AMD

Rare retinal diseases initially were the primary targets of gene therapy, but that is no longer the case. The focus has expanded beyond those to also include more common, chronic diseases such as diabetic macular edema and wet age-related macular degeneration. During the first half of 2026, that trend was evident.

Offline smartphone AI fundus screening detects diabetic retinopathy, glaucoma, and macular degeneration in one capture, delivering high accuracy for low-resource eye care.

The trial over-enrolled and finished approximately 4 months ahead of initial projections, with 52-week topline data now expected in the second half of 2027.

The resubmission is considered a Class 1 submission and has a current PDUFA target action date of July 29, 2026.

Three-year gene therapy data, an FDA reversal in wet AMD, light-powered dry eye treatment, a new macular supplement, and progress in childhood glaucoma—our review breaks down the 5 May 2026 stories that matter.

Finding satisfaction in ocular research—considerations about AI and enhanced datasets.

Samsung Bioepis launched Opuviz, an aflibercept biosimilar, in Europe for wet AMD, DME, retinal vein occlusion, and myopic CNV.

The resubmission follows a successful appeal by the company with the Office of New Drugs (OND).

The FDA's OND found substantial evidence of effectiveness for bevacizumab-vikg in nAMD, clearing the way for a BLA resubmission in June 2026 and a decision expected within 60 days.

Bausch + Lomb's PreserVision AREDS3 combines the established AREDS2 micronutrient formula with a B-vitamin complex.

Sunil S. Patel, MD, PhD, of the University of Texas Southwestern Medical Center, breaks down QA102's first-in-class mechanism targeting harmful gut bacteria and retinal inflammation, what the phase 2 drusen volume and GA growth rate data reveal about the therapy's potential, and what a phase 3 program must address to bring an oral AMD treatment to patients without options.

Avacincaptad pegol may help preserve driving-related vision in geographic atrophy, but post hoc data did not reach statistical significance.

Oral QA102 shows imaging signals slowing drusen and GA progression in intermediate dry AMD at ARVO 2026, despite missing its primary end point.

Researchers noted growing evidence supporting an additional role for B vitamins.

New SOL-X extension follows AXPAXLI implant in wet AMD for 3 years, probing 24-week dosing durability, safety and vision protection.

SOL-1 data show AXPAXLI extends wet AMD control, delaying fluid rebound and reducing rescue injections while sustaining vision through 52 weeks.

MALBEC (NCT07440225) is a randomized, double-masked trial evaluating the safety and efficacy of MK-8748 at 2 dose levels versus control (aflibercept 2mg).

Regeneron announced that the FDA has amended the EYLEA HD label after the approval, adding 96-week results from the PULSAR wAMD trial and the PHOTON DME trial.

In the JADE trial, OLN324 demonstrated numerically greater visual acuity gains and evidence of sustained retinal drying with fewer retreatments during a treatment-free follow-up period, compared with faricimab.

Q1 2026 eye-care roundup: first dual-agent presbyopia drop, new EDOF IOL, wet AMD phase 3 win, and gene-therapy advances.

The trial, sponsored by ONL Therapeutics, aims to enroll approximately 324 patients across sites in Europe, the United States, and Canada.

The phase 2a study looks at retinal vascular diseases, including wet age-related macular degeneration (wet AMD), diabetic macular edema (DME), and retinal vein occlusion (RVO).

The trials are evaluating DURAVYU (vorolanib intravitreal insert) for the treatment of diabetic macular edema (DME).

Study finds low-vision rehab boosts daily function and quality of life, but exposes gaps in long-term data and diverse research.

Real-world nAMD/DME care highlights durable anti-VEGF options and emerging TKIs and gene therapy to cut injection burden, improve vision, and reduce fluid.