Q1 2026 happenings in ophthalmology: Major highlights

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 (axitinib hydrogel, also known as OTX-TKI). Ocular Therapeutix reported topline data from the phase 3 SOL-1 trial of Axpaxli (axitinib hydrogel) 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 group on aflibercept (Eylea, Regeneron Pharmaceuticals), 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

1. 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.

2. 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.

3. 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

4. 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.

5. 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.

6. 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

7. 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.

8. 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