank you.
US FDA Will Drop Two-Study Requirement for New Drug Approvals
The US FDA plans to drop its longtime standard of requiring two rigorous studies to win approval for new drugs, according to a journal article published Feb. 18. Going forward, the agency’s “defaul...
2025 Ophthalmic Revenue Roundup for Bausch + Lomb and Glaukos
Bausch + Lomb reported Feb. 18 that its 2025 revenue totaled $5.1 billion, a 6 percent increase over $4.8 billion in 2024. The company’s Q4-2025 revenue was $1.4 billion, a 10 percent increase over...
US FDA Expands Indication for STAAR’s Evo ICL to Patients Up to Age 60
STAAR Surgical announced Feb. 17 that the US FDA had approved an expanded age indication for Evo and Evo+ implantable Collamer lenses (ICLs), extending their use from patients 21 to 45 years old to...
Ocular Therapeutix Reports Positive Results for Axpaxli vs. Eylea in Phase III Wet AMD Trial
Ocular Therapeutix reported on Feb. 17 positive topline results in the SOL-1 Phase III superiority trial of Axpaxli vs. Eylea (aflibercept) in wet age-related macular degeneration (AMD). Axpaxli, a...
AOA Sounds Alert on Eyebot Vision Kiosks, Calls for Greater Oversight
The American Optometric Association (AOA) is sounding an alert on Eyebot kiosks, where consumers can get 90-second vision tests and doctor-reviewed eyeglass prescriptions. Through a partnership wit...
Eye PCR Gains CE Marking for FixOflex Endocapsular Device
Eye PCR announced Feb. 13 that its FixOflex endocapsular device had gained CE marking under the European Union Medical Device Regulation, clearing the way for a “controlled market introduction.” Th...
Private Equity Firm Sells Maker of RetEval ERG Device to Ametek
The private equity firm DW Healthcare Partners announced Feb. 3 that it had sold LKC Technologies, maker of the RetEval electroretinogram device, to the global electronic instrument manufacturer Am...
Okyo Pharma Appoints Flavio Mantelli, MD, PhD, as Chief Medical Officer
London’s Okyo Pharma announced Feb. 10 that it had appointed Flavio Mantelli, MD, PhD, as chief medical officer. Mantelli most recently served as chief medical officer of Dompé, where he led the cl...
Belgian Company Invests 500 Million Euros for 45 Percent Stake in Rayner
Belgian investment company Groupe Bruxelles Lambert (GBL) reported Feb. 9 that it would invest 500 million euros (US $594 million, calculated on Feb. 11, 2026) in UK-based ophthalmic company Rayner...
2025 and Quarterly Ophthalmic Revenue Roundup for Amgen, Santen, Hoya, Lumibird, and Ocular Therapeutix
Amgen, of Thousand Oaks, California, reported Feb. 3 that its 2025 revenue for Tepezza was $1.90 billion, a 3 percent increase over $1.85 billion in 2024, primarily driven by higher net selling pri...
New US Law Institutes Major Pharmacy Benefit Manager Reforms in 2029
The $1.2 trillion US spending package signed into law on Feb. 3 includes major reforms to pharmacy benefit manager (PBM) practices. These provisions go into effect for health plan years that come a...
Samsung Bioepis’ Deals with Regeneron Clear Way for Eylea Biosimilar in US, Other Markets
Samsung Bioepis reported Feb. 12 that it had reached a settlement and license agreement with Regeneron that will allow its biosimilar to Eylea, branded Opuviz, to be launched in the US in January 2...
Nordic Pharma Launches Lacrifill Canalicular Gel for Dry Eye in Europe
Dutch drugmaker Nordic Pharma announced Feb. 5 the European launch of Lacrifill canalicular gel for dry eye. The treatment gained CE marking in April 2025. Lacrifill is a cross-linked hyaluronic ac...
American College of Eye Technicians Offers Fast-Track Virtual Training Program
The American College of Eye Technicians (ACET) recently opened enrollment for its fast-track virtual training program, an eight-week session that combines interactive activities and coursework to p...
MeiraGTx Licenses ZipBio’s Protein Therapeutic Technology for GA
MeiraGTx has obtained exclusive rights to protein therapeutic technology for geographic atrophy (GA) from ZipBio, the companies announced Feb. 3. The agreement includes an upfront payment, as well ...
Arctic Vision to Acquire MDCO Technology’s Ophthalmic Device Business
China’s Arctic Vision announced Feb. 2 that it would acquire the ophthalmic device business of MDCO Technology. Arctic Vision said MDCO markets a premium intraocular lens (IOL), a phakic lens, and ...
Alvotech’s Deal with Regeneron, Bayer Clears Way for Eylea Biosimilar in Multiple Markets
Alvotech, of Reykjavik, Iceland, reported Jan. 29 that it had reached a settlement and license agreement with Regeneron and Bayer that resolves all remaining patent disputes worldwide for its biosi...
Quarterly and 2025 Ophthalmic Revenue Roundup for Roche, Regeneron, AbbVie, Novartis, and Astellas
Swiss company Roche reported Jan. 29 that global sales of Vabysmo for 2025 were CHF 4.1 billion ($5.2 billion, converted Dec. 25, 2025), a 6 percent increase on a reported basis (+12 percent cc) ov...
Sandoz Launches Aflibercept Biosimilar Enzeevu in Canada
Swiss drugmaker Sandoz announced Feb. 2 that it had launched its Eylea biosimilar, branded Enzeevu, in Canada. Enzeevu (aflibercept-abzv) gained approval in Canada in October 2025 for all the refer...
STAAR Names Warren Foust and Deborah Andrews as Interim Co-CEOs Amid Search for Permanent Leader
STAAR Surgical, of Lake Forest, California, reported Feb. 2 that it had appointed Warren Foust and Deborah Andrews as interim co-CEOs, while the company conducts a global search for a permanent CEO...
Harrow Ends Compounded Product Sales in California, Plans to Sell All Products Under Harrow Label
Harrow reported Feb. 2 that it had stopped selling compounded products in California through its ImprimisRx subsidiary on Feb. 1, after settling a disciplinary action brought by the California Boar...
US FDA Gives Green Light to Trial of Life Bio’s Cell Rejuvenation Candidate in Optic Neuropathies
Life Biosciences reported on Jan. 28 that the US FDA had signed off on its investigational new drug (IND) application, allowing the company to proceed with a Phase I trial of ER-100, a cell rejuven...
Santen Gains Approval in Japan for RVL’s Blepharoptosis Drops Under Name Upneeq Mini
RVL Pharmaceuticals announced Jan. 8 that its partner Santen had gained manufacturing and marketing approval in Japan for RVL’s eye drop formulation of oxymetazoline hydrochloride, to be known in J...
Opus Launches Trial in Abu Dhabi for RP Gene Therapy Candidate
Opus Genetics announced Jan. 27 that it had launched a clinical trial in Abu Dhabi, the capital of the United Arab Emirates, for its gene therapy candidate targeting MERTK-related retinitis pigment...
Merged Southeastern US Eye Banks Will Be Known as Precision Ocular Network
Two Southeastern US eye banks, Advancing Sight Network and Miracles In Sight, announced Jan. 27 that their merged operations would be known as Precision Ocular Network. The organizations announced ...
US FDA Grants Orphan Drug Status to BlueRock’s RP Cell Therapy Candidate
Bayer subsidiary BlueRock Therapeutics announced Jan. 22 that the US FDA had granted orphan drug status to OpCT-001, its cell therapy candidate for retinitis pigmentosa (RP). Orphan drug designatio...
US FDA Grants Fast Track Status to Drug Farm’s ROSAH Candidate
Drug Farm, of Shanghai, China, announced Jan. 27 that the US FDA had granted fast track designation to DF-003, an oral alpha kinase 1 (ALPK1) inhibitor targeting the rare genetic disease ROSAH synd...
Orbis International Appoints Kathleen Sherwin, MBA, as President and CEO
Orbis International announced Jan. 12 that it had appointed Kathleen Sherwin as president and chief executive officer. New York-based Orbis said Sherwin brings more than 25 years of experience adva...
US FDA Approves Re-administration of Glaukos’ iDose TR
Glaukos announced Jan. 28 that the US FDA had approved a supplement to its new drug application allowing for re-administration of iDose TR, the company’s intracameral travoprost implant for glaucom...
US FDA Approves Tenpoint’s Yuvezzi Drops for Presbyopia
Tenpoint Therapeutics announced Jan. 28 that the US FDA had approved Yuvezzi (carbachol and brimonidine tartrate ophthalmic solution 2.75%/0.1%) for presbyopia. The company said it expects to launc...
EU-India Free Trade Agreement to Phase in Lower Pharma and Device Tariffs
A free trade agreement reached Jan. 27 by the European Union and India will reduce or eliminate tariffs on about 90 percent of goods, including pharmaceuticals and medical devices, between the two ...
US FDA Rolls Out PreCheck Program to Speed Approval of Drug Manufacturing Plants
The US FDA announced Jan. 21 that it would begin accepting applications on Feb. 1, 2026, for its new PreCheck Pilot Program to improve the regulatory process for US manufacturing facilities. The ag...
Nidek Launches the Phantom Open-Field Refraction System
Japanese company Nidek reported Jan. 26 that it had launched the Phantom Open-Field Refractive System. An open-field system eliminates the traditional phoropter in front of the patient; instead, vi...
US FDA Gives Green Light to Phase II Trial of Novaliq’s Topical Uveitis Candidate
Germany’s Novaliq reported on Jan. 26 that the US FDA had signed off on its investigational new drug (IND) application, allowing the company to proceed with a Phase II trial of NOV05, its topical, ...
US FDA Authorizes Compassionate Use of Urcosimod for Neuropathic Corneal Pain
London’s Okyo Pharma announced Jan. 23 that the US FDA had authorized a compassionate-use request for a single patient with severe neuropathic corneal pain to be treated with urcosimod (0.05%). The...
Emmecell Appoints Ramin Valian as Chief Executive Officer
Emmecell announced Jan. 16 that it had appointed ophthalmic industry veteran Ramin Valian as chief executive officer. Valian spent more than 20 years in top roles at Allergan and AbbVie, where he d...
J&J Vision Reports 2025 Surgical Vision Revenue of $1.6 Billion
Johnson & Johnson reported Jan. 21 that its full year 2025 global surgical vision revenue was $1.6 billion, a 10.2 percent increase over $1.4 billion in 2024. Revenue was up 6.1 percent in the US a...
Rayner Launches Sophi Phaco Machine in the US
UK-based Rayner reported Jan. 14 that it was launching its Sophi phacoemulsification system in the US. The unit, whose name is short for Swiss ophthalmology innovation, was developed by Swiss firm ...
Eylea 8 mg Gains EU Approval to Treat Macular Edema Following RVO
German drugmaker Bayer announced Jan. 16 that the European Commission had approved Eylea 8 mg, known as Eylea HD in the US, to treat patients with visual impairment due to macular edema following r...
BioAge Enters Ophthalmology with Oral NLRP3 Inhibitor Candidate for DME
BioAge Labs announced Jan. 20 that it would expand development of BGE-102, an orally administered NLRP3 inhibitor, into ophthalmology with a proof-of-concept study in diabetic macular edema (DME). ...
BioTissue Sells Non-ophthalmic Surgical and Wound Care Business to BioStem
BioTissue Holdings reported Jan. 21 that it had sold its non-ocular surgical and wound care business to BioStem Technologies for an upfront cash payment of about $15 million, plus potential milesto...
Nanoscope’s MCO-010 Gains Sakigake (Pioneer) and Orphan Drug Status in Japan
Nanoscope Therapeutics announced Jan. 20 that Japan’s Ministry of Health, Labour, and Welfare had granted Sakigake (Pioneer) and orphan drug designations to MCO-010 across inherited retinal disease...
BVI Medical Appoints Jim Hollingshead, PhD, as President and CEO
BVI Medical announced Jan. 19 that it had appointed Jim Hollingshead, PhD, as president and chief executive officer. Hollingshead succeeds Shervin Korangy, who will continue to serve as an advisor ...
STAAR Agrees to Leadership Changes Following Failed Acquisition Attempt
STAAR Surgical and Broadwood Partners reported Jan. 15 that STAAR had agreed to several leadership changes, as the phakic IOL maker moves forward from a shareholder revolt that ended Alcon’s attemp...
Formosa Licenses Clobetasol Drops to Samil for South Korea
Taiwan-based Formosa Pharmaceuticals announced Jan. 12 that it had agreed to license to Samil Pharmaceuticals exclusive rights to market clobetasol propionate 0.05% eye drops for postsurgical infla...
Topcon Healthcare Partners with RemoniHealth for Remote Eye Screening
Topcon Healthcare announced Jan. 13 a commercial partnership with RemoniHealth, of White Plains, New York, which provides remote monitoring of eye disease. No financial details were disclosed. Remo...
US FDA Gives Green Light to Trial of Allotex’ Tissue Implant for Presbyopia
Allotex announced Jan. 8 that the US FDA had signed off on its investigational device exemption (IDE) submission, allowing the company to proceed with a trial of Allo-1, its tissue implant technolo...
Ikarovec Signs Option to License IVT Capsid Technology for Use with AMD Gene Therapy
UK-based Ikarovec reported Jan. 6 that it had signed an option agreement for a worldwide license of VectorBuilder’s novel capsid technology for use with IKAR-003, Ikarovec’s gene therapy candidate ...
Bio Usawa Gains Approval for Lucentis Biosimilar in Rwanda, Ghana
African biotech company Bio Usawa announced Jan. 13 that its Lucentis (ranibizumab) biosimilar had received marketing approval in Ghana under the brand name BioUcenta. The company said the approval...
GenSight Gains Compassionate Use Authorization for Lumevoq in France and Israel
GenSight Biologics reported in December 2025 that regulators in France and Israel had granted early access for compassionate use to Lumevoq, the company’s intravitreal gene therapy candidate for Le...
Nanodropper, Now Mu Medical, Plans Combination with Bedo and Viseon
Nanodropper, of Rochester, Minnesota, announced Jan. 9 that it was now operating as Mu Medical and planned to combine with Bedo Solutions and Viseon Labs under the new umbrella. Nanodropper was fou...
US FDA Grants Fast Track Status to Complement’s GA Gene Therapy Candidate
Complement Therapeutics announced Jan. 8 that the US FDA had granted fast track designation to CTx001, a gene therapy candidate targeting geographic atrophy (GA). Fast track status is intended to f...
STAAR Surgical Calls Off Alcon Acquisition Deal after Failed Shareholder Vote
STAAR Surgical reported Jan. 6 that it intended to terminate its acquisition agreement with Alcon, with no termination fee payable by either party. The announcement came minutes after the start of ...
US FDA Gives Green Light to Trial of GenEdit Bio’s Corneal Gene-Editing Candidate
GenEditBio reported on Jan. 5 that the US FDA had signed off on its investigational new drug (IND) application, allowing the company to proceed with a Phase I/II trial of GEB-101, its gene-editing ...
VivaVision Needs Single US Phase III Trial for Uveitis NDA, FDA Says
VivaVision Biotech reported Jan. 6 that minutes from its meeting with the US FDA confirm that its ongoing Phase III study in China can serve as one of the two pivotal trials required to support a U...
Christopher J. Rapuano, MD, to Use AAO Presidency to Focus on Emergency Eye Care
Christopher J. Rapuano, MD, plans to use his one-year term as president of the American Academy of Ophthalmology (AAO) to focus on improving emergency eye care services in hospital emergency rooms....
NEI Study Shows Gene Variants Don’t Always Lead to IRDs
New findings from researchers at Mass Eye and Ear challenge the traditional concept of certain gene mutations always resulting in vision loss. Instead, their work shows that genes thought to cause ...
Okyo Pharma Appoints Industry Veteran Robert J. Dempsey as CEO
London’s Okyo Pharma announced Jan. 5 that ophthalmic industry veteran Robert J. Dempsey would assume the role of chief executive officer. Gary S. Jacob, PhD, will transition to chief development o...
Lenz Signs Deal with Lunatus for Marketing of Vizz in Middle East
Lenz Therapeutics announced Jan. 5 an exclusive distribution agreement for Dubai’s Lunatus to develop and commercialize the presbyopia drop Vizz in the Middle East region. Under the deal, Lenz, of ...
US FDA Grants Breakthrough Status to Oculis’ Privosegtor for Optic Neuritis
Swiss company Oculis announced Jan. 6 that the US FDA had granted breakthrough therapy designation to Privosegtor, its treatment candidate for optic neuritis. Privosegtor is a peptoid small molecul...
US FDA Rejects Outlook’s Lytenava for a Third Time, Citing Lack of Efficacy Evidence
Outlook Therapeutics reported Dec. 31 that the US FDA had issued a third complete response letter rejecting the company’s biologics license application (BLA) for Lytenava, an ophthalmic formulation...
US FDA Approves Ranibizumab (Lucentis) Biosimilar from Bioeq, Formycon
Swiss company Bioeq announced Dec. 23 that the US FDA had approved its ranibizumab (Lucentis) biosimilar for all the reference product’s indications: wet age-related neovascular macular degeneratio...
US FDA Accepts Viridian’s TED Candidate for Priority Review, Sets PDUFA Date of June 30, 2026
Viridian Therapeutics reported Dec. 22 that the US FDA had accepted its biologics license application (BLA) for veligrotug, the company’s intravenous treatment candidate for thyroid eye disease (TE...
Alvotech, Teva Reach Deal with Regeneron to Bring Eylea Biosimilar to US Market No Later than H2-2026
Alvotech and Teva reported Dec. 19 that they had reached a settlement and license agreement with Regeneron that clears the way for Teva to commercialize AVT06, a biosimilar to Eylea, in the US, if ...
CMS Issues Billing Codes for Cellution’s Allograft, Balance’s Pressure Goggles
The US Centers for Medicare and Medicaid Services (CMS) issued a Q-code in Q3-2025 for Cellution Biologics’ AmchoMatrixDL, an amnion membrane allograft that acts as a barrier and provides protectiv...
US FDA Gives Green Light to Trial of Viatris’ Gene Therapy Candidate for NK
Viatris reported on Dec. 18 that the US FDA had signed off on its investigational new drug (IND) application, allowing the company to proceed with a Phase I/II trial of MR-146, a gene therapy candi...
Virtual Retina Could Help Unlock New Treatments for Vision Loss, Researchers Say
New computer modeling could help scientists better understand how the retina regenerates, opening the door to new treatments for vision loss, researchers from the UK’s University of Surrey say. The...
USC Roski Eye Takes Part in Phase IIb Trial of RPE Patch Candidate for GA
Researchers at the University of Southern California Roski Eye Institute reported Dec. 17 that they are taking part in a Phase IIb trial of Regenerative Patch Technologies’ retinal pigmented epithe...
Meibum Scientific Appoints Ryan S. Bleeks as Interim CEO
Meibum Scientific, of Brentwood, Tennessee, announced Dec. 2 that it had appointed Ryan S. Bleeks as interim chief executive officer to lead the commercialization of dry eye treatment devices Bleph...
Evoq Launches Twilight Dark Adaptometer in US
Evoq Technologies announced Nov. 24 that its Twilight dark adaptometer is registered and listed with the FDA as a Class I medical device and is now available for sale in the US. The company website...
Formycon, Klinge License Eylea Biosimilar to NTC for Italy
German companies Formycon and Klinge Biopharma announced Nov. 24 that they had reached a deal with Italian pharmaceutical company NTC to license their Eylea (aflibercept) biosimilar for Italy. The ...
EssilorLuxottica Acquires Signifeye Eye Centers in Belgium
EssilorLuxottica reported Dec. 12 that it had acquired Signifeye, a network of 15 eye centers and clinics in the Flanders region of Belgium. The transaction is expected to close by Q1-2026. No fina...
Argenx Pulls Plug on Thyroid Eye Disease Program on Recommendation of Data Monitors
Dutch drugmaker Argenx reported Dec. 15 that it would discontinue the Phase III program for subcutaneous efgartigimod in moderate to severe thyroid eye disease (TED). An independent data monitoring...
Health Canada Approves Celltrion’s Aflibercept Biosimilar Branded Eydenzelt
South Korea’s Celltrion announced Nov. 27 that Health Canada had approved Eydenzelt, an aflibercept (Eylea) biosimilar, in both vial and prefilled syringe formats. Eydenzelt (aflibercept-boav 40 mg...
Finland Researchers Study Heat’s Role in Slowing Progression of Dry AMD
Researchers at Aalto University in Finland announced Oct. 29 a promising approach to stopping the progression of dry age-related macular degeneration by using heat to trigger healing responses at t...
MIT Research Offers New Treatment Approach for Amblyopia
MIT researchers have demonstrated a new strategy for treating amblyopia in adults. The team showed that if the retina of the amblyopic eye is temporarily and reversibly anesthetized for a couple of...
Amneal Gains US FDA Approval for Generic Version of Restasis for Dry Eye
Amneal Pharmaceuticals announced Dec. 1 that it had received US FDA approval for its cyclosporine ophthalmic emulsion 0.05%, a sterile, preservative-free formulation supplied in single-use vials. C...
Alembic Gains US FDA Approval for Generic of Bausch + Lomb’s Zylet
India’s Alembic Pharmaceuticals announced Dec. 11 that the US FDA had approved the abbreviated new drug application for its combination eye drop of loteprednol etabonate and tobramycin, referencing...
Kiora Joins RARE-X Consortium Promoting Collaboration on Rare Ocular Disorders
Kiora Pharmaceuticals announced Oct. 30 that it had joined Global Genes’ RARE-X Vision Consortium, aiming to promote collaboration among advocacy, research, and industry stakeholders to fight rare ...
Alcon Exercises Right to Again Delay STAAR Shareholders’ Vote on Deal
STAAR Surgical reported Dec. 19 that its shareholder vote on Alcon’s acquisition of the phakic IOL maker had been delayed until Jan. 6, due to Alcon exercising its right to push back the vote under...
Ocular Therapeutix Takes Cue from US FDA, Will Submit NDA for Axpaxli After Single Phase III Trial
Ocular Therapeutix announced Dec. 8 that it planned to submit a new drug application (NDA) to the US FDA for Axpaxli in wet age-related macular degeneration (AMD) if it sees positive one-year data ...
Carl Zeiss Meditec Reports Annual Ophthalmic Revenue of $2 Billion
Carl Zeiss Meditec reported Dec. 11 that ophthalmology revenue for the company’s full fiscal year 2024/2025, which ended Sept. 30, was €1.7 billion (US $2.0 billion, converted on Sept. 30, 2025), a...
US FDA Extends Action Date on Aldeyra’s Reproxalap to March 2026
Aldeyra Therapeutics reported Dec. 15 that the US FDA had extended the Prescription Drug User Fee Act (PDUFA) target action date for dry eye drop candidate reproxalap to March 16, 2026. The new dru...
NTC Acquires Ophthalmology Business of Pharmathen
Italy-based NTC reported Dec. 10 that it had completed its acquisition of Pharmathen’s ophthalmology business. No financial details were provided. NTC’s main shareholder, Wise Equity, participated ...
French Regulators Give Green Light to Dose-Ranging Study of GenSight’s Lumevoq
France-based GenSight Biologics announced Dec. 2 that French regulators will allow the company to proceed with a dose-ranging study of Lumevoq, GenSight’s intravitreal gene therapy candidate for Le...
Prefilled Syringe of Byooviz Gains Positive CHMP Opinion
South Korea’s Samsung Bioepis announced Dec. 2 that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) had recommended approval of a prefilled syringe of its opht...
Alcon Raises Bid for STAAR Surgical; Large Shareholders Continue to Oppose Deal
Alcon reported Dec. 9 that it had amended its bid for phakic IOL maker STAAR Surgical, raising its offer to $30.75 per share in cash, up from $28 in August. The 9.8 increase did little to appease s...
CMS Finalizes 2.6 Percent Increase for ASCs, HOPDs in 2026
The Centers for Medicare and Medicaid Services (CMS) has finalized a 2.6 percent increase in fees for ASCs and HOPDs in 2026, the agency reported Nov. 21. The percentage represents an average acros...
US FDA Gives Green Light to Trial of EyeYon’s EndoArt Artificial Corneal Implant
Israel’s EyeYon Medical announced Dec. 8 that the US FDA had signed off on its investigational device exemption (IDE) submission, allowing the company to proceed with a trial of EndoArt, a syntheti...
Lenz Partner Lotus Pharmaceutical Submits NDA in Korea for Vizz Presbyopia Drop
Lenz Therapeutics announced Dec. 1 that its partner Lotus Pharmaceutical had submitted a new drug application (NDA) to South Korea’s Ministry of Food and Drug Safety seeking marketing approval for ...
Santen to Market Bayer’s Authorized Eylea Biosimilar in Japan After Drug Gains Coverage
Bayer’s authorized biosimilar of Eylea (aflibercept) has secured reimbursement in Japan, according to an announcement from commercial partner Santen on Dec. 5. Bayer received approval of the biosim...
US FDA Gives Green Light to Trial of Zhongmou’s Optogenetic Therapy for RP
China’s Zhongmou Therapeutics announced Nov. 27 that the US FDA had signed off on its investigational new drug (IND) application, allowing the company to proceed with a Phase I/II trial of ZM-02, t...
Alkeus Appoints Retina Specialist Carlos Quezada-Ruiz, MD, as Chief Medical Officer
Alkeus Pharmaceuticals announced Dec. 2 that it had appointed retina specialist Carlos Quezada-Ruiz, MD, as chief medical officer. He succeeds Seemi Khan, MD, MPH, MBA, who has taken the role of ch...
Kriya Appoints Greg Di Russo, MD, as Chief Medical Officer
Kriya Therapeutics announced Dec. 1 that it had appointed Greg Di Russo, MD, as chief medical officer. The Durham, North Carolina, company has a pipeline of gene therapy candidates for chronic cond...
Bausch + Lomb Outlines Growth Plans, Driven by Deep Pipeline
Bausch + Lomb used its investor day on Nov. 13 to lay out how it plans to produce growth of 6 to 8 percent in its surgical segment and 5 to 7 percent in its pharmaceutical, consumer, and contact le...
Iolyx Licenses Autoimmune Dry Eye Candidate to Théa in Deal Worth Up to $280 Million
Iolyx Therapeutics announced Dec. 3 that it had granted rights worldwide, excluding Asia, to France’s Laboratoires Théa to develop and commercialize ILYX-002, an immune-modulating eye drop candidat...
Formosa Licenses Clobetasol Drops to Rxilient for Countries in Southeast Asia
Taiwan-based Formosa Pharmaceuticals announced Dec. 3 that it had agreed to license to Rxilient Medical exclusive rights to market clobetasol propionate 0.05% eye drops for postsurgical inflammatio...
CDER Chief Pazdur Retiring from US FDA; Makary Names Høeg as Replacement
Oncologist Richard Pazdur, MD, is reportedly retiring from his role as the US FDA’s director of the Center for Drug Evaluation and Research (CDER) after less than a month in the job. The FDA announ...
Clearside to Pursue Strategic Sale Through Chapter 11 Process
Clearside Biomedical announced Nov. 24 that it had filed for Chapter 11 bankruptcy protection and intended to pursue an auction and sale of its business. Clearside, of Alpharetta, Georgia, had repo...
Ocuvex Resubmits NDA to US FDA for Once-Daily Brimonidine Drop
India’s Sun Pharma Advanced Research Company (SPARC) announced Nov. 20 that its partner Ocuvex had resubmitted the new drug application to the US FDA for PDP-716, a once-daily eye drop formulation ...
RVL Pharmaceuticals, Maker of Upneeq, Appoints Lori Deo as CEO
RVL Pharmaceuticals, of Bridgewater, New Jersey, announced Nov. 24 that it had appointed Lori Deo as chief executive officer. Deo had served as executive chairwoman of the board prior to the appoin...
Visara Appoints Cadmus Rich, MD, MBA, as Chief Medical Officer
NovaBridge Biosciences announced Nov. 20 that its ophthalmic subsidiary, Visara, had appointed ophthalmologist Cadmus Rich, MD, MBA, as its chief medical officer (CMO). Visara acquired VIS-101, for...
Cure Blindness Project’s 2025 Holiday Catalog Encourages Shoppers to Give Gift of Sight
Cure Blindness Project on Nov. 18 launched its 2025 Holiday Gift Guide, which the group describes as giving shoppers a thoughtful, sustainable, and hassle-free charity gift option. The catalog offe...
Bascom Palmer Eye Institute Opens Location in Abu Dhabi
The Bascom Palmer Eye Institute, part of the University of Miami Health System, announced that it was opening its first international location in Abu Dhabi, United Arab Emirates, in November. The p...
Assistance Fund Charity Launches Aid Program for MacTel Treatment
The Assistance Fund, a charitable organization that helps patients facing high out-of-pocket medical costs, announced Nov. 3 a new financial aid program for people living with macular telangiectasi...
Cartwheel to License ClearSight’s OTC Pink Eye Treatment
Cartwheel, of Boston, Massachusetts, reported Nov. 12 that it had signed a letter of intent to license ClearSight Therapeutics’ over-the-counter (OTC) pink eye treatment beginning in 2027. ClearSig...
Coave Unveils Lead Gene Therapy Program for Retinal Vascular Diseases
France’s Coave Therapeutics announced Nov. 14 the selection of its lead gene therapy program, CoTx-101, targeting retinal vascular diseases such as wet age-related macular degeneration and diabetic...
Curative Biotech Seeks Strategic Partner to Advance Metformin Eye Drops for AMD
Curative Biotechnology issued a letter to shareholders Nov. 18, outlining its plan to seek a strategic partner to advance the metformin-based eye drops it licensed from the National Eye Institute. ...
Xbrane Plans to Resubmit BLA to US FDA in March 2026 for Lucentis Biosimilar
Sweden’s Xbrane Biopharma announced Nov. 19 that it would resubmit the biologics license application (BLA) for its Lucentis (ranibizumab) biosimilar to the US FDA in March 2026. A complete response...
Precise Bio Treats First Patient With 3D Bioprinted Corneal Implant
Precise Bio announced Nov. 19 that the first patient had been treated with PB-001, the company’s 3D bioprinted corneal implant candidate, in a Phase I clinical trial. The legally blind patient was ...
Topcon Gains US 510(k) Clearance for Omnia 4-in-1 Diagnostic Device
Topcon Healthcare announced on Nov. 18 the FDA 510(k) clearance and US commercial launch of Omnia, an automated four-in-one diagnostic device that integrates objective refraction, keratometry, tono...
iOR Partners Rolls Out MD-OD Office-Based Collaboration Model
Kansas City, Missouri-based iOR Partners reported Nov. 12 that it was rolling out a newcollaboration model designed to bring together ophthalmologists (MDs) and optometrists (ODs). iOR Partners dev...
US FDA Approves Eylea HD for RVO, Plus Monthly Dosing in All Approved Indications
Regeneron Pharmaceuticals announced Nov. 19 that the US FDA had approved Eylea HD (aflibercept 8 mg) for macular edema following retinal vein occlusion (RVO), with dosing up to every eight weeks af...
Cellution Launches AmnioPlast Allografts in US for Ocular Surface Repair
Cellution Biologics announced Nov. 19 the US launch of its AmnioPlast 1 monolayer and AmnioPlast Double dual-layer dehydrated amnion membrane allografts for ocular surface repair. The Roswell, Geor...
New Brain Stimulation Approach Improves Vision Recovery After Stroke
Researchers at Switzerland-based Ecole Polytechnique Fédérale de Lausanne reported Nov. 17 that they had successfully tested a new brain stimulation treatment to improve vision recovery in stroke p...
Two Leading Eye Banks Based in Southeastern US Announce Merger
Two US eye banks, Advancing Sight Network and Miracles In Sight, announced Nov. 6 that they would merge and begin operating as one on Jan. 1, 2026. Advancing Sight Network, of Birmingham, Alabama, ...
Lilly, MeiraGTx Sign Ophthalmic Gene Therapy Deal Worth Up to $475 Million
MeiraGTx Holdings announced Nov. 10 that it granted drugmaker Eli Lilly exclusive worldwide rights to its AAV-AIPL1 gene therapy program targeting Leber congenital amaurosis 4 (LCA4). Lilly will al...
Q3-2025 Ophthalmic Revenue Roundup for Alcon, Santen, Immunocore, STAAR, Harrow, and Five Others
Alcon reported Nov. 11 that its Q3-2025 net sales totaled $2.6 billion, a 6 percent increase over $2.4 billion in Q3-2024. Surgical net sales for implantables, consumables, and equipment/other were...
Sydnexis Gains UK Approval for Low-Dose Atropine Drops in Pediatric Myopia
Sydnexis announced Nov. 6 that the UK’s Medicines and Healthcare Products Regulatory Agency had granted marketing authorization for Ryjunea, the company’s low-dose atropine formulation for slowing ...
STAAR Solicits New Bids Under Amended Deal with Alcon, Moves Shareholder Vote to Dec. 19
STAAR Surgical reported Nov. 7 that it had amended its merger agreement with Alcon to allow STAAR to solicit new buyers for 30 days under a new “go-shop” period ending Dec. 6. STAAR also delayed to...
Richard Pazdur, MD, to Lead US FDA’s Center for Drug Evaluation and Research
The US FDA reported Nov. 11 that oncologist Richard Pazdur, MD, had been named director of the Center for Drug Evaluation and Research (CDER). Pazdur is a 26-year veteran of the FDA and the foundin...
UK High Court Ruling Paves Way for Launch of Alvotech’s Aflibercept Biosimilar
Iceland’s Alvotech announced Nov. 10 that the UK High Court had rejected an injunction from Eylea marketers Regeneron and Bayer against Alvotech and its contract manufacturing organization. The dec...
Kwangdong Submits NDA in South Korea for Tenpoint’s Presbyopia Drop
Tenpoint Therapeutics announced Nov. 5 that Kwangdong Pharmaceutical had submitted a new drug application (NDA) to the Ministry of Food and Drug Safety in South Korea for Brimochol PF, a combinatio...
Mallinckrodt Spins Off Generics Business, Rebrands as Keenova
Drugmaker Mallinckrodt announced Nov. 10 that it had completed the planned spinoff of its Par Health generic pharmaceuticals and sterile injectables businesses and had rebranded as Keenova Therapeu...
PolyActiva, RareSight to Collaborate on Rare Pediatric Retinal Diseases
Australia’s PolyActiva announced Nov. 5 that it would collaborate with RareSight, of Menlo Park, California, an ophthalmology-focused life sciences company committed to advancing therapies for rare...
CMS’ Changes to Final 2026 Physician Fee Schedule Include Two Significant Cuts
The Centers for Medicare and Medicaid Services (CMS) made two significant cuts to parts of the formula used to calculate physicians’ Medicare procedure fees in 2026, despite heavy lobbying by the m...
Viridian Submits BLA to US FDA for Veligrotug in Thyroid Eye Disease
Viridian Therapeutics announced Nov. 3 that it had submitted a biologics license application (BLA) to the US FDA for veligrotug, the company’s intravenous treatment candidate for thyroid eye diseas...
4DMT Licenses Retinal Gene Therapy Candidate to Otsuka for Asia-Pacific
4D Molecular Therapeutics announced Oct. 30 a strategic partnership with Otsuka Pharmaceutical Co. to develop and commercialize retinal gene therapy candidate 4D-150 in the greater Asia-Pacific (AP...
Q3-2025 Ophthalmic Revenue Roundup for Amgen, AbbVie, Hoya, Glaukos, Apellis, Astellas, and Four Others
Amgen, of Thousand Oaks, California, reported Nov. 4 that its Q3-2025 revenue from Tepezza was $560 million, a 15 percent increase over $488 million in Q3-2024. The total consisted of $518 million ...
Samsung Bioepis to Commercialize Byooviz in Europe Starting in January 2026
South Korea’s Samsung Bioepis announced Oct. 29 that it would assume responsibility for the marketing of Byooviz (ranibizumab), a Lucentis biosimilar, in Europe upon the transfer of commercial righ...
UK Accepts Conditional Marketing Application for Belite Bio’s Tinlarebant in Stargardt
Belite Bio announced Nov. 2 that the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) had agreed to accept a conditional marketing authorization application for oral tinlarebant for ...
FDA Clears Way for US Patient to Receive GenSight’s Lumevoq for LHON
France’s GenSight Biologics announced Oct. 30 that the FDA had granted permission for a single patient in the US to be treated with GS010, also known as Lumevoq, GenSight’s intravitreal gene therap...
Outlook Resubmits BLA to US FDA for Ophthalmic Bevacizumab (Lytenava)
Outlook Therapeutics reported Nov. 3 that it had resubmitted its biologics license application (BLA) to the US FDA for ONS-5010 (Lytenava), an ophthalmic formulation of bevacizumab for wet age-rela...
Visara Licenses Retinal Candidate to Everest for Greater China, Other Asian Countries
NovaBridge Biosciences announced Oct. 29 that its ophthalmic subsidiary, Visara, had licensed retinal treatment candidate VIS-101 to Everest Medicines for greater China, Singapore, South Korea, and...
Roche Reports Mixed Phase III Data for Vamikibart in Uveitic Macular Edema
Swiss drugmaker Roche reported on Oct. 16 mixed Phase III results for vamikibart, an IL-6 inhibitor being developed to address inflammation in uveitic macular edema (UME). Vamikibart, if approved, ...
US FDA Rejects Sydnexis’ Atropine Drop for Pediatric Myopia
Sydnexis announced Oct. 23 that the US FDA had issued a complete response letter rejecting the company’s new drug application (NDA) for SYD-101, a low-dose atropine formulation to slow the progress...
Lilly to Acquire Adverum in Deal Worth Up to $262 Million
Drugmaker Eli Lilly announced Oct. 24 that it would acquire Adverum Biotechnologies, developer of Ixo-vec, a Phase III intravitreal gene therapy candidate targeting wet age-related macular degenera...
STAAR Moves Shareholder Vote on Alcon Acquisition to Dec. 3
STAAR Surgical on Oct. 27 postponed until Dec. 3 its special meeting of shareholders to vote on Alcon’s acquisition of the company. STAAR also set a new record date of Oct. 24. Stockholders who hel...
Q3-2025 Ophthalmic Revenue Roundup for Bausch + Lomb, Roche, Regeneron, Novartis
Bausch + Lomb reported Oct. 29 that its Q3-2025 revenue totaled $1.3 billion, a 7 percent increase over $1.2 billion in Q3-2024. Ophthalmic pharmaceuticals segment revenue was $330 million, an 8 pe...
US FDA Again Rejects Xbrane’s Ranibizumab Biosimilar Candidate
Sweden’s Xbrane Biopharma announced Oct. 19 that the US FDA had issued a complete response letter rejecting the company’s resubmitted biologics license application (BLA) for its Lucentis (ranibizum...
US FDA Rejects Eylea HD Prefilled Syringe over Inspection at Catalent Site
Regeneron reported in its Q3-2025 results on Oct. 28 that the US FDA had issued a complete response letter rejecting the supplemental biologics license application (sBLA) for a prefilled syringe of...
China Medical System Acquires Rights in China to Novartis’ Beovu and Lucentis
China Medical System Holdings of Hong Kong announced Oct. 27 that its ophthalmic subsidiary CMS Vision had acquired exclusive distribution rights in mainland China for Novartis’ retinal treatments ...
Amsurg Acquires ASC in South Carolina, Expanding Footprint in State
Amsurg, of Nashville, Tennessee, reported Oct. 28 that it had acquired Surgery Center of Conway, in Conway, South Carolina, its fourth center in the state. Amsurg, a leader in ambulatory surgery ce...
Viatris, Locus Biosciences to Collaborate on Ophthalmic Antibacterial Therapies
Viatris and Locus Biosciences announced on Oct. 28 a research collaboration to develop novel products targeting ophthalmic bacterial infections. No financial details about the collaboration were di...
VEO Ophthalmics Launches PeriVision’s VisionOne VR Visual Field Platform in US
VEO Ophthalmics announced Oct. 16 that the VisionOne VR Visual Field platform is now available in the US through a strategic partnership with Switzerland’s PeriVision. No financial details about th...
Alcon-STAAR Deal Up in the Air as Shareholder Vote is Delayed
STAAR Surgical adjourned until Nov. 6 the shareholder vote for its planned sale to Alcon during a virtual special meeting of shareholders on Oct. 23. Alcon made public on Aug. 5 its plans to purcha...
US FDA Approves Glaukos’ Epioxa Epi-On Crosslinking Therapy for Keratoconus
Glaukos, of Aliso Viejo, California, reported Oct. 20 that the US FDA had approved Epioxa, an epi-on version of the company’s iLink corneal crosslinking therapy for keratoconus. Thomas Burns, Glauk...
J&J Vision Surgical Posts Q3-2025 Revenue of $383 Million
J&J Vision’s Q3-2025 global surgical vision revenue totaled $383 million, a 14.9 percent increase over $333 million in Q3-2024, parent Johnson & Johnson, of New Brunswick, New Jersey, reported Oct....
Topcon Healthcare to Acquire AI Screening Company Toku
Topcon Healthcare announced Oct. 17 that it had signed a definitive agreement to acquire Toku, an artificial intelligence (AI) health technology company originally founded in New Zealand. No financ...
Santen Acquires Rights in South Korea to Novartis’ Beovu and Lucentis
Santen Pharmaceutical announced Oct. 20 that it had acquired exclusive distribution rights in South Korea for Novartis’ retinal treatments Beovu (brolucizumab) and Lucentis (ranibizumab). Both Beov...
AviadoBio Signs Option to License UgeneX’ Optogenetics Gene Therapy Candidate
UK-based AviadoBio announced Oct. 9 that it had signed an option agreement to license UGX-202, an AAV-based optogenetic treatment candidate targeting retinitis pigmentosa, from China’s UgeneX Thera...
US FDA Selects Abeona’s XLRS Candidate for Rare Disease Endpoint Program
Abeona Therapeutics announced Oct. 13 that the US FDA had selected its ABO-503 gene therapy candidate for X-linked retinoschisis (XLRS) to participate in the Rare Disease Endpoint Advancement (RDEA...
US FDA Grants Breakthrough Status to Nacuity’s Oral Candidate for RP
Nacuity Pharmaceuticals announced Oct. 2 that the US FDA had granted breakthrough therapy designation to NPI-001 (N-acetylcysteine amide) tablets, Nacuity’s oral treatment candidate for retinitis p...
US FDA Grants Orphan Drug Status to AAVantgarde’s Stargardt Candidate
Italy’s AAVantgarde Bio announced Oct. 2 that the US FDA had granted orphan drug status to AAVB-039, its gene therapy candidate for Stargardt disease. The candidate previously gained the FDA’s fast...
Verséa Ophthalmics Launches as Independent Company Named Defeye
Verséa Ophthalmics announced Oct. 1 that it had launched as an independent company with the new name Defeye. It previously was a subsidiary of Verséa Health. Defeye, of Sarasota, Florida, has a por...
Valitor Appoints Gregory D. Kunst as Chief Executive Officer
Valitor, of Berkeley, California, announced Oct. 17 that it had appointed Gregory D. Kunst as chief executive officer and a member of the board of directors. Kunst replaces interim CEO Michael Ostr...
BVI Medical’s FineVision HP Trifocal IOL Gains US FDA Approval
BVI Medical announced Oct. 14 that the US FDA had approved its FineVision HP trifocal intraocular lens (IOL). The company said the lens, the world’s first trifocal IOL, was backed by 15 years of cl...
Optos Launches the Silverstone RGB Advanced Retinal Imaging System
UK-based Optos announced Oct. 15 that it had launched its next-generation Silverstone RGB system for retinal imaging. The device is designed to allowclinicians to capture, visualize, and analyze pa...
Iantrek Announces US Commercial Launch of AlloFlo Uveo Biostent for Glaucoma
Iantrek announced Oct. 14 the US commercial launch of the AlloFlo Uveo, a novel minimally invasive glaucoma surgical (MIGS) device targeting the uveoscleral drainage pathway. The AlloFlo Uveo allog...
EssilorLuxottica Acquires Screening Software Company RetinAI
Eyewear conglomerate EssilorLuxottica announced Oct. 15 that it would acquire Swiss company Ikerian, operating under the RetinAI brand. RetinAI develops tools to collect, process, and grade large-s...
Epion Therapeutics Forms Strategic Partnership with Oculus
Epion Therapeutics announced Oct. 7 that it had entered a strategic partnership with Germany’s Oculus, maker of the Pentacam corneal tomographer. The partnership comes in conjunction with Epion clo...
Biotech Healthcare Launches Optiflex Xtense Comfort Plus EDOF IOL in Europe
Biotech Healthcare announced Sept. 23 that it had launched the Optiflex Xtense Comfort Plus extended-depth-of-focus (EDOF) intraocular lens at the ESCRS 2025 congress in Copenhagen, Denmark. Biotec...
OcuSciences’ OcuMet Beacon Retinal Imager Gains CE Marking
OcuSciences, of Ann Arbor, Michigan, announced Oct. 15 that its OcuMet Beacon retinal imager had gained CE marking under the European Medical Device Regulation. The device gained US FDA 510(k) clea...
Konan Medical’s ObjectiveField Perimeter Gains CE Marking
Konan Medical announced Oct. 10 that its ObjectiveField visual field analyzer had gained CE marking under the European Medical Device Regulation. The ObjectiveField is an objective perimeter design...
US FDA Approves Celltrion’s Aflibercept Biosimilar Branded Eydenzelt
South Korea’s Celltrion announced Oct. 9 that the US FDA had approved Eydenzelt, an aflibercept (Eylea) biosimilar. Eydenzelt (aflibercept-boav 40 mg/mL solution for injection) is indicated for wet...
US FDA Gives Green Light to Trial of Avisi’s VisiPlate Aqueous Shunt for Glaucoma
Avisi Technologies announced Oct. 14 that the US FDA had signed off on its investigational device exemption (IDE) submission, allowing the company to proceed with a trial of the VisiPlate aqueous s...
RetinalGenix Partners with Genotyping Lab on Disease Detection Through the Eye
RetinalGenix Technologies announced Oct. 1 that it would collaborate with genotyping lab RGEN, of West Virginia, to advance the early detection of neurodegenerative, systemic, and retinal diseases....
Ashvattha Names Bob Dempsey as Interim CEO
Ashvattha Therapeutics, of Redwood City, California, announced Oct. 14 that it had appointed Robert J. Dempsey as interim chief executive officer. The move follows the company’s release of positive...
Nova Eye’s iTrack Advance Canaloplasty Device Approved in China
Australia’s Nova Eye Medical announced Sept. 30 that China’s National Medical Products Administration had approved the marketing of the company’s iTrack Advance canaloplasty device for glaucoma. Th...
US Senator to Review AMA’s Fee Structure to Use its CPT Code Set
US Senator Bill Cassidy, MD, R-Louisiana, has opened a review into the American Medical Association (AMA), claiming it charges “exorbitant fees” for use of its CPT code set. The code set is created...
Teresa Puthussery, PhD, OD, Named 2025 MacArthur Fellow
Teresa Puthussery, PhD, a neurobiologist and optometrist, has been named one of the 22 MacArthur Fellows for 2025. The MacArthur Foundation, based in Chicago, Illinois, annually selects fellows who...
Oculis Accelerates Privosegtor Toward Pivotal Trials in Neuro-ophthalmology
Swiss company Oculis announced Oct. 6 that it will advance Privosegtor into a pivotal program for two indications in neuro-ophthalmology following a positive meeting with the US FDA. Privosegtor is...
Rayner Gains US FDA Approval of RayOne EMV Toric IOL
UK-based Rayner announced Oct. 13 that the US FDA had approved its RayOne EMV Toric intraocular lens (IOL), and the lens is now available. Rayner CEO Tim Clover said: “The long-awaited FDA approval...
Generic Drugmakers with US Sources Now Eligible for FDA Priority Review
The US FDA reported Oct. 3 that a new pilot program would speed the approval process for some generic drugmakers: They would be eligible for priority review if they conducted any required bioequiva...
Regulators in China Accept BLA for DME Candidate from Santen, RemeGen
Japan’s Santen Pharmaceutical and partner RemeGen announced Sept. 30 that China’s Center for Drug Evaluation had accepted the biologic license application (BLA) for retinal treatment candidate RC28...
US FDA Gives Green Light to Phase I/II Trial of Complement’s GA Gene Therapy Candidate
Complement Therapeutics announced Oct. 8 that the US FDA had signed off on its investigational new drug (IND) application, allowing the company to proceed with a Phase I/II trial of CTx001, a gene ...
Vivani Delays Record Date for Cortigent Spinoff Due to Shutdown
Vivani Medical, of Alameda, California, reported Oct. 3 that it has temporarily withdrawn the record date for spinning off its Cortigent subsidiary due to delays arising from the current shutdown o...
Harrow Names Frank Mullery as CEO of ImprimisRx Subsidiary
Harrow, of Nashville, Tennessee, announced Oct. 6 that Frank Mullery had been appointed chief executive officer of its ImprimisRx ophthalmic compounding subsidiary. Harrow said Mullery is a senior ...
Myopia Lenses from EssilorLuxottica Gain US FDA De Novo Marketing Authorization
Eyewear giant EssilorLuxottica and the US FDA announced Sept. 25 that the company’s Stellest spectacle lenses had gained de novo marketing authorization to slow the progression of myopia in childre...
Harrow to Expand Access for All Program to Full Drug Portfolio
Harrow, of Nashville, Tennessee, reported Sept. 25 that it was expanding its Vevye Access for All program to the rest of its portfolio, making it easier and more affordable for patients to obtain t...
Lenz Launches Vizz Drops for Presbyopia in US
Lenz Therapeutics announced Sept. 30 that Vizz (aceclidine ophthalmic solution) 1.44% for presbyopia is now commercially available in the US. The company said its sales force was distributing sampl...
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