On March 10, 2025, 4D Molecular Therapeutics announced a significant operational milestone with the enrollment of the first patients across multiple sites in its 4FRONT-1 Phase 3 clinical trial. This trial is evaluating 4D-150 for the treatment of wet age-related macular degeneration (wet AMD), marking the company's transition into a Phase 3 clinical-stage entity.
The 4FRONT-1 study is designed as a multicenter, randomized, double-masked, aflibercept 2 mg (Q8W) comparator-controlled trial. Its primary endpoint is non-inferiority in the mean change from baseline in best corrected visual acuity (BCVA) at 52 weeks, with a key secondary endpoint focusing on treatment burden reduction.
The company also stated that its second Phase 3 trial for wet AMD, 4FRONT-2, which has an identical design, is expected to initiate in the third quarter of 2025. Topline primary endpoint data from both 4FRONT-1 and 4FRONT-2 are anticipated in the second half of 2027, providing a clear timeline for potential regulatory submissions and commercialization.
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