Slide 1: Committed to Developing Therapeutics to Help Improve the Lives of Patients with Serious Retinal Disease
Committed to Developing Therapeutics to Help Improve the Lives of Patients with Serious Retinal Disease Jay S. Duker, M.D. President & CEO Eyecelerator @ AAO 2024 DURAVYU has been conditionally accepted by the FDA as the proprietary name for DURAVYU. DURAVYU is an investigational product; ©2024 EyeP
Slide 2: Legal Disclaimers
Legal Disclaimers Various statements made in this presentation are forward-looking, within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, and are inherently subject to risks, uncertainties and potentially inaccurate assumptions. All statements that address activities, even
Slide 3: Phase 3 Clinical Stage Biotech Company Pursuing Multi-Billion Dollar Markets
Phase 3 Clinical Stage Biotech Company Pursuing Multi-Billion Dollar Markets Phase 3 DURAVYU (vorolanib intravitreal insert) Asset Focused Multi-billion-dollar market opportunities Pipeline Proven Technology Proprietary Durasert E IVT drug delivery Strong $280M of cash and investments on June 30, 20
Slide 4: DURAVYU (EYP-1901): Vorolanib in Durasert E
DURAVYU (EYP-1901): Vorolanib in Durasert E DURAVYU Vorolanib Durasert E Controlled release over a Potent receptor tyrosine kinase Bioerodible, sustained period of at least 6 months inhibitor (TKI): selectively inhibits all IVT drug delivery VEGF signaling No delay – reaches target tissues at therap
Slide 5: DAVIO 2 Clinical Trial in Wet AMD Met All Primary and Secondary Endpoints
DURAVYU Phase 2 DAVIO 2 Clinical Trial in Wet AMD Met All Primary and Secondary Endpoints Endpoint 2mg 3mg Primary: Non-inferior change in BCVA vs. - 0.3 letters1 - 0.4 letters1 aflibercept Secondary: Favorable safety profile1 No DURAVYU -related SAEs Secondary: Reduction in treatment 89% 85%
Slide 6: Phase 3 Pivotal Trials Design
Phase 3 Pivotal Trials Design NON-INFERIORITY VERSUS AN AFLIBERCEPT CONTROL ©2024 EyePoint Pharmaceuticals, Inc. All Rights Reserved.
Slide 7: Trials are Designed to Enable Global Regulatory Approval of DURAVYU Based on Positive FDA Meetings
Phase 3 Trials are Designed to Enable Global Regulatory Approval of DURAVYU Based on Positive FDA Meetings LUGANO AND LUCIA TRIALS: GLOBAL, RANDOMIZED, DOUBLE-MASKED, AFLIBERCEPT CONTROLLED OBJECTIVE TRIAL DESIGN • ~400 patients per trial Demonstrate DURAVYU , when • Two arms administered every six
Slide 8: DURAVYU in Wet AMD Phase 3 Pivotal Trial Design
DURAVYU in Wet AMD Phase 3 Pivotal Trial Design W60- W84- W96 Screening D1 W4 W8 W12 W16 W20 W24 W28 W32 W36 W40 W44 W48 W52 W56 W80 W76 W92 EOS RA NDOMI Z AT IO N DURA VY U DURA VY U DURA VY U DURA VY U DURAVYU 2.7mg Aflibercept 2mg q8W A FL IB ERCE PT A FL IB ERCE PT q 8W LO A D 1⁰ ENDP OI NT BL E
Slide 9: DURAVYU: vorolanib in Durasert E Phase 2 VERONA Clinical Trial in DME
DURAVYU : vorolanib in Durasert E PHASE 2 VERONA CLINICAL TRIAL IN DIABETIC MACULAR EDEMA (DME) ©2024 EyePoint Pharmaceuticals, Inc. All Rights Reserved.
Slide 10: Phase 2 VERONA Clinical Trial is Randomized, Open-Label, Aflibercept Controlled in DME
Phase 2 VERONA Clinical Trial is Randomized, Open-Label, Aflibercept Controlled with a Single DURAVYU Treatment in DME PR I MA R Y EN D PO I N T -D28 to D1 W4 W8 W12 W16 W20 W24 -D7 DURAVYU low dose (n=10) DURAVYU high dose (n=10) Aflibercept 2mg single injection (n=5) SUPPLEMENTAL ANTI-VEGF INJECTI
Slide 11: DURAVYU entering Phase 3 with robust dataset and FDA alignment on approval pathway
DURAVYU entering Phase 3 with robust dataset and FDA alignment on approval pathway No ocular or systemic DURAVYU-related SAEs across multiple SAFETY indications FDA Non-inferiority pathway to approval aligned with FDA DATA Most robust dataset of all long-acting treatments in development TRIAL Phase