4D Molecular Therapeutics Announces Positive AAV Gene Therapy Data for Diabetic Macular Edema

EMERYVILLE, Calif., July 31, 2025 (GLOBE NEWSWIRE) — 4D Molecular Therapeutics (4DMT) has announced positive interim results from its SPECTRA Phase 2a clinical trial for 4D-150, an AAV gene therapy for diabetic macular edema (DME). The company also reported that it has aligned with the European Medicines Agency (EMA) on a streamlined registrational pathway for this AAV approach.

The SPECTRA trial data on the AAV-based therapy, which covered a 60-week period, demonstrated that 4D-150 was well tolerated with no intraocular inflammation or other serious adverse events. At the Phase 3 dose, patients showed a sustained gain of +9.7 letters in best corrected visual acuity (BCVA) and a reduction in central subfield thickness of -174 µm.

A key finding of the AAV trial was the significant reduction in treatment burden. Patients at the Phase 3 dose required an average of only 1.6 supplemental injections over the 60 weeks, representing a 78% reduction compared to the projected 7.0 injections for the standard-of-care aflibercept.

According to Dr. David Kirn, CEO of 4DMT, the consistent safety and efficacy data across both DME and wet AMD trials for this AAV therapeutic reinforces the belief that 4D-150 has the potential to become a backbone therapy. The alignment with both the FDA and EMA for a single Phase 3 trial for this AAV therapy provides a clear and accelerated path for its approval.

4D-150 is an investigational therapy designed to be a backbone treatment for patients with wet AMD and DME. With a single, safe intravitreal injection, the therapy provides multi-year sustained delivery of anti-VEGF proteins (including aflibercept). The therapy utilizes the company’s customized R100 vector, which was developed through its proprietary Therapeutic Vector Evolution platform, with the ultimate goal of freeing patients from burdensome, frequent injections while preserving their vision.