Eye Disease Focused 4D Molecular Therapeutics Lays Out 52-Week Results From Wet AMD Study

4D Molecular Therapeutics (FDMT), a clinical-stage biotherapeutics company, has presented positive initial interim 52-week data from the Phase 2b Population Extension cohort of the PRISM clinical trial evaluating 4D-150 in a broad wet age-related macular degeneration (wet AMD) patient population. The data, presented by Dante Pieramici, M.D., in an oral presentation titled "Phase 2b Population Extension Cohort Evaluating 4D-150 in Neovascular Age-Related Macular Degeneration: 52-Week Results" at Angiogenesis, Exudation, and Degeneration 2025, demonstrated the potential of 4D-150 to significantly reduce the treatment burden for wet AMD patients while maintaining or even improving their vision over time.



The 52-week data showed that 4D-150, at the planned Phase 3 dose of 3E10 vg/eye, achieved an 83% reduction in injection burden compared to projected on-label aflibercept 2 mg Q8W. This resulted in 70% of patients requiring 0-1 supplemental injection and 57% being injection-free. Additionally, the recently diagnosed subgroup showed even more promising results, with 87% requiring 0-1 supplemental injection and 80% being injection-free. These results indicate that 4D-150 has the potential to significantly reduce the treatment burden for wet AMD patients, which could lead to improved patient outcomes and quality of life.

The study also showed that 4D-150 led to improved and maintained best corrected visual acuity (BCVA) of +2.2 letters in the broad wet AMD disease activity group and +3.1 letters in the recently diagnosed subgroup. This suggests that the treatment not only reduces the need for frequent injections but also helps maintain or even improve patients' vision over time. Furthermore, the data demonstrated durable central subfield thickness (CST) improvement with fewer fluctuations, as measured by optical coherence tomography (OCT), in both the broad wet AMD disease activity group (-11 µm) and the recently diagnosed subgroup (-10 µm). This indicates that 4D-150 can provide long-lasting control of the disease, further reducing the need for frequent treatments.



The positive results from the Wet AMD study suggest that 4D-150 has the potential to become a competitive treatment option for wet AMD, offering a more convenient and effective alternative to current standard of care treatments. The company's competitive landscape may shift as 4DMT continues to develop and commercialize 4D-150, potentially challenging established players in the wet AMD market, such as Regeneron (Eylea/aflibercept), Roche (Lucentis/ranibizumab), and Novartis (Avastin/bevacizumab).



In conclusion, the 52-week results from the Wet AMD study demonstrate the potential of 4D-150 to revolutionize the treatment of wet AMD and other vascular retinal diseases. This, in turn, enhances the long-term investment potential of 4D Molecular Therapeutics by addressing a significant unmet need in the market and potentially expanding the company's product pipeline. As the company continues to develop and commercialize 4D-150, it may challenge established players in the wet AMD market and potentially capture a significant share of the market.