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

4D-150 is being developed as a potential backbone therapy for retinal vascular diseases, designed to deliver sustained intravitreal expression of aflibercept and anti-VEGF-C with a single injection. The gene therapy uses 4DMT’s proprietary R100 vector, developed through its Therapeutic Vector Evolution platform, and is in development for both DME and wet age-related macular degeneration (wet AMD).

The RMAT designation was granted based on interim data from the ongoing SPECTRA phase 1/2 clinical trial in DME, which showed early signs of visual acuity improvement and reduced treatment burden. According to the company, 4D-150 is the first investigational gene therapy to receive RMAT designation for both DME and wet AMD. The designation is expected to support an accelerated regulatory pathway, including a single phase 3 trial for DME aligned with the company’s 2 ongoing 4FRONT phase 3 trials for wet AMD. RP