AMD

Q1 2026 eye-care roundup: first dual-agent presbyopia drop, new EDOF IOL, wet AMD phase 3 win, and gene-therapy advances.Major ophthalmic events in the first quarter of 2026 included treatments for presbyopia, age-related macular degeneration (AMD), dry eye, glaucoma, corneal dystrophy, geographic atrophy, and a new intraocular lens (IOL), among others.1 Key FDA approvals & regulatory actions during Q1 2026) Yuvezzi 2.75%/0.1% (carbachol/brimonidine, Tenpoint Therapeutics Ltd.) was approved as the first dual-agent eye drop designed to treat presbyopia in adults. The dual actions include improving the near vision without decreasing the distance vision.2 TECNIS PureSee intraocular lens (IOL). On March 12, 2026, Johnson & Johnson announced that the FDA approved the TECNIS PureSee extended-depth-of-focus IOL for cataract surgery.3 The launch is planned for later in the year. A full 97% of patients implanted with the IOL reported having no “very bothersome visual disturbances,” according to the company. GEB-101: GenEditBio received Investigational New Drug (IND) clearance to start an in vivo gene-editing trial targeting TGFBI corneal dystrophy in January 2026. This allowed the initiation of the phase 1/2 CLARITY trial to evaluate the safety and efficacy of the CRISPR-based gene therapy for corneal dystrophy associated with the TGFB1 gene.4 OPGx-BEST1: Opus Genetics reported positive initial phase 1/2 data for OPGx-BEST1 to treat Best vitelliform macular dystrophy and autosomal recessive Bestrophinopathy on February 27, 2026. The data showed that the first patient tolerated the drug well with no serious adverse effects. The 3-month results showed a 12-letter increase in visual acuity and decreased central subfield thickness.5 Axpaxli/Duravyu (axitinib/vorolanib). Ocular Therapeutix reported topline data from the phase 3 SOL-1 trial of Axpaxli/Duravyu (axitinib/vorolanib) for wet age-related macular degeneration (AMD) on February 17, 2026.6 The study met its primary endpoint, with 74.1% of patients treated with Axpaxli maintaining vision at week 36 compared to 65.9% in the control (aflibercept, Eylea, Regeneron Pharmaceuticals) group, according to the report. Axpaxli showed superiority over a 2-mg dose of aflibercept, though the magnitude of the benefit was lower than some investors expected, according to eyewire. Geographic atrophy (GA). Ocugen Inc. released its phase 2 data for OCU410 (AAV5-RORA), a subretinal gene therapy for GA secondary to dry AMD, on January 15, 2026.7 The data showed positive preliminary results at the 12-month timepoint. The key results, according to the company, were a 46% decrease in lesion growth (medium + high dose) compared to the control, with a 50% responder rate, demonstrating significant potential for treating this. In addition, the full data set was released on March 24. The key takeaways were as follows: Medium-dose OCU410 met the 12-month primary endpoint, reducing GA lesion growth by 31% in baseline lesions 2-17.5mm², and by 33% in subgroup lesions 5-17.5mm². Structural biomarkers aligned with disease-modifying activity, including 27% slower ellipsoid zone loss and 55% of treated patients achieving ≥30% lesion-growth reduction relative to control. Pipeline Update Reproxalap (Aldeyra Therapeutics) received a third complete response letter for reproxalap.8 The FDA concluded that the New Drug Application lacked substantial evidence of efficacy for dry eye signs and symptoms despite no safety/manufacturing deficiencies. Triesence (Harrow) received IND clearance for a phase 3 trial. The drug is used to better visualize the vitreous intraoperatively. NTX-1024 (NexEos Bio) obtained Orphan Drug Designation for NTX-1024 to treat a protein involved in vernal keratoconjunctivitis. References Charters L. Ophthalmology pipeline watch: Key trial results and PDUFA dates for Q1 2026. Ophthalmology Times.https://www.ophthalmologytimes.com/view/ophthalmology-pipeline-watch-key-trial-results-and-pdufa-dates-for-q1-2026#:~:text=Key%20Takeaways,a%20particular%20focus%20of%20ophthalmologists. Ernst D. Presbyopia. Ophthalmology Advisor. https://www.ophthalmologyadvisor.com/news/yuvezzi-approved-as-once-daily-combination-therapy-for-presbyopia/#:~:text=The%20most%20common%20adverse%20reactions,the%20second%20quarter%20of%202026.&text=References:,.yuvezzi.com/pi. Johnson & Johnson. https://www.jnj.com/media-center/press-releases/johnson-johnson-announces-fda-approval-of-tecnis-puresee-intraocular-lens-a-breakthrough-solution-for-u-s-cataract-patients FDA Clears IND for GenEditBio’s GEB-101 in TGFBI corneal dystrophy. Ophthalmology Management.https://ophthalmologymanagement.com/news/2026/fda-clears-ind-for-geneditbios-geb101-in-tgfbi-corneal-dystrophy#:~:text=FDA%20Clears%20IND%20for%20GenEditBio's,and%20deposits%20in%20the%20cornea. Opus Genetics.Announces Initial Clinical Data from Phase 1/2 OPGx-BEST1 Gene Therapy Study at the Macula Society Annual Meeting. https://ir.opusgtx.com/press-releases/detail/520/opus-genetics-announces-initial-clinical-data-from-phase-12-opgx-best1-gene-therapy-study-at-the-macula-society-annual-meeting#:~:text=Opus%20Genetics%20Announces%20Initial%20Clinical,%2C%20in%20San%20Diego%2C%20California. Ocular Therapeutix Announces Positive Phase 3 SOL-1 Results Demonstrating Superiority of Axpaxli in Wet AMD. https://eyewire.news/news/ocular-therapeutix-announces-positive-phase-3-sol-1-results-demonstrating-superiority-of-axpaxli-in-wet-amd?c4src=article:infinite-scroll Ocugen announces positive preliminary phase 2 data from ocu410 modifier gene therapy for geographic atrophy secondary to dry age-related macular degeneration. https://ir.ocugen.com/news-releases/news-release-details/ocugen-announces-positive-preliminary-phase-2-data-ocu410/#:~:text=Phase%202%20data%20from%20the%20ArMaDa%20clinical,Phase%201%20and%20Phase%202%20clinical%20trials. Harp MD. Aldeyra receives third complete response letter for reproxalap. Ophthalmology Times. March 17, 2026. https://www.ophthalmologytimes.com/view/aldeyra-receives-third-complete-response-letter-from-the-fda-for-reproxalap-and-the-treatment-of-dry-eye-disease

The letter noted the FDA is unable to approve the application for ONS-5010/LYTENAVA (bevacizumab-vikg) in its current form for the treatment of wet AMD, according to the company.

The Portal extension trial reveals that the Port Delivery System significantly improves vision in AMD patients, showcasing long-term efficacy and durability.

New treatments show promise in preventing fibrosis in neovascular AMD, addressing a critical need for improved visual outcomes in patients.

The company noted that this approval marks Celltrion's first Health Canada-approved biologic product in ophthalmology.

The investigators noted that this report is the first about subretinal drusenoid deposits in Black and Hispanic patients with age-related macular degeneration

Patient response focused on perceived vision-related quality of life outcomes, investigators said

The newly-approved technology delivers low-dose microcurrents through closed eyelids to stimulate retinal cells

Alteogen received a positive CHMP opinion for EYLUXVI in July 2025

Presentation topics will include therapies for age-related macular degeneration, X-linked retinitis pigmentosa and other retinal pathologies

An understanding of GA growth kinetics is key to addressing the pathophysiology of age-related macular degeneration

AMD treatment may become unrecognisable as gene therapies evolve

New financing will support the company's lead retinitis pigmentosa programme, among other projects

According to the company, the EMA’s opinion was based on the “totality of evidence comprising a comprehensive analytical, non-clinical and clinical data package”

Health Canada approves Aflivu, a biosimilar for retinal diseases, enhancing treatment options and affordability for Canadian patients.

Investigators obtained data from genome‐wide association studies to examine the effects of instant coffee consumption

Robyn Guymer, AM, MBBS, PhD, FRANZCO, FAHMS, presented two studies involving the EZ line at this year’s International SPECTRALIS Symposium

Brazilian ANVISA has granted marketing authorisation for FYB201 (Ranivisio), a biosimilar to Lucentis.

Long-term benefits and vision preservation using an extended macular vision IOL

Three dose level cohorts of the small interfering RNA therapeutic were evaluated in a double-blind study

Investigators sought to understand the diagnostic path, symptoms, quality of life impact and coping mechanisms of patients with GA in western Europe and the United States

The phase 3 LUCERNE and TENAYA trials suggested that faricimab may allow clinicians to extend the interval between injections to up to 16 weeks after an initial loading phase

In an established animal model of age-related macular degeneration, Eleva’s recombinant human CPV-104 improved two hallmarks of the disease

Bangalore-based Eyestem will share more research findings on Eyecyte-RPE at this year's Association for Research in Vision and Ophthalmology meeting