Eyepoint, Inc. · NASDAQ:EYPT
Eyepoint — EyePoint Pharmaceuticals — Investor Day (June 2024)
57 slides from Eyepoint's investor day presentation, Jun 26, 2024
Slide 1: EyePoint Pharmaceuticals R&D Day 2024
UNIVERSITY CLUB | NEW YORK CITY | JUNE 26, 2024 ©2024 EyePoint Pharmaceuticals, Inc. All Rights Reserved. EyePoint Pharmaceuticals R&D Day 2024 Exhibit 99.1
Slide 2: Legal Disclaimers
Legal Disclaimers ©2024 EyePoint Pharmaceuticals, Inc. All Rights Reserved. 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
Slide 3: Introductions and Agenda
©2024 EyePoint Pharmaceuticals, Inc. All Rights Reserved. Introductions and Agenda Jay Duker, MD I President and Chief Executive Officer 3
Slide 4: R&D Day Speakers: Management
©2024 EyePoint Pharmaceuticals, Inc. All Rights Reserved. R&D Day Speakers: Management >30 years managing retinal diseases and is a 12-time clinical trial investigator/co investigator; he has started three companies and has published >345 ophthalmic journal articles. Previous Director of the New Eng
Slide 5: R&D Day Speakers: KOL Guest Speakers
©2024 EyePoint Pharmaceuticals, Inc. All Rights Reserved. Note: Dr. Modi and Dr. Regillo are paid consultants to EyePoint and are being compensated for their time in connection with this event. R&D Day Speakers: KOL Guest Speakers Associate Professor of Vitreoretinal Surgery, Retinal Disease and Uve
Slide 6: R&D Day: Agenda (1/2)
R&D Day: Agenda (1/2) ©2024 EyePoint Pharmaceuticals, Inc. All Rights Reserved. DURAVYU™ has been conditionally accepted by the FDA as the proprietary name for EYP-1901. DURAVYU is an investigational product; it has not been approved by the FDA. FDA approval and the timeline for potential approval i
Slide 7: R&D Day: Agenda (2/2)
R&D Day: Agenda (2/2) ©2024 EyePoint Pharmaceuticals, Inc. All Rights Reserved. PRESENTATION SPEAKER DURAVYU™: Pivotal Phase 3 Plans for Wet AMD Jay Duker, M.D. Ramiro Ribeiro, M.D., Ph.D. Early Pipeline Jay Duker, M.D. Key Opinion Leader Insights and Discussion Jay Duker, M.D. Carl D. Regillo, M.D.
Slide 8: R&D Day: Agenda
R&D Day: Agenda ©2024 EyePoint Pharmaceuticals, Inc. All Rights Reserved. PRESENTATION SPEAKER Introductions Jay Duker, M.D. Company Overview Jay Duker, M.D. DURAVYU™ (vorolanib intravitreal insert) Overview Jay Duker, M.D. DURAVYU™: Phase 2 DAVIO 2 Clinical Results and Sub-Group Analyses Yasha S. M
Slide 9: Committed to Developing Therapeutics to Improve the Lives of Patients with Serious Retinal Diseases
©2024 EyePoint Pharmaceuticals, Inc. All Rights Reserved. 9 Committed to Developing Therapeutics to Improve the Lives of Patients with Serious Retinal Diseases
Slide 10: Phase 3 Clinical Stage Company Leveraging Proven Delivery Technology
©2024 EyePoint Pharmaceuticals, Inc. All Rights Reserved. Phase 3 Clinical Stage Company Leveraging Proven Delivery Technology DURAVYU™ (vorolanib intravitreal insert) Multi-billion-dollar market opportunities Proprietary Durasert E™ drug delivery technology ~$280M of cash and investments1 No debt P
Slide 11: Pipeline Represents Potential Multi Billion-Dollar Product Opportunities
©2024 EyePoint Pharmaceuticals, Inc. All Rights Reserved. Pipeline Represents Potential Multi Billion-Dollar Product Opportunities wet AMD, wet age-related macular degeneration; EOP2, End of Phase 2; FPI, first patient in; NPDR, non-proliferative diabetic retinopathy; DME, diabetic macular edema; GA
Slide 12: Bioerodible Durasert E Technology
Bioerodible DURASERT E™ TECHNOLOGY Safe, Sustained-Release IVT Drug Delivery Delivered via a standard in-office IVT injection Continuous, daily therapeutic dose Zero-order kinetics drug release Durasert E™: bioerodible Drug embedded within a bioerodible matrix as a solid insert Designed to deplete d
Slide 13: R&D Day: Agenda
R&D Day: Agenda ©2024 EyePoint Pharmaceuticals, Inc. All Rights Reserved. PRESENTATION SPEAKER Introductions Jay Duker, M.D. Company Overview Jay Duker, M.D. DURAVYU™ (vorolanib intravitreal insert) Overview Jay Duker, M.D. DURAVYU™: Phase 2 DAVIO 2 Clinical Results and Sub-Group Analyses Yasha S. M
Slide 14: 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 ©2024 EyePoint Pharmaceuticals, Inc. All Rights Reserved. FDA, Food and Drug Administration; SAE, serious adverse event; MOA, mechanism of action No ocular or systemic DURAVYU-related SAEs across clinical trials SAFET
Slide 15: Vorolanib is a Potent and Highly Selective Pan-VEGF Receptor Inhibitor
©2024 EyePoint Pharmaceuticals, Inc. All Rights Reserved. Vorolanib is a Potent and Highly Selective Pan-VEGF Receptor Inhibitor Sophie Bakri, M.D., et al. PLOS ONE, https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0304782, 2024. VEGF(R), vascular endothelial growth factor (receptor
Slide 16: Vorolanib Demonstrated Clinical Activity in wet AMD Delivered Orally
Vorolanib Demonstrated Compelling Clinical Activity in wet AMD Delivered Orally ©2024 EyePoint Pharmaceuticals, Inc. All Rights Reserved. 16 Reduced supplemental therapy versus anti-VEGF PRN for all doses No ocular toxicity Systemic use significantly reduced fellow eye conversion Meaningful reductio
Slide 17: DURAVYU: Vorolanib in Bioerodible Durasert E
DURAVYU: Vorolanib in Bioerodible Durasert E™ ©2024 EyePoint Pharmaceuticals, Inc. All Rights Reserved. 17 Immediately bioavailable Controlled release for at least six months enables redosing regimen No free-floating drug - fully eluted prior to bioerosion of matrix Routine intravitreal injection Sh
Slide 18: DURAVYU Demonstrated Clinically Meaningful Safety and Efficacy Across Multiple Indications
DURAVYU Demonstrated Clinically Meaningful Safety and Efficacy Outcomes Across Multiple Indications ©2024 EyePoint Pharmaceuticals, Inc. All Rights Reserved. 18 Interim, masked safety as of June 2024 Wet AMD, wet age-related macular degeneration; NPDR, non-proliferative diabetic retinopathy; DME, di
Slide 19: R&D Day: Agenda
R&D Day: Agenda ©2024 EyePoint Pharmaceuticals, Inc. All Rights Reserved. PRESENTATION SPEAKER Introductions Jay Duker, M.D. Company Overview Jay Duker, M.D. DURAVYU™ (vorolanib intravitreal insert) Overview Jay Duker, M.D. DURAVYU™: Phase 2 DAVIO 2 Clinical Results and Sub-Group Analyses Yasha S. M
Slide 20: Significant Need for More Durable Therapies in Wet AMD
©2024 EyePoint Pharmaceuticals, Inc. All Rights Reserved. There is a Significant Need for More Durable Therapies in Wet AMD Many patients with wet AMD are chronically undertreated >80% of Retina Specialists say undertreatment is due to patient noncompliance, scheduling limitations or provider prefer
Slide 21: DAVIO 2 Clinical Trial Design
©2024 EyePoint Pharmaceuticals, Inc. All Rights Reserved. DAVIO 2 Clinical Trial is Randomized, Double-Masked, Aflibercept Controlled* with a Single DURAVYU Treatment at Two Doses *Aflibercept on-label control required by FDA -D14 to -D7 D1 W4 W8 W12 W16 W24 W32 W36 to W56 W20 W28 DURAVYU 2mg low do
Slide 22: DURAVYU Statistically Non-Inferior in Change in BCVA vs Aflibercept
©2024 EyePoint Pharmaceuticals, Inc. All Rights Reserved. DURAVYU was Statistically Non-Inferior in Change in BCVA Compared to the Aflibercept Control (95% CI) 1 – AAO 2022 presentation, Paolo Lanzetta, on behalf of the PULSAR study investigators DURAVYU 2mg -0.3* Mean Change in BCVA vs Aflibercept
Slide 23: Reduction in Treatment Burden Supports DURAVYU as a Maintenance Treatment
Clinically Meaningful Reduction in Treatment Burden Retrospectively Supports DURAVYU as a Maintenance Treatment For Wet AMD ©2024 EyePoint Pharmaceuticals, Inc. All Rights Reserved. DURAVYU 2mg DURAVYU 3mg Mean number of injections week 8 through week 32 0.55 0.73 Mean number of injections 6 months
Slide 24: Meaningful Reduction in Treatment Burden vs. Aflibercept Control Arm
DURAVYU Demonstrated a Meaningful Reduction in Treatment Burden Prospectively vs. the Aflibercept Control Arm ©2024 EyePoint Pharmaceuticals, Inc. All Rights Reserved. PRELIMINARY DATA – PENDING FINAL ANALYSIS DURAVYU 2mg DURAVYU 3mg Aflibercept 2mg q8W Mean number of injections week 8 through week
Slide 25: Nearly Two-Thirds of Eyes Supplement-Free up to Six Months
©2024 EyePoint Pharmaceuticals, Inc. All Rights Reserved. Nearly Two-Thirds of Eyes Treated with DURAVYU were Supplement-Free up to Six Months Summary of Supplement-Free Rates by Month 100% 100% *First visit patients are eligible to be supplemented EOM, every-other-month PRELIMINARY DATA – PENDING F
Slide 26: DURAVYU 2mg Dose Reduced Treatment Burden by 89%
©2024 EyePoint Pharmaceuticals, Inc. All Rights Reserved. PRELIMINARY DATA – PENDING FINAL ANALYSIS DURAVYU 2mg Dose Reduced Treatment Burden by 89% Compared to Prior 6 Months Injections in year prior and during the DAVIO 2 trial DURAVYU 3 mg (n = 52) DURAVYU 2 mg (n = 50) Anti-VEGF injection Aflibe
Slide 27: DURAVYU 3mg Dose Reduced Treatment Burden by 85%
©2024 EyePoint Pharmaceuticals, Inc. All Rights Reserved. PRELIMINARY DATA – PENDING FINAL ANALYSIS Injections in year prior and during DAVIO 2 trial DURAVYU 3 mg (n = 52) DURAVYU 2 mg (n = 50) Anti-VEGF injection Aflibercept loading dose Aflibercept + DURAVYU No injection Missed Visit Supplemental
Slide 28: Strong Anatomic Control at 6-Months Compared to Aflibercept
©2024 EyePoint Pharmaceuticals, Inc. All Rights Reserved. Data from DAVIO 2 Suggests Strong Anatomic Control at 6-Months Compared to the Aflibercept Control **Month 8 represents 6 months after first DURAVYU injection PRELIMINARY DATA – PENDING FINAL ANALYSIS DURAVYU 2mg +12.4 Mean Change in CST vs A
Slide 29: DAVIO 2 Case Study: Patient with Frequent Injections Maintained Six Months
©2024 EyePoint Pharmaceuticals, Inc. All Rights Reserved. DAVIO 2 Case Study: Patient with Frequent Anti-VEGF Injections Was Maintained for at Least Six Months After Receiving DURAVYU = administration of DURAVYU (3mg) = administration of aflibercept Screening Week 12 Week 24 Day 1 Week 16 Week 28 We
Slide 30: DAVIO 2 Case Study: Fluctuations in Fluid without Impact on Vision
©2024 EyePoint Pharmaceuticals, Inc. All Rights Reserved. DAVIO 2 Case Study: Patient Treated with DURAVYU had Fluctuations in Fluid without Impact on Vision BCVA, best-corrected visual acuity; CST, central subfield thickness. = administration of DURAVYU (3mg) = administration of aflibercept Screeni
Slide 31: DAVIO 2 Case Study: Patient Remained Dry with One Supplemental Injection
©2024 EyePoint Pharmaceuticals, Inc. All Rights Reserved. DAVIO 2 Case Study: Patient Treated with DURAVYU Remained Dry with Only One Supplemental Injection BCVA, best-corrected visual acuity; CST, central subfield thickness. Week 28 Week 32 = administration of DURAVYU (2mg) = administration of afli
Slide 32: DAVIO 2 Met All Primary and Secondary Endpoints
DURAVYU Phase 2 DAVIO 2 Clinical Trial in Wet AMD Met All Primary and Secondary Endpoints ©2024 EyePoint Pharmaceuticals, Inc. All Rights Reserved. . As of June 14, 2024 data cut PRELIMINARY DATA – PENDING FINAL ANALYSIS Endpoint 2mg 3mg R Primary: Non-inferior change in BCVA vs. aflibercept - 0.3 l
Slide 33: DAVIO 2 Trial in Wet AMD Sub-Group Analysis
©2024 EyePoint Pharmaceuticals, Inc. All Rights Reserved. Phase 2 DAVIO 2 Trial in Wet AMD Sub-Group Analysis
Slide 34: Sub-Group Analysis: Supplement-Free Patients Better Visual Acuity vs. Control
©2024 EyePoint Pharmaceuticals, Inc. All Rights Reserved. Sub-Group Analysis of Supplement-Free Patients Demonstrated Eyes Treated with DURAVYU had Numerically Better Visual Acuity vs. Control *Blended week 28 and week 32 change vs. baseline **Month 8 represents 6 months after DURAVYU injection PREL
Slide 35: Sub-Group Analysis: Strong Anatomic Control Up to 6-Months
©2024 EyePoint Pharmaceuticals, Inc. All Rights Reserved. Sub-Group Analysis of Supplement-Free Patients Demonstrated Strong Anatomic Control Up to 6-Months Compared to the Aflibercept Control *Month 8 represents 6 months after DURAVYU injection PRELIMINARY DATA – PENDING FINAL ANALYSIS DURAVYU 2mg
Slide 36: R&D Day: Agenda
R&D Day: Agenda ©2024 EyePoint Pharmaceuticals, Inc. All Rights Reserved. PRESENTATION SPEAKER Introductions Jay Duker, M.D. Company Overview Jay Duker, M.D. DURAVYU™ (vorolanib intravitreal insert) Overview Jay Duker, M.D. DURAVYU™: Phase 2 DAVIO 2 Clinical Results and Sub-Group Analyses Yasha S. M
Slide 37: Nearly Identical BCVA Compared to Aflibercept Through 12-Months
DURAVYU 2mg +0.4 Mean Change in BCVA vs Aflibercept DURAVYU 3mg +0.0 ©2024 EyePoint Pharmaceuticals, Inc. All Rights Reserved. -0.5 -0.1 -0.5 Nearly Identical BCVA Compared to Aflibercept Through 12-Months After a Single Injection; Statistically Significant (95% CI) MEAN CHANGE IN BCVA FROM BASELINE
Slide 38: Clinically Meaningful Supplement-Free Rates After Single Injection
©2024 EyePoint Pharmaceuticals, Inc. All Rights Reserved. Clinically Meaningful Supplement-Free Rates in DURAVYU Treated Eyes After Single Injection Summary of Supplement-Free Rates by Month 100% *First visit patients are eligible to be supplemented EOM, every-other-month PRELIMINARY DATA – PENDING
Slide 39: DAVIO 2 Strong Anatomic Control without Saw-Toothing
DURAVYU 2mg +10.0 Mean Change in CST vs Aflibercept DURAVYU 3mg -0.1 ©2024 EyePoint Pharmaceuticals, Inc. All Rights Reserved. +10.2 um +21.2 um +11.1 um PRELIMINARY DATA – PENDING FINAL ANALYSIS Data from DAVIO 2 Demonstrates Strong Anatomic Control in Eyes Treated with DURAVYU without Saw-Toothing
Slide 40: Favorable Safety Profile in DAVIO 2
DURAVYU Demonstrated a Favorable Safety Profile in the Phase 2 DAVIO 2 Clinical Trial No DURAVYU-related ocular or systemic SAEs No insert migration into the anterior chamber No retinal occlusive vasculitis Low patient discontinuation rate No discontinuations were related to DURAVYU treatment 1. As
Slide 41: Topline 12-Month DAVIO 2 Data Underscores Highly Positive Results
Topline 12-Month DAVIO 2 Data Underscores Highly Positive Results ©2024 EyePoint Pharmaceuticals, Inc. All Rights Reserved. 41 Efficacy: After a single injection, eyes treated with DURAVYU maintained stable visual acuity with strong anatomical control Approximately half of DURAVYU-treated eyes were
Slide 42: R&D Day: Agenda
R&D Day: Agenda ©2024 EyePoint Pharmaceuticals, Inc. All Rights Reserved. PRESENTATION SPEAKER DURAVYU™: Pivotal Phase 3 Plans for Wet AMD Jay Duker, M.D. Ramiro Ribeiro, M.D., Ph.D. Early Pipeline Jay Duker, M.D. Key Opinion Leader Insights and Discussion Jay Duker, M.D. Carl D. Regillo, M.D. Yasha
Slide 43: Clear Regulatory Pathway for Phase 3 Pivotal Trials in wet AMD
Clear Regulatory Pathway for Phase 3 Pivotal Trials in wet AMD Informed by Multiple FDA Interactions ©2024 EyePoint Pharmaceuticals, Inc. All Rights Reserved. 4Q 2022 Type C meeting to discuss pivotal trial design 4Q 2022 Received written FDA agreement on key trial design elements 3Q 2023 Initiated
Slide 44: Phase 3 Trials Designed to Enable Global Regulatory Approval
Phase 3 Trials are Designed to Enable Global Regulatory Approval of DURAVYU ©2024 EyePoint Pharmaceuticals, Inc. All Rights Reserved. Demonstrate DURAVYU, when administered every six months, achieves similar visual outcomes to on-label aflibercept while reducing treatment burden Two pivotal, non-inf
Slide 45: Phase 3 Program Designed to Drive Regulatory and Commercial Success
Phase 3 Program is Designed to Drive Global Regulatory and Commercial Success ©2024 EyePoint Pharmaceuticals, Inc. All Rights Reserved. Only sustained release wet AMD program to evaluate reinjection for label Trials will enroll patients with active wet AMD (previously treated and treatment naïve) Al
Slide 46: DURAVYU in Wet AMD Phase 3 Pivotal Trial Design
DURAVYU in Wet AMD Phase 3 Pivotal Trial Design ©2024 EyePoint Pharmaceuticals, Inc. All Rights Reserved. Screening D1 W4 W8 W12 W16 W24 W32 W84-W92 W20 W28 DURAVYU 2.7mg Aflibercept 2mg q8W RANDOMIZATION REQUIRED AFLIBERCEPT INJECTION VISIT VISIT SCHEDULED DURAVYU DOSE AFLIBERCEPT q8W 1⁰ ENDPOINT B
Slide 47: Broad Patient Population in Phase 3 Pivotal Trials
A Broad Patient Population in the Phase 3 Pivotal Trials has the Potential to Enhance Trial Outcomes and Increase Commercial Opportunity ©2024 EyePoint Pharmaceuticals, Inc. All Rights Reserved. Enriches trial to have more supplement-free eyes, which had better outcomes in DAVIO 2 Ensures broad labe
Slide 48: Broad Patient Population Enhances Trial Outcomes and Commercial Opportunity
A Broad Patient Population in the Phase 3 Pivotal Trials has the Potential to Enhance Trial Outcomes and Increase Commercial Opportunity ©2024 EyePoint Pharmaceuticals, Inc. All Rights Reserved. 1. Patients diagnosed ≤1 year with ≤2 prior αVEGF injections Highly positive, statistically non-inferior
Slide 49: Commercial Manufacturing Facility
Commercial Manufacturing Facility ©2024 EyePoint Pharmaceuticals, Inc. All Rights Reserved. FDA, Federal Drug Administration; EMA, European Medicines Agency Conveniently located in Northbridge, MA, near EyePoint headquarters Built to US FDA and EU EMA standards 40,000 sqft cGMP manufacturing facilit
Slide 50: R&D Day: Agenda
R&D Day: Agenda ©2024 EyePoint Pharmaceuticals, Inc. All Rights Reserved. PRESENTATION SPEAKER DURAVYU™: Pivotal Phase 3 Plans for Wet AMD Jay Duker, M.D. Ramiro Ribeiro, M.D., Ph.D. Early Pipeline Jay Duker, M.D. Key Opinion Leader Insights and Discussion Jay Duker, M.D. Carl D. Regillo, M.D. Yasha
Slide 51: EYP-2301: Razuprotafib in Durasert E, a Patented TIE-2 Agonist
EYP-2301: Razuprotafib in Durasert E™ is a Patented TIE-2 Agonist as a Potential New MOA for Treating Serious Retinal Diseases ©2024 EyePoint Pharmaceuticals, Inc. All Rights Reserved. 1. Heier et al. Retina, 2021;41:1-19. and Joussen et al. Eye 2021; 35:1305-1316.; 2. Hammes, et. Al – Diabetes.2011
Slide 52: R&D Day: Agenda
R&D Day: Agenda ©2024 EyePoint Pharmaceuticals, Inc. All Rights Reserved. PRESENTATION SPEAKER DURAVYU™: Pivotal Phase 3 Plans for Wet AMD Jay Duker, M.D. Ramiro Ribeiro, M.D., Ph.D. Early Pipeline Jay Duker, M.D. Key Opinion Leader Insights and Discussion Jay Duker, M.D. Carl D. Regillo, M.D. Yasha
Slide 53: R&D Day: Agenda
R&D Day: Agenda ©2024 EyePoint Pharmaceuticals, Inc. All Rights Reserved. PRESENTATION SPEAKER DURAVYU™: Pivotal Phase 3 Plans for Wet AMD Jay Duker, M.D. Ramiro Ribeiro, M.D., Ph.D. Early Pipeline Jay Duker, M.D. Key Opinion Leader Insights and Discussion Jay Duker, M.D. Carl D. Regillo, M.D. Yasha
Slide 54: R&D Day: Agenda
R&D Day: Agenda ©2024 EyePoint Pharmaceuticals, Inc. All Rights Reserved. PRESENTATION SPEAKER DURAVYU™: Pivotal Phase 3 Plans for Wet AMD Jay Duker, M.D. Ramiro Ribeiro, M.D., Ph.D. Early Pipeline Jay Duker, M.D. Key Opinion Leader Insights and Discussion Jay Duker, M.D. Carl D. Regillo, M.D. Yasha
Slide 55: Data from Studies to be Presented at Upcoming Meetings
Data from Clinical and Preclinical Studies will be Presented at Multiple Upcoming Meetings ©2024 EyePoint Pharmaceuticals, Inc. All Rights Reserved. Medical Conference Data Timing ASRS New DAVIO 2 sub-group analyses July 2024 American Retina Forum Encore presentation of XX data August 2024 Retina So
Slide 56: 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 ©2024 EyePoint Pharmaceuticals, Inc. All Rights Reserved. FDA, Food and Drug Administration; SAE, serious adverse event; MOA, mechanism of action No ocular or systemic DURAVYU-related SAEs across clinical trials SAFET
Slide 57: EyePoint Pharmaceuticals R&D Day 2024
UNIVERSITY CLUB | NEW YORK CITY | JUNE 26, 2024 ©2024 EyePoint Pharmaceuticals, Inc. All Rights Reserved. EyePoint Pharmaceuticals R&D Day 2024