4D Molecular (FDMT) Therapeutics announced enrollment completion for 4FRONT-1, the first Phase 3 clinical trial evaluating 4D-150 in patients with wet age-related macular degeneration. 4FRONT-1 is a Phase 3 multicenter, randomized, double-masked, aflibercept 2 mg comparator-controlled study of intravitreal 4D-150 in wet AMD. The primary endpoint is non-inferiority in the mean change from baseline in best corrected visual acuity at 52 weeks. The key secondary endpoint is treatment burden reduction comparing the number of aflibercept injections received in the 4D-150 arm versus the aflibercept comparator arm over 52 weeks. Patients in both arms will be eligible for supplemental aflibercept injections. 4FRONT-1 is evaluating treatment-naive wet AMD patients at sites in North America. Topline primary endpoint data from 4FRONT-1 is expected in H1 2027. The second Phase 3 for wet AMD, 4FRONT-2, is a global trial with an identical design to 4FRONT-1 except for enrolling both treatment-naive and recently diagnosed treatment-experienced wet AMD patients. 4FRONT-2 is expected to complete enrollment in H2 2026 with topline primary endpoint data expected in H2 2027.
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