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

According to the company, 4D-150 is a potential backbone therapy that is designed to provide multi-year sustained delivery of anti-VEGF (aflibercept and anti-VEGF-C) from the retina with a single, safe, intravitreal injection. 4D-150 utilizes the company's customized intravitreal vector, R100, which was invented at 4DMT through its proprietary Therapeutic Vector Evolution platform. The company said that 4D-150 is being developed for wet AMD and 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 (wet AMD),” said David Kirn, MD, co-founder and chief executive officer of 4DMT, in a company press release. “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.”