4D Molecular to host 4D-150 Wet AMD Development Day

4D Molecular Therapeutics announced that the Company will host a 4D-150 Wet AMD Development Day on September 18, 2024 at 4:15 p.m. ET. The 4D-150 Wet AMD Development Day agenda will feature presentations, KOL panel discussions and live Q&A with senior ophthalmology Company leadership, including Robert Kim, M.D., Dhaval Desai, Pharm.D., Chris Simms and Carlos Quezada-Ruiz, M.D., FASRS and retinal disease KOLs Arshad M. Khanani, M.D., M.A., FASRS, Carl D. Regillo, M.D., FACS, FASRS and Dante Pieramici, M.D. The agenda will include presentations on: Overview of 4D-150 Phase 1/2 Development Strategy in Wet AMD to Date: Rationale for clinical trial design and treatment cohorts; Phase 1/2a Study Design; Primary Objectives: Demonstrate safety profile, evidence of biological activity and selection of Phase 2b doses; Patient Population: Severe disease activity, high treatment burden and generally long disease duration; Aflibercept loading dose regimen design: Given heavy pre-treatment of patients on study, single loading dose given at Week -1; Phase 2b Study Design; Primary Objective: Confirm safety & evidence of biological activity in broad patient population, select Phase 3 dose and patient population to maximize probability of technical, regulatory and commercial success; Patient Population: Broad range of disease activity, prior treatment burden and disease duration; Aflibercept loading dose design: Given only 1 prior injection required, loading doses given at weeks -1 & 4 to ensure all patients receive 3 total loading injections per standard of care, and to maintain patient safety during ramp up of aflibercept transgene expression over 8-12 weeks; Expected Data Presentation & Analyses: Presentation of interim longest available follow-up data for below cohorts and dose levels from PRISM based on August 26, 2024 data cutoff; Follow-up Duration; Phase 1/2a, range of follow-up: 52 weeks to 2.5 years; Phase 2b, range of follow-up: 32 to 52 weeks; Efficacy Data; Supplemental aflibercept injections; Best Corrected Visual Acuity; Central Subfield Thickness; Subgroup analyses based on: CST less than600 mum; Disease duration; Number of prior injections; Approximate target Phase 3 population. Safety Data; Review of 4FRONT Wet AMD Phase 3 Program Objectives, Strategy and Final Design