4D Molecular receives EMA PRIME designation for 4D-150

4D Molecular Therapeutics announced that the European Medicines Agency, EMA, has granted Priority Medicine, PRIME, designation for the investigational genetic medicine candidate 4D-150 for intravitreal treatment of wet age-related macular degeneration. PRIME designation is granted by the EMA to enhance support for the development of medicines that target an unmet medical need and offers the opportunity to accelerate review of the marketing applications to bring such medicines to patients sooner. The designation follows positive interim Phase 1 PRISM clinical data for 4D-150 that demonstrated an encouraging safety, tolerability and clinical activity profile. “We are thrilled that the EMA has awarded PRIME designation to intravitreal 4D-150,” said David Kirn, M.D., Co-founder and Chief Executive Officer of 4DMT. “We believe this designation, which is only awarded to one-quarter of applications, validates the promising clinical data to date with 4D-150 in wet AMD patients and the potential to offer major therapeutic advantages over existing treatments. We are efficiently advancing 4D-150 development for treatment of both wet AMD and DME patients, both of which represent large market opportunities. This designation enables enhanced support from the EMA and provides the potential for expedited regulatory review.”