4D Molecular Therapeutics' 4D-150 maintained disease control for two years after a single injection in wet AMD, backing its Phase 3 development.
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4D Molecular Therapeutics (FDMT) presented two-year data from the Phase 2b PRISM trial showing that a single injection of its gene therapy candidate 4D-150 maintained disease control in wet age-related macular degeneration patients. The results were released Monday at the American Society of Retina Specialists meeting, covering the dose-confirmation cohort through a May 18 data cutoff.
4D-150 uses a custom AAV vector to deliver two anti-VEGF biologics, aflibercept and an anti-VEGF-C agent, directly to the retina. Current treatments require injections every four to eight weeks for Regeneron's Eylea and up to 16 weeks for Roche's Vabysmo. 4D-150 aims for multi-year control from a single injection.
Wet AMD affects roughly 4 million people across the U.S. and Europe, with significant additional cases in Japan. About 200,000 new U.S. cases appear each year. Abnormal blood vessels grow under the macula and leak, damaging central vision without treatment.
The Phase 3 pivotal trial for 4D-150 in wet AMD is enrolling patients, the company said. A second study in diabetic macular edema is also underway. 4D Molecular Therapeutics' other pipeline candidate, 4D-710, is being tested in cystic fibrosis.
No new safety signals emerged in the two-year data, according to the company. The treatment was well tolerated across the cohort.
Competitors are pushing toward longer dosing intervals. Regeneron's high-dose Eylea HD has shown durability out to 16 weeks, and Roche's faricimab already covers that interval for a subset of patients. 4D-150's goal of multi-year coverage would, if confirmed in Phase 3, offer a substantially different treatment profile.
The Phase 3 trial is actively recruiting patients.
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