Eyepoint, Inc. · NASDAQ:EYPT
Eyepoint — FLORetina/ICOOR Meeting 2024
14 slides from Eyepoint's conference presentation, Dec 6, 2024
Slide 1: EYP-1901 for the Treatment of Wet AMD: Phase 2 DAVIO 2 End-of-Study Results
EYP-1901 for the Treatment of Wet AMD: Phase 2 DAVIO 2 End-of-Study Results Carl D. Regillo, MD, FACS, FASRS1 on behalf of DAVIO 2 investigators 1. Mid Atlantic Retina, Wills Eye Hospital, Philadelphia, PA, USA FLORetina/ICOOR Meeting 2024 These data are preliminary. Conclusive evidence of efficacy
Slide 2: Disclosures
Presenter Disclosures Consultant: 4DMT, Adverum, Allergan, Annexon, Apellis, Aviceda, Bausch and Lomb, Clearside, Cognition, EyePoint, Genentech, Iveric, Janssen, Kodiak, Lineage, Merck, NGM, Novartis, Ocugen, Ocuterra, Occuphire, Opthea, Ray, RegenXBio, Stealth, Thea, Zeiss; Research grant support
Slide 3: EYP-1901: Vorolanib Intravitreal Insert
EYP-1901: Vorolanib Intravitreal Insert EYP-1901 Vorolanib Intravitreal Insert 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
Slide 4: DAVIO 2: Phase 2 Trial of EYP-1901 vs Aflibercept in Previously-treated Wet AMD
END OF DAVIO 2 | STUDY DAVIO 2: Phase 2 Trial of EYP-1901 vs Aflibercept in Patients With Previously-treated Wet AMD Primary endpoint End of study EYP-1901 dosing Blend W28 & W32 Key Inclusion & 161 patients D1 W4 W8 W12 W16 W20 W24 W28 W32 W36 W40 W44 W48 W52 W56 Exclusion Criteria EYP-1901 2 mg lo
Slide 5: Baseline Characteristics: Well-balanced Across Treatment Arms
END OF DAVIO 2 | STUDY Baseline Characteristics: Well-balanced Across Treatment Arms EYP-1901 2 mg EYP-1901 3 mg Aflibercept 2 mg q8W (n = 50) (n = 52) (n = 54) Baseline Characteristics (N = 156) Age, mean years (range) 76 (61–93) 75 (56–89) 76 (52–93) Female, % 64% 67% 54% Study eye BCVA, mean ETDR
Slide 6: BCVA Outcomes: Nearly Identical With EYP-1901 and Aflibercept Throughout the Study
END OF DAVIO 2 | STUDY BCVA Outcomes: Nearly Identical With EYP-1901 and Aflibercept Throughout the Study EYP-1901 dosing 15 Expected minimum duration of EYP-1901 in humans Primary 10 endpoint met BCVA change from baseline, mean ± SD ETDRS letters 5 0 Month 7/8 -5 Average EYP-1901 2 mg 1.0 -10 EYP-1
Slide 7: BCVA Outcomes: Nearly Identical With EYP-1901 and Aflibercept Throughout the Study
END OF DAVIO 2 | STUDY BCVA Outcomes: Nearly Identical With EYP-1901 and Aflibercept Throughout the Study EYP-1901 dosing 15 Extended durability and efficacy Expected minimum duration of EYP-1901 in humans follow-up Below therapeutic threshold Primary 10 endpoint met BCVA change from baseline, mean
Slide 8: OCT Outcomes: EYP-1901 Demonstrated Strong Anatomic Control-Month 14
END OF DAVIO 2 | STUDY OCT Outcomes: EYP-1901 Demonstrated Strong Anatomic Control-Month 14 EYP-1901 dosing 100 Extended durability and efficacy Expected minimum duration of EYP-1901 in humans follow-up Below therapeutic threshold 80 60 40 CST change from baseline, mean ± SD μm 20 0 -20 Month 8 Mont
Slide 9: Proportion of Eyes Not Meeting Supplemental Criteria-Aflibercept Arm
END OF DAVIO 2 | STUDY Proportion of Eyes Not Meeting Supplemental Criteria-Aflibercept Arm 100% 87% Eyes supplemental injection–free 80% 68% 65% up to specified week, %a 60% 40% 20% 0% Month 2 Month 3 Month 4 Month 5 Month 6 Month 7 Month 8 Month 9 Month 10 Month 11 Month 12 Month 13 Month 14 Aflib
Slide 10: Proportion of Eyes Not Meeting Supplemental Criteria-All arms Month 14
END OF DAVIO 2 | STUDY Proportion of Eyes Not Meeting Supplemental Criteria-All arms Month 14 EYP-1901 dosing Extended durability and safety Expected minimum duration of EYP-1901 in humans follow-up Below therapeutic threshold 100% 87% Eyes supplemental injection–free 80% 68% 65% up to specified wee
Slide 11: Treatment Burden vs Prior 12 Months
END OF DAVIO 2 | STUDY Treatment Burden vs Prior 12 Months Pre-trial treatment, months Study visit, months 12 11 10 9 8 7 6 5 4 3 2 1 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 43% injection free up to Month 14 81% reduction EYP-1901 Pre-trial anti-VEGF 2 mg vs pre-trial Scheduled aflibercept n = 49 treatme
Slide 12: Safety: EYP-1901 Demonstrated a Favorable Safety Profile Through End of Study
END OF DAVIO 2 | STUDY Safety: EYP-1901 Demonstrated a Favorable Safety Profile Through End of Study Key Safety Findings • No EYP-1901–related ocular SAEs or systemic SAEs • No insert migration into the anterior chamber • No cases of retinal occlusive vasculitis • No discontinuations related to EYP-
Slide 13: Summary
Summary DAVIO 2 is the largest IVT TKI trial to date With one injection of EYP-1901: • EYP-1901 maintained stable visual acuity with strong anatomical control • EYP-1901-treated eyes were supplement-free: • 63% at 6 months after EYP-1901 dosing • 44% at 12 months after EYP-1901 dosing EYP-1901 demon
Slide 14: EYP-1901 in Wet AMD: Phase 3 Pivotal Trial Design
EYP-1901 in Wet AMD: Phase 3 Pivotal Trial Design LUGANO & LUCIA: Patients with wet AMD, previously-treated or treatment-naïve Primary endpoint Blend W52 & W56 EYP-1901 dosing EYP-1901 dosing EYP-1901 dosing W60 to W84 to W96 D1 W4 W8 W12 W16 W20 W24 W28 W32 W36 W40 W44 W48 W52 W56 W80 W76 W92 EOS E