4DMT Completes Enrollment in Phase 3 4FRONT-1 Trial Evaluating 4D-150 in Wet Age-Related Macular Degeneration

4D Molecular Therapeutics (Nasdaq: FDMT) has completed enrollment in its 4FRONT-1 Phase 3 clinical trial assessing 4D-150 in patients with wet age-related macular degeneration (wet AMD), according to a company press release. Enrollment was completed in approximately 11 months and exceeded initial projections, with the number of randomized patients expected to surpass 500 across multiple sites in North America.

The 4FRONT-1 trial is a multicenter, randomized, double-masked study comparing intravitreal 4D-150 to aflibercept (2 mg every eight weeks) in treatment-naïve patients with wet AMD. The primary endpoint is non-inferiority in mean change from baseline in best-corrected visual acuity (BCVA) at 52 weeks. A key secondary endpoint measures differences in treatment burden, comparing the number of aflibercept injections received in the 4D-150 arm versus the aflibercept control arm over the same period.

Topline data from the 4FRONT-1 study are expected in the first half of 2027. Concurrently, global site activation for the second Phase 3 trial in the 4FRONT program, 4FRONT-2, continues. That study, which has an identical design except for including both treatment-naïve and recently diagnosed, treatment-experienced patients, is on track to complete enrollment by the second half of 2026, with topline data anticipated in the second half of 2027.

4D-150 is engineered to provide sustained delivery of anti-vascular endothelial growth factor (anti-VEGF) agents, including aflibercept and RNA-interference targeting VEGF-C, via a single intravitreal injection using 4DMT’s proprietary AAV vector platform. The aim of this gene therapy approach is to maintain long-term anti-VEGF expression in the retina, potentially reducing the frequency of injections required in standard wet AMD treatment.

The completion of enrollment in 4FRONT-1 represents a significant operational milestone for 4DMT and advances the clinical development of 4D-150 in a large, treatment-naïve wet AMD population. Future data releases from both Phase 3 trials will provide critical evidence for regulatory evaluation and potential clinical application in this prevalent form of macular degeneration.