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.
Outlook Therapeutics reported Nov. 27 that its ophthalmic bevacizumab candidate Lytenava (ONS-5010) did not meet its non-inferiority endpoint in topline results from the NORSE EIGHT trial vs. ranib...
Japan’s Astellas Pharma announced Nov. 19 that the US FDA had issued a complete response letter rejecting its supplemental new drug application (sNDA) for Izervay seeking to expand the drug’s label...
Ocugen announced Nov. 20 that the European Medicines Agency had granted orphan medicinal product status for OCU410ST, a gene therapy candidate targeting ABCA4-associated retinopathies, including St...
Nevada-based Avant Technologies and Ainnova Tech, of Houston, Texas, announced Nov. 20 that the two companies would advance Ainnova’s proprietary low-cost retinal camera packaged with the Vision AI...
Paris-based GenSight Biologics announced Nov. 13 that it had submitted an updated regulatory file for Lumevoq, its gene therapy candidate for Leber hereditary optic neuropathy (LHON), to French reg...
Atsena Therapeutics announced Nov. 13 that it had granted exclusive commercial rights for its Leber congenital amaurosis type 1 (LCA1) gene therapy candidate ATSN-101 to Nippon Shinyaku in the US a...
Alkeus Pharmaceuticals announced Nov. 18 that the US FDA had granted rare pediatric disease and fast track designations to gildeuretinol (ALK-001), its oral therapy candidate for Stargardt disease....
The Centers for Medicare and Medicaid Services (CMS) published on Nov. 1 the final schedule of Medicare reimbursement fees for physicians in 2025. It also released its facility fee payments for ASC...
Amgen has launched its Eylea biosimilar, Pavblu (aflibercept-ayyh), after a victory in October in its patent fight with Regeneron. Fierce Pharma reported that a trio of US circuit judges on Oct. 22...
Korea’s Samsung Bioepis and Biogen, of Cambridge, Massachusetts, announced Nov. 18 that the European Commission had granted marketing authorization for Opuviz (aflibercept-yszy), an Eylea biosimila...
MeiraGTx, with offices in London and New York, announced Nov. 13 that it would submit a marketing authorization application in the UK under “exceptional circumstances” for AAV-AIPL1, its gene thera...
Swiss drugmakerSandoz announced Nov. 15 that the European Commission had granted marketing authorization for Afqlir (aflibercept), an Eylea biosimilar. Afqlir, available as a 2 mg vial kit and pre-...
Gene therapies again generated buzz at the 2024 AAO meeting—as they have at recent meetings—but perhaps most exciting were reports of a treatment that could partially restore severe vision loss fro...
Kalaris Therapeutics announced Nov. 8 that it would merge with biotech company AlloVir in an all-stock transaction to advance Kalaris’ next-generation anti-VEGF candidate TH103 for exudative retina...
Clearside Biomedical’s Asia-Pacific partner, Arctic Vision, announced Nov. 7 that it had licensed Chinese commercialization rights for ARVN001, marketed in the US as Xipere, to Santen Pharmaceutica...
Japanese biopharmaceutical company Feliqs announced Nov. 1 that the US FDA had granted its lead asset, FLQ-101, fast track designation for the prevention of retinopathy of prematurity (ROP). FLQ-10...
Ophthalmology remains an appealing investment, driven largely by procedural growth. While hundreds of companies are working toward technology enhancements and innovative therapies, ophthalmology pr...
Science Corporation, of Alameda, California, reported Oct. 22 preliminary results that showed its Prima retinal implant allowed for functional vision in patients who had lost their central visual f...
Neurotech Pharmaceuticals announced Nov. 8 that it had submitted additional data requested by the US FDA to support its biologic license application (BLA) for NT-501, an encapsulated cell therapy i...
LumiThera announced Nov. 4 that the US FDA had granted market authorization through the de novo pathway for the Valeda photobio-modulation system for treatment of patients with dry age-related macu...
EyePoint Pharmaceuticals led recent ophthalmic fundraising efforts with a $161 million upsized underwritten public offering. Proceeds in part will fund clinical development of Duravyu. Financing an...
Ben Yerxa, PhD, and George Magrath, MD, say they have a way out of the jungle in which ocular gene therapy development has been trapped since the US FDA approved Luxturna in 2017. “You have to be r...
The celebrations and excitement that accompanied the launch in 2023 of the first two drugs approved in the US for the treatment geographic atrophy (GA) gave way to a hangover and regrets at the 202...
Recent studies indicate that up to 6 percent of the US population is currently taking a GLP-1 receptor agonist, a class of drugs prescribed to help manage blood glucose levels for diabetes and weig...
Alcon launched at the 2024 AAO meeting two new retinal surgical devices—Unifeye for air-gas exchange and Unipexy for retinopexy. Each is a one-person, hand-held, single-use gas delivery device. The...
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.
Market Scope is tracking companies that have announced clinical trial updates or milestone achievements.
Pine Pharmaceuticals, of Tonawanda, New York, stopped repackaging Avastin (bevacizumab) for ophthalmic use in October 2024, according to the American Academy of Ophthalmology and American Society o...
Market Scope is tracking companies that have announced new candidates to diagnose and treat eye disease.
Heidelberg Engineering announced Oct. 14 that the US FDA had granted 510(k) clearance to its Flex Module for the Spectralis diagnostic imaging platform. The Flex Module mounts the Spectralis to a m...
LumiThera announced Nov. 4 that the US FDA had granted market authorization through the de novo pathway for the Valeda photobiomodulation system for treatment of patients with dry age-related macul...
AbbVie, of North Chicago, Illinois, reported Oct. 30 that its Q3-2024 eye care net revenue was $525 million, a 13.5 percent decline (-11.2 percent cc) from $605 million in Q3-2023. Restasis revenue...
Neurotech Pharmaceuticals announced Nov. 8 that it had submitted additional data requested by the US FDA to support its biologic license application (BLA) for NT-501, an encapsulated cell therapy i...
HuidaGene Therapeutics announced Nov. 4 that the US FDA had cleared its investigational new drug (IND) application for a Phase I trial of HG202, a gene therapy candidate targeting wet age-related m...
Japan’s Astellas Pharma announced Oct. 28 that it had withdrawn its marketing authorization application in the EU for avacincaptad pegol, a complement-5 inhibitor targeting geographic atrophy (GA) ...
Regeneron of Tarrytown, New York, reported Oct. 31 that its Q3-2024 US revenue for Eylea (aflibercept) 2 mg and Eylea HD (a higher dose of aflibercept at 8 mg) was $1.54 billion, a 3 percent increa...
Genentech, a member of the Roche Group, announced Oct. 18 positive topline one-year results from the postmarket Elevatum study evaluating Vabysmo (faricimab-svoa) for the treatment of diabetic macu...
Alkeus Pharmaceuticals reported positive topline results on Oct. 23 from the Phase III SAGA trial of gildeuretinol acetate (ALK-001), a once-daily oral therapy candidate targeting geographic atroph...
RevOpsis Therapeutics announced Oct. 15 that it had been awarded a Small Business Innovation Research grant of $1.8 million from the National Eye Institute (NEI) to advance lead asset RO-104 for ex...
South Korean companies GC Biopharma and Novelty Nobility announced Oct. 28 that they would jointly research and develop a novel treatment candidate for geographic atrophy (GA). The companies said a...
Pine Pharmaceuticals, of Tonawanda, New York, stopped repackaging Avastin (bevacizumab) for ophthalmic use in October 2024, according to the American Academy of Ophthalmology and American Society o...
Swiss company Roche reported Oct. 23 that Q3-2024 Vabysmo sales were CHF 1 billion ($1.15 billion, converted on Oct. 23, 2024), a 59 percent increase over CHF 656 million in Q3-2023. The company sa...
Ocuphire Pharma announced Oct. 22 that it would acquire Opus Genetics in an all-stock transaction. The combined company will operate under the Opus name and will trade on the Nasdaq under the ticke...
Science Corporation, of Alameda, California, reported Oct. 22 preliminary results that showed its Prima retinal implant allowed for functional vision in patients who had lost their central visual f...
Eyenuk and the American Academy of Ophthalmology (AAO) reported Oct. 16 that they had teamed up under the AAO’s EyeCare America program to provide eye disease screening for underserved communities ...
The big news at the 24th Euretina congress was something that didn’t happen at the congress. The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) embarrassed Apelli...
Orasis Pharmaceuticals led recent ophthalmic fundraising efforts with $78 million in Series D and structured capital to support the launch of Qlosi drops for presbyopia. Financing announced in the ...
Market Scope is tracking companies that have announced new candidates to diagnose and treat eye disease.
European regulators’ repeated rejection of Syfovre made one thing very clear to retina specialists at Euretina: “Treatment should have an impact on everyday function,” said Thomas Ach, MD (Germany)...
Experienced retina surgeons among the approximately 8.1 thousand attendees at Euretina in Barcelona, Spain, were underwhelmed by the surgical devices that industry had on display. “There is nothing...
The negative opinion of Syfovre by a key EU regulatory committee has thrown the global marketing plans for complement inhibitors for GA into disarray. Two companies—Apellis Pharmaceuticals and Aste...
Market Scope is tracking companies that have announced clinical trial updates or milestone achievements.
Harrow reported Sept. 25 that it is creating nearly 150 new jobs as it expands its corporate headquarters in Nashville, Tennessee. The move follows the company increasing its total leased space in ...
Europe’s Committee for Medicinal Products for Human Use (CHMP) issued positive opinions on Sept. 19 for two new aflibercept (Eylea) biosimilars—Afqlir from Swiss drugmaker Sandoz and Opuviz, which ...
Oculus has announced the addition of frequency doubling perimetry (FDP) to its Easyfield VR visual field diagnostic headset. The German ophthalmic diagnostic company, with US headquarters in Arling...
Nanoscope Therapeutics announced Oct. 10 that it had met with the US FDA regarding MCO-010, an ambient-light-activatable optogenetic monotherapy to restore vision in patients with advanced retiniti...
Ocugen announced Oct. 9 that the US FDA had lifted its clinical hold on the investigational new drug (IND) application for a Phase I trial of OCU200, a recombinant fusion protein consisting of tums...
Iridex reported Oct. 3 that it had appointed Patrick Mercer as chief executive officer, to go along with his role as president, effective Oct. 1. Mercer had also served as the company’s chief opera...
Australian drug developer Opthea announced Oct. 8 that it had appointed Parisa Zamiri, MD, PhD, as chief medical officer. Zamiri, an ophthalmologist, has clinical experience in medical retina, immu...
Oak Hill Bio, of Cambridge, Massachusetts, announced Oct. 7 that it had promoted Josh Distler, JD, to chief executive officer. Distler is a co-founder of Oak Hill and previously served as the compa...
Nashville, Tennessee-based Harrow reported Oct. 3 that it had relaunchedTriesence (triamcinolone acetonide injectable suspension) 40 mg/mL, a preservative‑free synthetic corticosteroid, in the US. ...
Surrozen announced Sept. 24 that development partner Boehringer Ingelheim will advance SZN-413, a bi-specific antibody targeting retinal vascular disease. The milestone triggers a $10 million payme...
Switzerland’s Rejuveron Life Sciences announced Sept. 19 that it had rebranded as Centenara Labs. The company develops and invests in therapeutic candidates to promote healthy aging. Centenara said...
Nanoscope Therapeutics announced Sept. 30 that it had acquired a license for CatCh optogenetic technology from Max Planck Innovation, the technology transfer arm of the Max Planck Society. Financia...
Priovant Therapeutics, of Durham, North Carolina, reported Sept. 23 that the US FDA had granted fast track designation for brepocitinib in non-infectious intermediate or posterior uveitis or panuve...
Atsena Therapeutics announced Sept. 17 that ATSN-201, its gene therapy candidate for X-linked retinoschisis (XLRS), had received the US FDA’s orphan drug designation. The candidate was granted rare...
Eyconis announced Sept. 19 that it had appointed Mark J. Bachleda, PharmD, MBA, as chief executive officer and a member of its board of directors. Bachleda has served in executive leadership roles ...
Luxa Biotechnology announced Oct. 1 that it had appointed Keith Dionne, PhD, as chief executive officer. Luxa, of Fort Lee, New Jersey, is advancing RPESC-RPE-4W, a cell product derived from adult ...
France’s Nicox announced Sept. 23 that it had signed an exclusive research and license option agreement with Glaukos for NCX 1728, Nicox’s novel nitric oxide (NO)-donating phosphodiesterase-5 (PDE5...
The FDA has approved Amgen’s Pavblu (aflibercept-ayyh), making it the fifth Eylea biosimilar to reach the milestone in the US in 2024. FDA records show Pavblu was approved Aug. 23. Labeling shows i...
Europe’s Committee for Medicinal Products for Human Use (CHMP) issued positive opinions on Sept. 19 for two new aflibercept (Eylea) biosimilars—Afqlir from Swiss drugmaker Sandoz and Opuviz, which ...
Microsurgical Technology (MST) announced Sept. 17 that it had partnered with Vista Ophthalmics to commercialize Vista’s products—the Vista 1-Step vitrectomy probe and the Vista IS for maintaining t...
Italy’s AAVantgarde Bio announced Sept. 9 that it had appointed Jayashree Sahni, MD, FRCOphth, EMBA, as chief medical officer. Sahni, a retina specialist, was senior global program clinical head at...
Apellis Pharmaceuticals announced Sept. 20 that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) had reaffirmed its June 2024 negative opinion on the company’s ...
India’s Remidio announced Sept. 13 that regulators there had approved its Medios DR software for autonomous detection of diabetic retinopathy (DR). Medios DR becomes the first ophthalmic artificial...
Ophthalmic manufacturer revenue in Q2-2024 totaled $11.7 billion. Revenue increased 2.6 percent from the same quarter in 2023 and increased 5.9 percent from Q1-2024. The total includes Market Scope...
US ophthalmologists reported that ophthalmic procedures increased 0.5 percent in Q2-2024 compared with the same quarter in 2023, according to Market Scope’s latest survey. Year-over-year performanc...
Roche faced an ophthalmic patent cliff in the US before Regeneron. First, Roche introduced an extended duration alternative to its flagship inhibitor of vascular endothelial growth factor (anti-VEG...
ONL Therapeutics led recent ophthalmic fundraising efforts with a $65 million Series D round to continue advancing its small-molecule Fas inhibitor for retinal disease. Financing announced in the p...
Finland’s Revenio Group announced Aug. 20 that its iCare subsidiary had assumed ownership of the Dutch artificial intelligence (AI) software company Thirona Retina. iCare had made a minority invest...
OcuDyne, of Brooklyn Park, Minnesota, reported Sept. 9 that it had successfully completed a pilot study using its Optic System to perform ophthalmic artery angioplasty in patients with geographic a...
Market Scope is tracking companies that have announced new candidates to diagnose and treat eye disease.
A study in mice at the Science of Light Center at Cincinnati Children’s shows that lighting conditions can change how newborn eyes develop, with darkness fostering the development of more rods, the...
Market Scope is tracking companies that have announced clinical trial updates or milestone achievements.
The attorneys general for Colorado, Georgia, Michigan, North Carolina, Texas, and Washington have filed suit in federal district court against Regeneron Pharmaceuticals, claiming the drugmaker infl...
Bausch + Lomb is working with Goldman Sachs to explore a sale of the company, the Financial Times reported Sept. 14, with private equity the most likely buyer. The move is being evaluated as a way ...
OcuDyne, of Brooklyn Park, Minnesota, reported Sept. 9 that it had successfully completed a pilot study using its Optic System to perform ophthalmic artery angioplasty in patients with geographic a...
Bayer subsidiary BlueRock Therapeutics announced Sept. 3 that the US FDA had cleared its investigational new drug application for a Phase I/IIa trial of OpCT-001, an induced pluripotent stem cell (...
China’s Skyline Therapeutics announced Sept. 3 that the US FDA had granted orphan drug designation to SKG1108, an intravitreal gene therapy candidate for retinitis pigmentosa (RP). SKG1108 is a rec...
Belite Bio announced Sept. 1 that it had appointed Hendrik P.N. Scholl, MD, MA, as chief medical officer, effective immediately. Scholl specializes in inherited retinal and macular dystrophies, and...
BioCryst Pharmaceuticals, of Durham, North Carolina, announced Sept. 5 that it had appointed Donald S. Fong, MD, MPH, as the company’s new chief medical officer, effective immediately. Fong joined ...
A study in mice at the Science of Light Center at Cincinnati Children’s shows that lighting conditions can change how newborn eyes develop, with darkness fostering the development of more rods, the...
Tern Therapeutics announced its launch Aug. 27, along with closing of a $15 million financing. The company also reported that it had licensed gene therapy candidates RGX-381 and RGX-181 (now design...
Visionix USA has announced the launch of its VX 610 non-mydriatic automated fundus camera. The VX 610 boasts a range of automated features, including auto alignment, auto focus, and auto capture, w...
Ocugen announced Aug. 26 that Health Canada had cleared the way for a Canadian Phase III trial of OCU400, a modifier gene therapy candidate for retinitis pigmentosa (RP). Ocugen, of Malvern, Pennsy...
The attorneys general for Colorado, Georgia, Michigan, North Carolina, Texas, and Washington have filed suit in federal district court against Regeneron Pharmaceuticals, claiming the drugmaker infl...
Finland’s Revenio Group announced Aug. 20 that its iCare subsidiary had assumed ownership of the Dutch artificial intelligence (AI) software company Thirona Retina. iCare had made a minority invest...
The Doheny Eye Institute announced Aug. 14 that SriniVas Sadda, MD, had been named the A. Ray Irvine Jr., MD, Endowed Chair. He also was recently named president of the Association for Research in ...
Biosimilar company Alvotech and its partner Advanz Pharma announced Aug. 15 that the European Medicines Agency (EMA) had accepted a marketing authorization application for AVT06, Alvotech’s propose...
Atsena Therapeutics announced Aug. 14 that ATSN-201, its gene therapy candidate for X-linked retinoschisis (XLRS), had received the US FDA’s rare pediatric disease designation. XLRS is a monogenic ...
Opus Genetics announced Aug. 20 that OPGx-LCA5, its gene therapy candidate for Leber congenital amaurosis (LCA) resulting from biallelic mutations in the LCA5 gene, had received the US FDA’s rare p...
SalioGen Therapeutics announced Aug. 19 that it had appointed Kalliopi “Kali” Stasi, MD, PhD, as chief medical officer. SalioGen said Stasi will be responsible for bringing the company’s SGT-1001, ...
Impressive new science and challenging business conditions topped the discussions at the American Society of Retina Specialists’ 2024 annual meeting. The conference took place July 17-20 in Stockho...
The US FDA granted two clearances through the ophthalmic device division using the 510(k) pathway in July 2024, according to the agency’s database. Topcon gained clearance for its Maestro2 OCT in c...
MeiraGTx led recent ophthalmic fundraising efforts with a $50 million offering of ordinary shares as it moves forward with its extensive pipeline of gene therapy candidates. Financing announced in ...
Market Scope is tracking companies that have announced clinical trial updates or milestone achievements.
Market Scope is tracking companies that have announced new candidates to diagnose and treat eye disease.
Ireland-based Mallinckrodt announced Aug. 6 that its H.P. Acthar Gel single-dose prefilled SelfJect injector was available in the US. The US FDA approved the supplemental new drug application for t...
AbbVie, of North Chicago, Illinois, reported July 25 that Q2-2024 net revenue for its eye care products totaled $533 million, a 13.3 percent decline (-10.9 percent cc) from $617 million in Q2-2023....
Swiss drugmaker Sandoz announced Aug. 12 that the US FDA had approved Enzeevu, an aflibercept (Eylea) biosimilar, for wet age-related macular degeneration (AMD). Enzeevu (aflibercept-abzv) will be ...
LumiThera announced Aug. 7 that a new Category III CPT code had been established, effective Jan. 1, 2025, to report “Photobiomodulation therapy of retina, single session.” The company said the code...
Ocugen announced Aug. 5 that the US FDA had approved an expanded access program to allow for the treatment of adults with retinitis pigmentosa (RP) with OCU400—a modifier gene therapy product candi...
Japan-based Hoya Corporation announced Aug. 1 that its medical care segment (IOLs, endoscopes, artificial bone) had revenue for the quarter ending June 30, 2024—the first quarter of its fiscal year...
Ireland-based Mallinckrodt announced Aug. 6 that its H.P. Acthar Gel single-dose prefilled SelfJect injector was available in the US. The US FDA approved the supplemental new drug application (sNDA...
Regeneron, of Tarrytown, New York, reported Aug. 1 that its Q2-2024 US revenue for Eylea was $1.53 billion, a 2 percent increase from $1.5 billion in Q2-2023. Eylea HD accounted for $304 million of...
Swiss drugmaker Roche announced July 30 that the European Commission had approved Vabysmo for a third indication, the treatment of macular edema due to retinal vein occlusion (RVO). Vabysmo (farici...
Germany’s Novaliq announced July 29 that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) had recommended marketing authorization in the European Union for Vevi...
Adverum Biotechnologies announced Aug. 1 that Ixo-vec, its intravitreal gene therapy candidate for wet age-related macular degeneration (AMD), had received the US FDA’s regenerative medicine advanc...
Samsara Vision, of Far Hills, New Jersey, announced July 22 that the first SING IMT procedure for age-related macular degeneration (AMD) had been completed in China. The SING IMT, which stands for ...
Beacon Therapeutics announced July 24 that it had named Lance Baldo, MD, as chief executive officer, effective Aug. 12, 2024. Most recently, Baldo served as chief medical officer at Freenome, an ea...
Beacon Therapeutics led recent ophthalmic fundraising efforts with $170 million in Series B funding to advance its candidates for retinal disease. Financing announced in the past four weeks totaled...
Market Scope is tracking companies that have announced new candidates to diagnose and treat eye disease.
Market Scope is tracking companies that have announced clinical trial updates or milestone achievements.
Genentech, a member of the Roche Group, announced July 8 that it was reintroducing Susvimo, a refillable ranibizumab intravitreal implant for wet age-related macular degeneration (AMD) in the US, e...
Genentech, a member of the Roche Group, announced July 5 that the US FDA had approved the Vabysmo (faricimab-svoa) 6.0 mg single-dose prefilled syringe for wet age-related macular degeneration (AMD...
Bausch + Lomb announced July 23 that it had acquired dry eye diagnostic company Trukera Medical from its private equity owner, AccelMed Partners, and other shareholders. No financial details were d...
Beacon Therapeutics will evaluate Abeona Therapeutics’ patented AAV204 capsid for potential gene therapies for select ophthalmic indications, the companies announced July 11. AAV204, a novel AAV ca...
NexThera, of Busan, South Korea, announced July 16 that it had filed an investigational new drug (IND) application with the US FDA for a Phase I/IIa trial of NT-101, an eye drop candidate for wet a...
Outlook Therapeutics announced July 8 that the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) had granted marketing authorization for Lytenava, an ophthalmic formulation of bevaciz...
Genentech, a member of the Roche Group, announced July 5 that the US FDA had approved the Vabysmo (faricimab-svoa) 6.0 mg single-dose prefilled syringe for wet age-related macular degeneration (AMD...
Genentech, a member of the Roche Group, announced July 8 that it was reintroducing Susvimo, a refillable ranibizumab intravitreal implant for wet age-related macular degeneration (AMD) in the US, e...
Altos Biologics has submitted a marketing authorization application to the European Medicines Agency (EMA) for ALT-L9, an aflibercept (Eylea) biosimilar, according to a joint announcement by Altos ...
China’s DP Technology announced July 8 that it would advance DPT0415, a novel small molecule targeting lipoprotein‐associated phospholipase A2 (Lp-PLA2), as a potential oral treatment candidate for...
Alkeus Pharmaceuticals announced July 2 that Michel Dahan had joined the company as president and chief executive officer. He had served as a member of the board since January 2023. Alkeus, of Camb...
German companies Formycon and Klinge Biopharma announced June 28 that the US FDA had approved their aflibercept (Eylea) biosimilar for wet age-related macular degeneration (AMD), diabetic macular e...
Swiss drugmaker Roche announced June 28 that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) had recommended the extension of Vabysmo’s labeling to include tre...
RevOpsis Therapeutics, of San Carlos, California, announced June 17 that it had entered into a strategic manufacturing partnership with India’s Kemwell Biopharma. The deal aims to accelerate develo...
Alcon reported June 24 that itsUnity Vitreoretinal Cataract System (VCS) and Unity Cataract System (CS) had received US FDA 510(k) clearance. The company said it would be seeking real-world feedbac...
Nashville, Tennessee-based Harrow reported June 20 that it was moving closer to relaunching Triesence in 2024 after successfully achieving a production testing milestone. Triesence (triamcinolone a...
Neurotech Pharmaceuticals announced June 20 that the US FDA had accepted its biologic license application (BLA) and granted priority review for NT-501, an encapsulated cell therapy implant candidat...
4D Molecular Therapeutics announced June 24 that the US FDA had cleared its investigational new drug application for a Phase I clinical trial of 4D-175, an intravitreal gene therapy candidate targe...
US ophthalmologists reported that ophthalmic procedures decreased 6.0 percent in Q1-2024 compared with the same quarter in 2023, according to Market Scope’s latest survey. Year-over-year performanc...
Outlook Therapeutics announced May 28 that the European Commission had granted marketing authorization for Lytenava, an ophthalmic formulation of bevacizumab for the treatment of wet age-related ma...
The virus that causes COVID-19 can breach the blood-retinal barrier, with potential long-term consequences for eye health, researchers at the University of Missouri School of Medicine have discover...
An analysis of more than 3,100 older adults, published May 23 in JAMA Ophthalmology, showed that low-dose aspirin taken for three years did not affect the incidence or progression of age-related ma...
Apellis Pharmaceuticals reported June 10 that Syfovre (pegcetacoplan injection), its treatment for geographic atrophy (GA), preserved visual function at 36 months in the GALE long-term extension st...
Market Scope is tracking companies that have announced clinical trial updates or milestone achievements.
Opthea led recent ophthalmic fundraising efforts with a $113.2 million placement and entitlement offer, as it continues to advance its wet AMD candidate. Financing announced in the past four weeks ...
Merck, of Rahway, New Jersey, announced May 29 that it was acquiring Eyebiotech Limited (EyeBio) for an upfront payment of $1.3 billion and up to $1.7 billion in future milestone payments. The deal...
Japan’s Nidek announced June 3 that it had launched the RS-1 Glauvas OCT system. The device is CE marked as a Class IIa device. Nidek said the RS-1 Glauvas’ streamlined workflow and advanced analyt...
Opus Genetics and Abu Dhabi’s Department of Health announced June 5 that they had agreed to collaborate on the development of gene therapies for patients with rare inherited retinal diseases in the...
An analysis of more than 3,100 older adults, published May 23 in JAMA Ophthalmology, showed that low-dose aspirin administered for three years did not affect the incidence or progression of age-rel...
Apellis Pharmaceuticals reported June 10 that Syfovre (pegcetacoplan injection), its treatment for geographic atrophy (GA), preserved visual function at 36 months in the GALE long-term extension st...
Adverum Biotechnologies announced June 11 that it had appointed Rabia Gurses Ozden, MD, as chief medical officer. Ozden is stepping down from the seat she held on Adverum’s board. Retina specialist...
Japan’s Nidek announced June 3 that it had launched the RS-1 Glauvas optical coherence tomography (OCT) system. The device is CE marked as a Class IIa device. Nidek said the RS-1 Glauvas’ streamlin...
Belite Bio announced June 12 that Japanese regulators had granted the Sakigake, or pioneer therapy, designation to its lead candidate, tinlarebant, an oral tablet targeting Stargardt disease. Belit...
LambdaVision, of Farmington, Connecticut, reported May 29 that it had secured the first closing of a seed round, let by Aurelia Foundry Fund, a fund spun out of Massachusetts Institute of Technolog...
Regenxbio announced June 12 that its chief operating officer, Curran Simpson, had been appointed president and chief executive officer. He will also join the board of directors. Co-founder Kenneth ...
Avirmax Biopharma announced May 30 that the US FDA had cleared its investigational new drug application for a Phase I/IIa clinical trial of its intravitreal gene therapy candidate targeting wet age...
Merck, of Rahway, New Jersey, announced May 29 that it was acquiring Eyebiotech Limited (EyeBio) for an upfront payment of $1.3 billion and up to $1.7 billion in future milestone payments. The deal...
Outlook Therapeutics announced May 28 that the European Commission had granted marketing authorization for Lytenava, an ophthalmic formulation of bevacizumab for the treatment of wet age-related ma...
South Korea-based HanAll Biopharma announced May 28 that it had licensed Turn Biotechnologies’ epigenetic reprogramming technology for eye and ear diseases. The company said the deal could be worth...
The FDA announced May 20 that it had approved the US’ first interchangeable biosimilars to Eylea (aflibercept)— Yesafili, from India’s Biocon Biologics, and Opuviz, which was jointly developed by B...
AbbVie, of North Chicago, Illinois, reported April 26 that its Q1-2024 eye care net revenue totaled $538 million, an 11.7 percent decline (-10.4 percent cc) from $608 million in Q1-2023. Restasis r...
A sparsely attended Champalimaud Vision Award Lecture at the 2024 ARVO meeting highlighted the work of St. John of Jerusalem Eye Hospital in Gaza, Jerusalem, and the West Bank. Leonor Beleza, presi...
Drug Farm, of Shanghai, China, announced May 17 that the US FDA had cleared its investigational new drug (IND) application for a Phase Ib trial of its DF-003, an oral alpha kinase 1 (ALPK1) inhibit...
Retina, The Journal of Retinal and Vitreous Diseases, has published new guidelines that represent best practices for injection of therapies into the suprachoroidal space (SCS). The article, publish...
The 2024 meeting of the Association for Research in Vision and Ophthalmology set a record as the largest ARVO meeting ever. The 11,631 registered attendees passed the old record of 10,224 set in Va...
Philip Troyk, PhD, and Brian Bussard are unsung heroes of the multi-decade effort to give blind people artificial vision by means of cortical implants. They want more people to join them. Troyk, a ...
Notal Vision announced May 16 that the US FDA had granted de novo marketing authorization for its patient-operated Scanly home optical coherence tomography (OCT) device. The Scanly uses artificial ...
RxSight led recent ophthalmic fundraising efforts with a $115 million public offering to continue commercialization of its Light Adjustable Lens portfolio. Financing announced in the past four week...
The FDA announced May 20 that it had approved the US’ first interchangeable biosimilars to Eylea (aflibercept)— Yesafili, from India’s Biocon Biologics, and Opuviz, which was jointly developed by B...
Science Corporation, of Alameda, California, reported April 25 that it had acquired the IP and related assets for the Prima retinal implant, developed by Pixium Vision SA, of France. Terms of the d...
Market Scope is tracking companies that have announced new candidates to diagnose and treat eye disease.
The European Society of Retina Specialists, or Euretina, reported April 20 that its president, retina specialist Ramin Tadayoni, MD, PhD, had died. He was 54. Tadayoni was attending the Brazilian R...
Partners Xbrane Biopharma, of Sweden, and Germany’s Stada announced May 10 that they had entered into an exclusive licensing agreement with biosimilar company Valorum Biologics to market their rani...
Many companies participate in ARVO’s annual meeting to catch the attention of external researchers and propel their research program or clinical trials forward. Two such companies in 2024 were John...
Artificial intelligence was a prominent topic at the 2024 ARVO meeting. Discussions ranged from using AI in published ophthalmic research to employing it in early detection and monitoring of eye di...
The Weisenfeld and Cogan awards and lectures at the 2024 ARVO meeting put a spotlight on inflammation. Martine Jager, MD, PhD (Netherlands), received the Weisenfeld Award in recognition of her pion...
Market Scope is tracking companies that have announced clinical trial updates or milestone achievements.
Taiwan-based Formosa Pharmaceuticals announced May 9 that it had entered into an exclusive licensing agreement with Tabuk Pharmaceuticals to market clobetasol propionate 0.05% eye drops for post-su...
Alcon reported May 13 that its Q1-2024 net sales were $2.4 billion, a 5 percent increase (+7 percent cc) over $2.3 billion in Q1-2023. Surgical net sales totaled $1.34 billion, consisting of $433 m...
Healio reported May 14 that the first-in-human bimanual vitrectomy performed with a robot had taken place at Belgium’s Ghent University Hospital. The case was presented at the Retina World Congress...
Partners Xbrane Biopharma, of Sweden, and Germany’s Stada announced May 10 that they had entered into an exclusive licensing agreement with biosimilar company Valorum Biologics to market their rani...
Outlook Therapeutics announced May 13 that it had submitted a marketing authorization application to the UK’s Medicines and Healthcare Products Regulatory Agency for ONS-5010 (bevacizumab gamma) fo...
Apellis Pharmaceuticals, of Waltham, Massachusetts, reported May 7 that its Q1-2024 US net product revenue for Syfovre was $137.5 million, compared with $18.4 million in Q1-2023. Syfovre gained US ...
EyePoint Pharmaceuticals reported May 6 that Duravyu (vorolanib intravitreal insert) missed its primary endpoint of improvement in Diabetic Retinopathy Severity Scale score in patients with non-pro...
Remidio Inc., the US arm of India-based Remidio, announced May 7 that it had placed its thousandth FOP-NM hand-held fundus camera in the US. Remidio’s FOP-NM is the world’s first smartphone-based n...
Aeye Health announced April 30 that the US FDA had approved the company’s autonomous artificial intelligence-aided screening technology for diabetic retinopathy (DR) using a hand-held retinal camer...
OcuTerra Therapeutics, of Boston, Massachusetts, announced May 1 on LinkedIn that it would wind down operations. The company had been developing nesvategrast (OTT166 5%), an eye drop candidate for ...
Science Corporation, of Alameda, California, reported April 25 that it had acquiredthe IP and related assets for the Prima retinal implant, developed by Pixium Vision SA, of France. Terms of the de...
Aldeyra Therapeutics said April 25 that it planned to initiate a pivotal Phase II/III trial for ADX-2191 (methotrexate injection) in patients with retinitis pigmentosa due to rhodopsin misfolding m...
China-headquartered Eluminex Biosciences announced April 30 that the US FDA had accepted its investigational new drug (IND) application for EB-105, a tri-specific fusion antibody candidate for diab...
Topcon Healthcare announced April 26 that it had appointed Ali Tafreshi as CEO and president. The company said Tafreshi will lead the company’s focus on “oculomics”—diagnosing not just eye health b...
The European Society of Retina Specialists, or Euretina, reported April 20 that its president, retina specialist Ramin Tadayoni, MD, PhD, had died. He was 54. Tadayoni was attending the Brazilian R...
Swiss company Roche reported April 24 that Vabysmo sales in Q1-2024 were CHF 847 million ($926.5 million, calculated April 24, 2024), up from CHF 432 million (US $487 million) in Q1-2023. Vabysmo r...
Sweden’s Xbrane Biopharma announced April 21 that the US FDA had issued a complete response letter rejecting Xbrane’s ranibizumab biosimilar, branded in Europe as Ximluci. The company said regulato...
The National Eye Institute (NEI) announced April 8 that researchers from the Medical College of Georgia at Augusta University had established a database of the proteins found in the eye’s aqueous h...
The Centers for Medicare and Medicaid Services (CMS) has issued J-codes for Glaukos’ iDose, Regeneron’s Eylea HD, and Astellas Pharma’s Izervay. The code for iDose takes effect July 1, 2024, while ...
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