FDA Grants RMAT Designation to 4DMT’s 4D-150 for Diabetic Macular Edema

EMERYVILLE, Calif. – May 1, 2025 (GLOBE NEWSWIRE) — 4D Molecular Therapeutics (Nasdaq: FDMT), a late-stage biotechnology company focused on developing durable and targeted therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has granted the Regenerative Medicine Advanced Therapy (RMAT) designation to its investigational gene therapy, 4D-150, for the treatment of diabetic macular edema (DME).

“This RMAT designation underscores the significant potential of 4D-150 to address the substantial unmet needs of individuals living with DME, a major retinal vascular disease following wet AMD,” stated Dr. David Kirn, Co-founder and Chief Executive Officer of 4DMT. “This recognition by the FDA is based on our promising interim data from the ongoing 4D-150 SPECTRA DME study, highlighting its potential to provide sustained visual acuity improvements while significantly reducing the burden of frequent injections for patients. Notably, 4D-150 has now received RMAT designation for both DME and wet AMD, making it, to our knowledge, the first investigational medicine to achieve this distinction in both indications. We are eager to continue our close collaboration with the FDA to advance 4D-150 into Phase 3 development, with a single, aligned-upon Phase 3 trial planned for approval in DME, in conjunction with our two ongoing 4FRONT Phase 3 clinical trials for wet AMD.”

The RMAT designation, established under the 21st Century Cures Act, is designed to expedite the development and review of regenerative medicine therapies intended to treat, modify, reverse, or cure serious conditions. This designation provides sponsor companies with all the benefits of the fast track and breakthrough therapy designation programs, facilitating early, close, and frequent interactions with the FDA to accelerate the drug development process.

About 4D-150:

4D-150 is an investigational therapy designed to offer sustained, multi-year delivery of anti-VEGF agents (aflibercept and anti-VEGF-C) directly to the retina through a single, safe intravitreal injection. This innovative therapy utilizes 4DMT’s proprietary and evolved intravitreal vector, R100, developed through the Company’s Therapeutic Vector Evolution platform. 4D-150 is currently being evaluated for the treatment of both wet AMD and DME, conditions affecting millions worldwide, with the goal of freeing patients from the need for frequent and burdensome injections while preserving their vision.

About DME:

Diabetic macular edema (DME) is a serious complication of diabetic retinopathy and a prevalent cause of vision loss with significant unmet medical need and challenges in treatment adherence. Published data estimates approximately one million individuals in the U.S. are affected by DME. The condition is characterized by inflammation and swelling in the macula due to leakage from retinal blood vessels, which can lead to a decline in vision. The standard treatment for DME typically involves intravitreal injections of anti-VEGF agents administered every 4 to 12 weeks, a regimen that often leads to poor patient compliance and consequently, high unmet medical need.