Cataract & Refractive

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

According to the manufacturer, TECNIS PureSee is the first US EDOF IOL approved by the FDA with no warning on contrast sensitivity.

The 3rd Winterthur Ophthalmology Symposium in Winterthur, Switzerland, on 12–13 March 2026 will feature plenary talks, hands-on workshops, satellite sessions, poster presentations, and a gala honoring the Otto Haab Medal.

The certification supports continued European market access as the Medical Device Regulation imposes stricter requirements on manufacturers.

Phakic IOLs deliver a “wow” factor to refractive surgery patients, says Matteo Piovella, MD

Clinicians must assume responsibility for this common surgical concern

The satellite of the US-based University of Miami Health System will offer a “full spectrum of ophthalmic services” in the United Arab Emirates

A recently-updated textbook details major developments in therapeutic and cosmetic keratopigmentation, including superficial and intrastromal techniques

The full range of vision lens debuted at the 2025 ESCRS meeting in Copenhagen

Research finding challenge the widely-held notion that cosmetic contact lenses are the safest technique for changing eye colour

The procurement follows an 18-month pilot at a high-volume surgery in Dundee, Scotland

At the ESCRS meeting, cataract surgeons can get familiar with BVI's Virtuoso platform and VirtuaLens' immersive VR IOL simulator

Alcon, Bausch + Lomb and Johnson & Johnson will debut new research findings during the European Society of Cataract and Refractive Surgeons Congress in Copenhagen, Denmark

New support offers a streamlined experience for surgeons and patients

The transaction is anticipated to close in 6 to 12 months subject to customary closing conditions and regulatory approval

Frank Kerkhoff, MD, shares his experiences with the Johnson & Johnson Tecnis Odyssey lens

Researchers at the Korea Advanced Institute of Science and Technology demonstrated the next-generation strategy for sustainable synthesis

Alcon's Clareon Panoptix Pro IOL enhances cataract surgery with advanced light utilization and low visual disturbance.

The trifocal IOL is designed to deliver lower light scatter and higher-reported light utilisation

SpaMedica to offer free transport for all NHS cataract patients, supporting community care and reducing health inequalities.

A new functional classification can help achieve precise vision goals

Johann Krüger, MD, shares insights from 26 years of experience

The Tecnis Odyssey, launched in the US in October 2024, is now available in Europe, the Middle East and Canada