EyePoint (EYPT) investor relations material

Clinical trial updates and data interpretation

• LUGANO phase III trial did not meet its primary endpoint in the full analysis set, but showed strong secondary endpoints, including safety and significant reduction in treatment burden for wet AMD patients.

• Anomalously low vision loss in the control arm and asymmetric distribution of non-AMD-related vision loss in the DURAVYU arm were identified as key reasons for missing the primary endpoint.

• Over half of patients in the DURAVYU arm maintained disease control for a full year with the drug alone, and the safety profile remained clean even with repeat dosing.

• Physicians are enthusiastic about the reduction in treatment burden, which exceeded expectations compared to other agents.

• No evidence was found that the drug accelerates geographic atrophy; vision loss was linked to baseline characteristics rather than drug effect.

Forward-looking plans and regulatory strategy

• The upcoming LUCIA phase III trial is nearly identical to LUGANO, with a broader geographic mix and a pre-specified sensitivity analysis to address vision loss unrelated to wet AMD.

• Positive LUCIA results would prompt an NDA filing in the first half of next year, with commercial success hinging on both primary and strong secondary endpoints.

• The team is optimistic about FDA review, citing precedent for approval with mixed phase III results and strong clinical rationale.

• Commercial opportunity is seen as strong if the drug can further reduce injection frequency and offer flexibility in combination with existing therapies.

Commercial and operational preparations

• Manufacturing scale-up and automation have been prioritized to ensure commercial readiness, with a state-of-the-art facility and automated inspection processes in place.

• Commercial leadership and payer engagement have begun, with major spending planned post-NDA approval.

• Cash runway extends into Q4 2027, with additional funding options available depending on trial outcomes and regulatory milestones.