4DMT Receives EMA Priority Medicines (PRIME) Designation for 4D-150 Clinical-Stage Genetic Medicine for Treatment of Wet AMD

• The European Medicines Agency’s priority medicines status is granted to drug candidates that may offer a major therapeutic advantage over existing treatments or benefit patients without treatment options
  

• 4D-150 combines a novel, targeted intravitreal next generation AAV vector with a dual transgene that inhibits four VEGF pathway targets (VEGF A, B, C, and PlGF) in wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME)
• Designation follows positive interim Phase 1 PRISM clinical data for 4D-150 that demonstrated an encouraging safety, tolerability and clinical activity profile; 4D-150 has the potential to address an unmet medical need to maintain long term visual acuity outcomes while avoiding the need for repeated intravitreal injections
• Interim clinical data from randomized Phase 2 PRISM Dose Expansion clinical trial in highest anti-VEGF need patients (n=50) to be released in early 2024

EMERYVILLE, Calif., Oct. 23, 2023 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics (Nasdaq: FDMT, 4DMT or the Company), a clinical-stage biotherapeutics company with three novel, highly targeted next generation AAV vectors currently in the clinic, today 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 (wet AMD).

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. 4D-150 has the potential to address an unmet medical need to maintain long term visual acuity outcomes while avoiding the need for repeated intravitreal injections.

“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.”