4DMT Announces RMAT Designation Granted by FDA for 4D-150 for DME

4D Molecular Therapeutics announced that the FDA has granted Regenerative Medicine Advanced Therapy (RMAT) designation to 4D-150 for the treatment of diabetic macular edema (DME).

RMAT designation is part of the 21st Century Cures Act and was created to expedite the development and review of regenerative medicine therapies intended to treat, modify, reverse or cure a serious condition. Receiving RMAT designation offers sponsor companies all the benefits of the fast track and breakthrough therapy designation programs, allowing for early, close and frequent interactions with the FDA with the goal of expediting drug development.

“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, MD, cofounder and CEO 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.”