4D Molecular Therapeutics has completed enrollment for the 4FRONT-1 phase 3 trial evaluating 4D-150 in patients with wet AMD. The trial is overenrolled and is expected to exceed 500 patients randomly assigned to the study drug or aflibercept 2 mg (Eylea, Regeneron) every 8 weeks.
“For far too long, wet AMD patients have faced the burden of relentless, lifelong repeated bolus injections and vision loss,” said Julie Clark, MD, chief medical officer of 4DMT. “Our vision is to fundamentally shift that paradigm, to bring forward a potential backbone therapy that meaningfully reduces treatment burden while sustaining vision outcomes. The rapid enrollment completion, driven by the enthusiasm for 4D-150 and data generated to date, energizes our entire organization as we work relentlessly toward completing global enrollment in 4FRONT-2 and prepare for topline data in H1 2027 from 4FRONT-1. I want to thank all our sites, study coordinators, and patients for their partnership and trust as we work toward our goal to drive a new standard of care for wet AMD.”
4FRONT-1 is a phase 3 multicenter, randomized, double-masked, comparator-controlled study of intravitreal 4D-150 in wet AMD. The primary endpoint is noninferiority in the mean change from baseline in BCVA at 52 weeks; the key secondary endpoint is the reduction in treatment burden. 4FRONT-1 is evaluating treatment-naïve wet AMD patients at sites in North America. Topline data is expected in the first half of 2027.
A second, identically designed, global phase 3 trial for wet AMD, 4FRONT-2, is enrolling both treatment-naïve and recently diagnosed treatment-experienced wet AMD patients. 4FRONT-2 is expected to complete enrollment in the second half of 2026 with topline data expected in the second half of 2027.
Learn more at www.4DMT.com.