4D Molecular begins enrollment in Phase 2 DME trial, expands Phase 2 AMD trial

4D Molecular announced that the first patient has been enrolled in the Dose Confirmation stage of the Phase 2 SPECTRA clinical trial evaluating intravitreal 4D-150 in patients with diabetic macular edema or DME, and that a Population Extension cohort has been added to the 4D-150 Phase 2 stage of the PRISM Clinical Trial in wet age-related macular degeneration, or wet AMD. The Phase 2 SPECTRA clinical trial for DME has a primary endpoint of annualized number of aflibercept injections in study eye, with additional endpoints which include incidence and severity of adverse events, changes from baseline in best-corrected visual acuity and central subfield thickness, and percentage of subjects with a greater than or equal to and greater than or equal to Step Diabetic Retinopathy Severity improvement from baseline. PRISM Phase 2 Dose Expansion ) initial interim data is expected in H1 2024, and an update regarding Phase 3 pivotal trial plans for wet AMD is expected in Q1 2024 following initial discussion with FDA in Q4 2023. Initial interim data from the 4D-150 DME Phase 2 Dose Confirmation stage is expected in 2024 and initial interim data from 4D-150 wet AMD Population Extension cohort is expected in 2024.