4D Molecular presents interim data from intravitreal 4D-150 Phase 1/2 trial

4D Molecular Therapeutics announced additional interim clinical data from the Phase 1 Dose Exploration stage of the 4D-150 Phase 1/2 PRISM clinical trial for patients with wet age-related macular degeneration, or wet AMD. The data were presented at the 2023 American Society of Retinal Specialists Annual Meeting in Seattle, Washington. 4D-150 is a potentially transformative genetic medicine that utilizes 4DMT’s evolved and customized retinotropic R100 vector, while targeting four VEGF family members. 4D-150 is being developed as a single dose, routine outpatient intravitreal therapy with the goal of reducing treatment burden and maintaining efficacy in patients with wet AMD and diabetic macular edema. 15 patients received a single intravitreal dose of 4D-150 across three dose cohorts. Enrolled participants had a high need for anti-VEGF therapy, with mean annualized injection rates ranging from 8 to 11 across cohorts prior to 4D-150 treatment As of the data cutoff date of July 3, 2023, all patients had completed follow-up through at least 36 weeks. 4D-150 was well tolerated, with no reported Grade greater than or equal to1 inflammatory cells and no hypotony, dose-limiting toxicities, or treatment-related serious adverse events. All three doses demonstrated clinical activity in the study, with evidence of a dose response favoring the 3E10 vg/eye dose. Initial interim efficacy data from Phase 2 Dose Expansion is expected to be presented at a medical conference in the first half of 2024. The company expects to provide update regarding Phase 3 pivotal trial plans in Q1 2024 after initial discussion with FDA, which is anticipated in Q4 2023. Expects to enroll first patient in Phase 2 SPECTRA clinical trial for DME in Q3 2023. Program update for 4D-175 in geographic atrophy expected in Q4 2023.