EyePoint (EYPT) Corporate presentation summary

Program overview and clinical development

• DURAVYU targets wet AMD and DME, the two largest retinal disease markets, with a total addressable market of ~$15B.

• Four Phase 3 trials were enrolled in under seven months, with a commercial cGMP facility ready for US launch.

• LUGANO and LUCIA pivotal Phase 3 trials follow an established non-inferiority regulatory path, comparing DURAVYU to on-label aflibercept.

• LUGANO enrolled 432 patients, with DURAVYU dosed every six months and aflibercept every eight weeks.

• NDA submission for wet AMD is targeted for the first half of 2027, pending positive LUCIA results.

Efficacy and treatment burden

• DURAVYU did not achieve statistical non-inferiority in the full LUGANO dataset but was non-inferior when excluding an asymmetric cohort with vision loss unrelated to wet AMD.

• Superior reduction in treatment burden was observed, with a 42% reduction in injections compared to aflibercept (nominal p < 0.0001).

• Over 50% of eyes were controlled by DURAVYU alone up to Week 56, with 79% receiving zero or one supplement.

• Supplement-free subgroup analysis confirmed non-inferiority in visual acuity outcomes.

• Modeling and ad hoc analyses support the robustness of the efficacy findings, accounting for outlier effects.

Safety and anatomical outcomes

• DURAVYU demonstrated a favorable safety profile with repeat dosing, with no cases of severe intraocular inflammation or retinal vasculitis.

• Adverse events of particular interest were all below 1% in both arms, and discontinuation rates were low and unrelated to DURAVYU.

• Anatomic control was maintained, with similar or lower rates of geographic atrophy onset and progression compared to aflibercept.

• DURAVYU arm showed a lower rate of fibrosis progression versus aflibercept.

• Case studies illustrated both significant vision gains and the impact of geographic atrophy on outcomes.