4D Molecular Therapeutics announced on May 1, 2025, that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to 4D-150 for the treatment of diabetic macular edema (DME). This designation follows a previous RMAT grant for 4D-150 in wet age-related macular degeneration (wet AMD), making it the first investigational medicine to receive this designation in both indications.
The RMAT designation is based on a review of results from the ongoing 4D-150 SPECTRA DME study, which underscored the therapy's potential to sustain visual acuity improvements while significantly reducing treatment burden for patients. This regulatory status provides all the benefits of the fast track and breakthrough therapy designation programs, facilitating early and frequent interactions with the FDA.
Furthermore, 4DMT confirmed alignment with both the FDA and the European Medicines Agency (EMA) on a single Phase 3 clinical trial for 4D-150 in DME to support approval. This streamlined regulatory pathway, combined with the RMAT designation, is expected to accelerate the development and potential market entry of 4D-150 for millions of patients globally suffering from DME.
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