4D-150 Advances in Phase 3 for Wet AMD as 4D Molecular Therapeutics Prepares DME Study

4D Molecular Therapeutics said 4D-150 is in Phase 3 for wet age-related macular degeneration and “soon to be in Phase 3” for diabetic macular edema. The company said enrollment in the wet AMD Phase 3 program has been “extremely rapid,” at roughly double its initial expectations, and cited upcoming catalysts including two-year follow-up data from a Phase 2 wet AMD study around mid-year and a first Phase 3 wet AMD readout in the first half of next year.

The company said the main unmet need in wet AMD remains longer durability for patients who currently receive repeated anti-VEGF injections into the eye. It estimated the current global market for bolus anti-VEGF therapies at roughly $17 billion and said existing products are effective but burdensome because patients must remain on frequent treatment to maintain vision. The company said recent launches such as Vabysmo and Eylea HD have shown commercial demand for incremental durability improvements, while 4D-150 is intended to offer a larger shift.

In a broader wet AMD population, the company said it observed about an 80% reduction in treatment burden through 18 months. Among patients most similar to the Phase 3 population, it said 4D-150 showed a 90% treatment burden reduction through 18 months, with more than 70% of patients injection-free over that period. In one of the hardest-to-treat wet AMD populations, patients receiving an average of eight to 10 injections per year and still failing therapy, the company said 4D-150 showed nearly an 80% reduction in treatment burden through two years, using patients as their own control.

The company said safety has been “extremely favorable,” with less than 3% of patients showing trace-to-one-plus cells at a single time point and no clinically meaningful inflammation. It said more than 400 patients have been treated with 4D-150 and that it has not reported serious adverse events or significant toxicity. It added that masked Phase 3 safety data are being monitored and that an independent data safety monitoring committee reviews the data every six months.

The company said it recently completed randomization in 4FRONT-1, its North American Phase 3 wet AMD trial, and is seeing similar enrollment momentum in 4FRONT-2. It said its base case for wet AMD remains filing with data from two studies, while it has alignment with the FDA and the European Medicines Agency on a single filing strategy for DME. The company also said 4D-150 is designed as an intravitreal therapy and expects it to fit into the existing buy-and-bill model used by retina practices.