4D Molecular announces RMAT designation granted by FDA for 4D-150 for DME

4D Molecular (FDMT) Therapeutics announced that the U.S. Food and Drug Administration has granted the Regenerative Medicine Advanced Therapy, RMAT, designation to 4D-150 for the treatment of diabetic macular edema, DME. “This milestone validates the potential of 4D-150 to address the significant unmet needs of patients with DME, a second large market retinal vascular disease indication after wet age-related macular degeneration” said David Kirn, M.D., Co-founder and Chief Executive Officer of 4DMT. “The RMAT designation is based on the review of our results to-date from our ongoing 4D-150 SPECTRA DME study, underscoring the potential of 4D-150 to sustain visual acuity improvements while dramatically reducing treatment burden for patients. This designation in DME follows the RMAT designation granted for 4D-150 in wet AMD, and to our knowledge, 4D-150 is the first investigational medicine to be granted the designation in both indications. We look forward to continuing our ongoing collaboration with the FDA to advance 4D-150 into Phase 3 development with an aligned-upon single Phase 3 trial for approval in DME, combined with our two wet AMD 4FRONT Phase 3 clinical trials.”