EyePoint (EYPT) investor relations material

Key clinical trial updates

• LUGANO phase III trial for vorolanib insert in wet AMD did not meet the primary endpoint, but showed strong secondary outcomes, including a 42% reduction in treatment burden and clean safety profile.

• Unusual control arm performance and vision loss in the treatment arm due to non-AMD causes explained the primary endpoint miss; secondary endpoints remained robust.

• Over half of patients maintained disease control for a year with the drug alone, and anatomic control was comparable to standard care.

• Repeat dosing safety was confirmed, supporting long-term use in chronic conditions.

• No significant differences in efficacy between treatment-naive and previously treated patients were observed.

Regulatory and future trial plans

• LUCIA, the second phase III trial, is identical in design to LUGANO but includes 20% international patients; data expected in Q4 2026.

• Sensitivity analyses in LUCIA will pre-specify exclusion of vision loss unrelated to wet AMD, addressing learnings from LUGANO.

• Positive LUCIA results would trigger an NDA filing in the first half of 2027, with optimism for regulatory acceptance if primary and secondary endpoints are met.

Commercial and competitive positioning

• Durability and reduction in injection frequency are key differentiators versus current agents; nearly 90% of patients could be managed with four or fewer injections per year.

• The product is positioned as a foundational therapy, potentially used alongside anti-VEGF biologics for synergistic effect.

• Flexibility in dosing and supplemental injections is expected to ease adoption in clinical practice.