4D Molecular Therapeutics (FDMT) Investor Day 2026 summary

Strategy and unmet need

• Episodic anti-VEGF treatment addresses chronic, variable disease; vision gains can decline, injection frequency can fall, and up to 40% of patients stop treatment by 12 months.

• 4D-150 uses an R100 capsid to deliver aflibercept and VEGF-C RNAi transgenes to the retina through a low-dose, in-office intravitreal injection.

• Positioned as a potential backbone therapy for continuous disease control and long-term vision preservation, with fewer injections and potential injection freedom.

Clinical evidence

• In the broad PRISM Phase 2b population, vision and retinal anatomy remained stable at 2 years; treatment burden fell 78%, and 46% of eyes needed no additional injections.

• In the recently diagnosed, Phase 3-comparable subgroup, vision and anatomy remained stable at 2 years; treatment burden fell 87%, and 66% of eyes were injection-free.

• At the Phase 3 dose, two eyes had mild inflammation that resolved with topical therapy; no further inflammation was reported through up to 4 years. No related serious adverse events were reported among 71 patients followed for 2–4+ years.

• PRISM results across severe, recalcitrant and broader populations informed Phase 3 dose selection and design; the presentation characterized the safety profile as favorable and predictable.

4FRONT Phase 3 program

• 4FRONT-1 and 4FRONT-2 randomized 523 and 531 patients, respectively, versus 480 planned per trial; each compares one 4D-150 injection with aflibercept 2 mg every 8 weeks after three loading doses.

• The primary endpoint is noninferiority in mean BCVA change from baseline at Week 52; global studies include treatment-naïve patients and up to 40% previously treated patients.

• Trial design selects active disease and aflibercept responders, excludes high baseline CST outliers, and uses supplemental aflibercept criteria intended to protect vision while demonstrating lower treatment burden.

• FDA RMAT and EMA PRIME designations support regulatory engagement; Japan PMDA interactions were also cited.

• 4FRONT-1 topline data were projected for Q2 2027 and 4FRONT-2 for H2 2027.