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

The U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to 4D Molecular Therapeutics' gene therapy candidate 4D-150 for the treatment of diabetic macular edema (DME), following promising results from the ongoing SPECTRA study. This designation is designed to expedite the development and review of therapies for serious conditions and provides benefits similar to fast track and breakthrough therapy programs, including more frequent FDA engagement. 4D-150 aims to deliver multi-year sustained anti-VEGF treatment with a single intravitreal injection, potentially addressing the high treatment burden for patients with DME and wet age-related macular degeneration (AMD). Notably, 4D-150 is reportedly the first investigational medicine to receive RMAT designation for both DME and wet AMD. The company plans to advance 4D-150 into phase 3 development for DME, alongside its ongoing phase 3 trials for wet AMD. The FDA's recognition underscores the therapy's potential to improve patient outcomes by sustaining visual acuity improvements and reducing the need for frequent injections.