The FDA granted regenerative medicine advanced therapy designation to 4D-150 for the treatment of diabetic macular edema, according to a press release from 4D Molecular Therapeutics.
The gene therapy is designed to offer sustained delivery of anti-VEGF (aflibercept and anti-VEGF-C) with a single intravitreal injection. The regenerative medicine advanced therapy (RMAT) designation is granted with the intent of expediting the development and review of therapies, offering sponsor companies the benefits of fast track and breakthrough therapy designations, the release said.
The designation was