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2025 in Review: Sydnexis’ Atropine Drop for Myopia Rejected in US, Approved Elsewhere
2025 in Review: Sydnexis’ Atropine Drop for Myopia Rejected in US, Approved Elsewhere

The US FDA’s decision in October 2025 to reject Sydnexis’ low-dose atropine drop for myopia touched off an abundance of discussion among eye care providers—many of whom have used compounded low-dos...

2025 in Review: EssilorLuxottica Entrenches Ophthalmic Strategy with 2025 Deals
2025 in Review: EssilorLuxottica Entrenches Ophthalmic Strategy with 2025 Deals

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...

2025 in Review: Multiple Cornea Therapeutic Milestones Achieved in Late 2025
2025 in Review: Multiple Cornea Therapeutic Milestones Achieved in Late 2025

The fourth quarter of 2025 saw multiple breakthroughs in cornea transplant therapies and corneal crosslinking. In October, the US FDA approved Epioxa, an epi-on version of Glaukos’ iLink corneal cr...

2025 in Review: Next-Generation PC-IOL Designs Drive Global Market Expansion in 2025
2025 in Review: Next-Generation PC-IOL Designs Drive Global Market Expansion in 2025

Global demand in 2025 for presbyopia-correcting intraocular lenses (PC-IOLs) increased meaningfully, driven by improved optical performance, broader participation by leading IOL manufacturers, decl...

2025 in Review: Encelto for MacTel Nabs Many Firsts, Opens New Area of Study
2025 in Review: Encelto for MacTel Nabs Many Firsts, Opens New Area of Study

US FDA approval of Encelto in March 2025 handed Neurotech a cluster of firsts. It was the first therapy approved to treat macular telangiectasia type 2 (MacTel), the first encapsulated cell therapy...

Virtual Retina Could Help Unlock New Treatments for Vision Loss
Virtual Retina Could Help Unlock New Treatments for Vision Loss

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...

Clinical Trial Updates for Ophthalmic Candidates , January 2026
Clinical Trial Updates for Ophthalmic Candidates , January 2026

Market Scope is tracking companies that have announced clinical trial updates or milestone achievements.

Alvotech, Teva Reach Deal with Regeneron to Bring Eylea Biosimilar to US No Later than H2-2026
Alvotech, Teva Reach Deal with Regeneron to Bring Eylea Biosimilar to US 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 ...

Weekly Poll of MDs, US and Western Europe, January 2026
Weekly Poll of MDs, US and Western Europe, January 2026

Kodiak Leads Latest Ophthalmic Fundraising with $184 Million Offering
Kodiak Leads Latest Ophthalmic Fundraising with $184 Million Offering

Kodiak Sciences led recent ophthalmic fundraising efforts with a $184 million public offering to advance its Phase III candidates for retinal disease. Financing announced in the past four weeks tot...

January 2026 Ophthalmic News Briefs
January 2026 Ophthalmic News Briefs

Italy-based NTC reported Dec. 10 that it had completed its acquisition of Pharmathen’s ophthalmology business. No financial details were provided. NTC said the move gives it a global portfolio of g...

STAAR Agrees to Leadership Changes Following Failed Acquisition Attempt
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
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 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
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
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
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 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, 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
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 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
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 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, 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
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
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 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
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
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
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
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, 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
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
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
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
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 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 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
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 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
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
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
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 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 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
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 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
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 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 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...

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