Slide 1: 8-month Results of Vorolanib in Bio-erodible Durasert Implant: The DAVIO Trial
Jay S. Duker, M.D. Chief Operating Officer EyePoint Pharma 8-month Results of a Tyrosine Kinase Inhibitor (Vorolanib) in a Bio-erodible Durasert® Implant for Previously Treated Wet AMD: The DAVIO Trial Exhibit 99.1
Slide 2: Financial Interest Disclosure – Jay S. Duker, M.D.
Employee - EyePoint Pharma Board of Directors - Sesen Bio - Hubble Tx Consultant - Aura Bio Financial Interest Disclosure – Jay S. Duker, M.D.
Slide 3: Forward-looking statements
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, events or developments
Slide 4: DAVIO Take Home Messages: EYP-1901 Phase 1 Clinical Trial Met All Objectives
All objectives successfully met: Proof of Concept for Vorolanib in wet AMD Positive Safety Data No ocular SAEs reported No drug-related systemic SAEs reported Ocular AEs - majority mild and to be expected EFFICACY and DURABILITY Positive Efficacy Data Stable VA and OCT Median time to supplemental an
Slide 5: EYP-1901 – Vorolanib in Bio-erodible Durasert: A Novel Approach to Wet AMD Therapy
EYP-1901 – Vorolanib in Bio-erodible Durasert A Novel Approach to Wet AMD Therapy 5 Vorolanib as an Oral Therapy Receptor-binding, small molecule tyrosine kinase inhibitor (TKI) Activity against all isoforms of VEGF and PDGF Oral vorolanib previously studied in a wet AMD ph1 and ph2 programs1,2 Stro
Slide 6: Bioerodible Durasert Platform: injectable, sustained-delivery technology
Bioerodible Durasert® Platform: injectable, sustained-delivery technology Similar to YUTIQ®, Retisert®, and Vitrasert® Main difference: No polyimide shell ---> Bioerodible Drug release dynamics Initial burst from surface of implant Constant, zero-order kinetic release rate for months Designed for ap
Slide 7: DAVIO Phase 1 Trial Design: Open Label, Dose Escalation, No Control Arm
NO EYP-1901 retreatments Criteria for supplemental anti-VEGF therapy*: New fluid > 75 microns (OCT) compared to Day-0 2 lines of BCVA secondary to wet AMD compared to Day-0 New macular hemorrhage secondary to wet AMD Enrollment Previously treated wet AMD eyes only No exclusion for presence of fluid
Slide 8: EYP-1901 Phase 1 DAVIO Participants
BCVA: best corrected visual acuity; ETDRS: Early Treatment Diabetic Retinopathy Study; CST: central subfield thickness EYP-1901 Phase 1 DAVIO Participants
Slide 9: DAVIO Primary Endpoint – Safety: Positive Overall Safety Data
Ocular AEs of particular interest: No vitreous floaters No endophthalmitis No retinal detachment No implant migration in the anterior chamber No retinal vasculitis No posterior segment inflammation AC, anterior chamber; AE, adverse event; BCVA, best corrected visual acuity; SAE, serious adverse even
Slide 10: Clinically Significant Reduction in Treatment Burden - 79% at Six Months
SOC Anti-VEGF Injections Before and After Treatment SoC (Anti-VEGF) + EYP1901 ● Anti-VEGF ○ No supplemental injection given ☐ Missed visit months Clinically Significant Reduction in Treatment Burden - 79 % at Six Months EYP-1901 Phase 1 DAVIO Study – Interim data – monitored through 6 months
Slide 11: Clinically Significant Reduction in Treatment Burden - 75% at 8 Months
SOC Anti-VEGF Injections Before and After Treatment SoC (Anti-VEGF) + EYP1901 ● Anti-VEGF ○ No supplemental injection given ☐ Missed visit months Clinically Significant Reduction in Treatment Burden - 75 % at 8 Months EYP-1901 Phase 1 DAVIO Study Interim data – monitored through 6 months
Slide 12: Average Visual Acuity and Central Subfield Thickness Stable - 8 Months
Results: Average Visual Acuity (VA) and Central Subfield Thickness (CST) Stable - 8 Months After Single Treatment BCVA: best corrected visual acuity Interim data – monitored through 6 months For all 17 eyes at 8 months VA = -3.0 letters OCT: optical coherence tomography; CST: central subfield thickn
Slide 13: Rescue-free Rates Up to Each Visit: Entire Study Group
Interim data – monitored through 6 months Rescue-free Rates Up to Each Visit: Entire Study Group Median Time to supplemental anti-VEGF = 6 Months
Slide 14: Patient 1: Entered Dry, Stayed Dry for 12 Months with No Supplemental anti-VEGF
Screening Visit: 6 anti-VEGF injections prior to enrollment Initial Diagnosis: 9 months prior to enrollment Initial Diagnosis 9 mo before enrollment Screening visit prior to treatment Patient 1: Entered Dry, Stayed Dry for 12 Months with No Supplemental anti-VEGF Low dose cohort (EYP-1901 440 µg)
Slide 15: Patient 1: Post-Treatment - No Supplemental Anti-VEGF Through Month 12
Month 5 – no tx Patient 1: Post-Treatment - No Supplemental Anti-VEGF Through Month 12 Low dose cohort (EYP-1901 440 µg)
Slide 16: Rescue-Free Eyes: VA and CST Both Stable
At 8 months follow up, 7 of 17 (41 %) Eyes Rescue-Free VA and CST both stable for these 7 eyes For all 7 eyes at 8 months VA = +0.4 letters BCVA: best corrected visual acuity Interim data – monitored through 6 months For all 7 eyes at 8 months CST on OCT = +13.6 microns
Slide 17: Longevity of Efficacy – Six of Seven Unsupplemented Eyes Remain Dry
Med Dose Case #3 Month 8 Longevity of Efficacy – At 8 months post EYP-1901, Six of Seven Unsupplemented Eyes Remain Dry Med Dose Case #4 Month 8 Low-Mid Dose Month 8 Low Dose Month 8 Med Dose Case #1 Month 8 High Dose Month 8 Med Dose Case #2 Month 9* *Month 8 = missed visit
Slide 18: Medium Dose Cases: Month 8 Imaging
Month 5 – no tx Med Dose Case #1 Month 10 Med Dose Case #4 Month 8 Low-Mid Dose Month 9 18 | EYEPOINT PHARMACEUTICALS
Slide 19: Next Steps for EYP-1901: Three Phase 2 Trials Planned
Next Steps for EYP-1901 Advance EYP-1901 into three Phase 2 clinical trials by 2023 Wet AMD initiation expected in 3Q 2022 Diabetic Retinopathy initiation expected in 2H 2022 Third Indication - initiation expected by Q1 2023 Wet AMD Trial Design N = 144 3 arms: EYP-1901 2 mg; EYP-190 3 mg; Eylea con
Slide 20: Retrospective DAVIO Sub-Group Analysis (N=10)
Retrospective DAVIO Sub-Group Analysis (N=10) Based on Potential Entry Criteria and Anticipated Dosing in Phase 2 Wet AMD Study – 89 % reduction in Treatment Burden at 8 months – 50 % unsupplemented up to month 9 SoC (Anti-VEGF) + EYP1901 ● Anti-VEGF ○ No supplemental injection given ☐ Missed visit
Slide 21: DAVIO Take Home Messages: EYP-1901 Phase 1 Clinical Trial Met All Objectives
All objectives successfully met: Proof of Concept for Vorolanib in wet AMD Positive Safety Data No ocular SAEs reported No drug-related systemic SAEs reported Ocular AEs - majority mild and to be expected EFFICACY and DURABILITY Positive Efficacy Data Stable VA and OCT Median time to supplemental an