EyePoint Pharmaceuticals (EYPT) 2024 Cantor Fitzgerald Global Healthcare Conference summary

Company overview and clinical focus

• Focused on improving outcomes for serious retinal diseases using sustained-release drug delivery technology.

• Preparing to launch two pivotal phase III trials in wet AMD, following strong phase II (DAVIO 2) results.

• Drug candidate Duravyu (vorolanib) targets maintenance therapy post-Eylea loading dose.

• Phase III trials will include both treatment-naive and previously treated patients for broader applicability.

• Process improvements allow higher drug payload with fewer inserts, optimizing cost of goods.

Phase II DAVIO 2 results and implications

• DAVIO 2 enrolled 160 previously treated wet AMD patients, comparing two doses of vorolanib to Eylea.

• Achieved non-inferiority in visual acuity at 12 months, matching Eylea without reinjection.

• Safety profile remains strong, with no reported ocular or systemic serious adverse events in 191 patients.

• Two-thirds of patients remained supplement-free up to month eight.

• Masked rescue criteria allowed direct comparison of supplement need between groups, showing no statistical difference.

Phase III trial design and regulatory alignment

• Primary endpoint is non-inferiority in visual acuity at one year, with six-month reinjection planned.

• Only one dose (2.7 mg) will be used, based on consistent anatomical benefits at higher dose.

• Both naive and previously treated patients will be enrolled, expected to improve outcomes and supplement-free rates.

• Rescue criteria require five-letter vision loss and 75 microns of new fluid; stricter than phase II.

• Over 130 sites committed, with staggered activation to optimize enrollment and data timelines.