4DMT Announces First Patients Enrolled in 4FRONT-1 Phase 3 Clinical Trial Evaluating 4D-150 in Wet AMD

EMERYVILLE, Calif., March 10, 2025 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics (Nasdaq: FDMT, 4DMT or the Company), a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with potential to transform treatment paradigms and provide unprecedented benefits to patients, today announced that the first patients have been enrolled across multiple sites in the 4FRONT-1 Phase 3 clinical trial evaluating 4D-150 for the treatment of wet age-related macular degeneration (wet AMD).

"This is a historic moment for 4DMT as we become a Phase 3 company following our initiation of the 4FRONT-1 clinical trial,” said David Kirn, M.D., Co-founder and Chief Executive Officer of 4DMT. “4D-150 has the clear potential to address the greatest unmet needs for the millions of patients with wet AMD and DME: multi-year relief from frequent and burdensome injections into the eye and preservation of their eyesight. We believe the design of the 4FRONT Phase 3 trials, the design of 4D-150 itself and the compelling clinical data generated to date position us for a successful product approval and commercialization. As a result of our innovation, 4D-150 has the potential to become the established durable backbone therapy for these diseases and to fit seamlessly into clinical practice and economic models for retina physicians.”

4FRONT-1 is a Phase 3 multicenter, randomized, double-masked, aflibercept 2 mg (Q8W) 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 (BCVA) 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 naïve wet AMD patients at sites in North America. Our second Phase 3 trial for wet AMD, 4FRONT-2, has an identical design to 4FRONT-1 but will evaluate 4D-150 in both treatment naïve and recently diagnosed, treatment experienced wet AMD patients globally. 4FRONT-2 is expected to initiate in Q3 2025. Topline primary endpoint data from both trials is expected in the second half of 2027.