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The phase 3 4FRONT-1 study compares 4D-150, an investigational gene therapy, against aflibercept 2 mg in treatment-naïve patients.
The phase 3 4FRONT-1 study compares 4D-150, an investigational gene therapy, against aflibercept 2 mg in treatment-naïve patients.
4D Molecular Therapeutics announced that enrollment has been completed for 4FRONT-1 , a phase 3 clinical trial evaluating its investigational gene therapy, 4D-150, in patients with wet age-related macular degeneration. The multicenter, randomized, double-masked study enrolled treatment-naïve patients at more than 100 sites across North America and was completed in approximately 11 months, according to the company.
4FRONT-1 is comparing a single intravitreal injection of 4D-150 with aflibercept 2 mg (Eylea; Regeneron) administered every 8 weeks. The primary endpoint is noninferiority in mean change from baseline in best-corrected visual acuity at 52 weeks. A key secondary endpoint is reduction in treatment burden, measured by the number of aflibercept injections required in the 4D-150 arm compared with the control arm. Patients in both groups may receive supplemental aflibercept as needed.
The trial is part of a broader registrational program that includes a second phase 3 study, 4FRONT-2 , which is enrolling both treatment-naïve and recently diagnosed treatment-experienced patients globally. Enrollment for 4FRONT-2 is expected to conclude in the second half of 2026.
4D-150 uses an intravitreal adeno-associated virus vector to deliver genes encoding aflibercept and an anti–VEGF-C component, with the goal of providing sustained intraocular anti-VEGF expression. Top-line data from 4FRONT-1 are expected in the first half of 2027, the company said in a press release. RP