EyePoint (EYPT) 12th Annual Cantor Fitzgerald Global Healthcare Conference summary

Key clinical findings and trial outcomes

• Secondary endpoints in the LUGANO trial showed strong safety and anatomic control, with a 40%+ reduction in treatment burden and over half of patients supplement-free at one year.

• The primary endpoint of non-inferiority in visual acuity was missed, attributed to an unprecedentedly low rate of vision loss in the control arm, not seen historically.

• Post-hoc analyses indicated that most vision loss in the treatment arm was unrelated to wet AMD, often due to other age-related eye conditions.

• Geographic atrophy rates and progression were similar or lower in the treatment arm compared to control, with no evidence the drug accelerated GA.

• Safety profile was favorable, with mild floaters as the main adverse event, and no significant issues with inflammation or other serious complications.

Adjustments and outlook for upcoming trials

• The LUCIA phase III trial will include more patients and pre-specified analyses to distinguish vision loss due to wet AMD from other causes.

• No changes to the primary endpoint or non-inferiority margin are planned, but supportive sensitivity analyses will be added.

• LUCIA data readout is expected in Q4, likely late October or early November.

• Positive LUCIA results, especially if supported by secondary endpoints, are expected to provide a strong case for regulatory approval.

• Additional presentations and analyses, including new findings on geographic atrophy and fibrosis, are scheduled at major ophthalmology conferences through December.

Implications for market and future studies

• Secondary endpoints, such as reduced injection frequency, are seen as highly meaningful by clinicians and could drive commercial success if approved.

• DME (diabetic macular edema) trials are fully enrolled, with safety and efficacy data from LUGANO seen as de-risking these studies.

• The company expects strong market penetration in DME due to the unmet need for fewer injections and faster vision improvement.

• Regulatory pathway is expected to rely on the totality of data, with no indication of a higher statistical hurdle for LUCIA.

• Further updates and data releases are planned at upcoming scientific meetings and on the company website.