Eyepoint, Inc. · NASDAQ:EYPT
Eyepoint — EyePoint Pharmaceuticals — J.P. Morgan Healthcare Conference 2024
43 slides from Eyepoint's conference presentation, Jan 10, 2024
Slide 1: J.P. Morgan Healthcare Conference Presentation
J.P. Morgan Healthcare Conference Presentation January 10, 2024 Jay Duker, M.D. President and CEO ©2023 EyePoint Pharmaceuticals, Inc. All Rights Reserved. Exhibit 99.1
Slide 2: Legal Disclaimers
Legal Disclaimers ©2023 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: Pipeline represents multi billion-dollar opportunities using Durasert E delivery technology
©2023 EyePoint Pharmaceuticals, Inc. All Rights Reserved. IVT, intravitreal injection Pipeline represents multi billion-dollar opportunities using our bioerodible Durasert E™ IVT delivery technology EYP-1901 – vorolanib, a selective and patented TKI in Durasert E™ Positive topline Phase 2 data in we
Slide 4: Durasert E Programs
©2023 EyePoint Pharmaceuticals, Inc. All Rights Reserved. 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, geographic atrophy Durasert E™ Programs Indication Discovery Pre-Clin P
Slide 5: Safe, Sustained IVT Drug Delivery
©2023 EyePoint Pharmaceuticals, Inc. All Rights Reserved. Safe, Sustained IVT Drug Delivery Delivered via a standard in-office IVT injection Continuous, stable release of drug Zero-order kinetics Durasert®: non-erodible Drug embedded within a bioerodible matrix covered with non-erodible polyimide sh
Slide 6: Vorolanib Brings a Potential New MOA to Treatment of VEGF-Mediated Retinal Diseases
©2023 EyePoint Pharmaceuticals, Inc. All Rights Reserved. SoC, standard of care; ANG, angiopoietin; PDGF(R), platelet-derived growth factor (receptor); PLGF, placental growth factor; TIE-2, tyrosine-protein kinase receptor TIE-2; VEGF(R), vascular endothelial growth factor (receptor). Potent and sel
Slide 7: EYP-1901: Vorolanib in Bioerodible Durasert E
©2023 EyePoint Pharmaceuticals, Inc. All Rights Reserved. Each insert ~1/5000 of vitreous volume Delivered in the physician office via standard intravitreal injection technique Immediately bioavailable featuring an initial burst of drug followed by zero order kinetics release for ~9 months Positive
Slide 8: Phase 2 DAVIO 2 Clinical Trial Topline Results
©2023 EyePoint Pharmaceuticals, Inc. All Rights Reserved. Phase 2 DAVIO 2 Clinical Trial Topline Results A NON-INFERIORITY TRIAL VERSUS AN AFLIBERCEPT CONTROL
Slide 9: The DAVIO 2 Clinical Trial
©2023 EyePoint Pharmaceuticals, Inc. All Rights Reserved. The DAVIO 2 Clinical Trial A non-inferiority trial evaluating two doses of EYP-1901 against an aflibercept control in wet AMD The DAVIO 2 clinical trial was designed to evaluate EYP-1901 in wet AMD and support Phase 3 clinical trials based on
Slide 10: DAVIO 2 Trial Design
DAVIO 2 Clinical Trial is Randomized, Double-Masked, Aflibercept Controlled* with a Single EYP-1901 Treatment at Two Doses ©2023 EyePoint Pharmaceuticals, Inc. All Rights Reserved. -D14 to -D7 D1 W4 W8 W12 W16 W24 W32 W36 to W56 W20 W28 EYP-1901 2mg low dose n=53 EYP-1901 3mg high dose n=54 Afliberc
Slide 11: DAVIO 2 Patient Baseline Characteristics
DAVIO 2 Patient Baseline Characteristics Well Balanced Across Arms ©2023 EyePoint Pharmaceuticals, Inc. All Rights Reserved. Aflibercept 2mg q8W (n=54) EYP-1901 2mg (n=50) EYP-1901 3mg (n=52) Mean age, years (range) 75.9 (52-93) 76.4 (61-93) 75.4 (56-89) Female, % 53.7% 64.0% 67.3% Mean BCVA, ETDRS
Slide 12: EYP-1901 Phase 2 DAVIO 2 Met All Objectives
EYP-1901 Phase 2 DAVIO 2 Clinical Trial Met All Objectives ©2023 EyePoint Pharmaceuticals, Inc. All Rights Reserved. 1. As of November 7, 2023 data cut PRELIMINARY DATA – PENDING FINAL ANALYSIS Endpoint Achieved Endpoint? 2mg 3mg Primary: Non-inferior change in BCVA vs. aflibercept - 0.3 letters - 0
Slide 13: DAVIO 2 Achieved Primary Endpoint of Non-Inferiority in Visual Acuity
DAVIO 2 Achieved Primary Endpoint of Non-Inferiority Change in Visual Acuity in Both EYP-1901 Arms; Statistically and Numerically Non-Inferior to Control (95% CI) ©2023 EyePoint Pharmaceuticals, Inc. All Rights Reserved. EYP-1901 2mg EYP-1901 3mg Aflibercept 2mg q8W Change in BCVA* vs. Baseline + 1.
Slide 14: EYP-1901 Non-Inferior in Change in BCVA vs Aflibercept
©2023 EyePoint Pharmaceuticals, Inc. All Rights Reserved. +0.9* +1.0* +1.3* EYP-1901 was Statistically Non-Inferior in Change in BCVA Compared to the Aflibercept Control (95% CI) MEAN CHANGE IN BCVA FROM BASELINE EYP-1901 2mg - 0.3* EYP 1901 3mg - 0.4* Diff vs. Aflibercept Control *Blended week 28 a
Slide 15: EYP-1901 Favorable Safety Profile in DAVIO 2
EYP-1901 Demonstrated a Favorable Safety Profile in the Phase 2 DAVIO 2 Clinical Trial1 ©2023 EyePoint Pharmaceuticals, Inc. All Rights Reserved. SAE, serious adverse event; AE, adverse event; IVT, intravitreal injection PRELIMINARY DATA CUT– PENDING FINAL ANALYSIS 1- As of November 7, 2023 data cut
Slide 16: Reported SAEs Deemed Unrelated to EYP-1901
In the Phase 2 DAVIO 2 Trial the Reported SAEs Occurred After an Aflibercept Injection or Paracentesis and Were Deemed Unrelated to EYP-19011 ©2023 EyePoint Pharmaceuticals, Inc. All Rights Reserved. SAE, serious adverse event; CPAP, continuous positive airway pressure PRELIMINARY DATA CUT– PENDING
Slide 17: EYP-1901 Well Tolerated, AEs Generally Mild
EYP-1901 was Well Tolerated - AE’s Generally Mild and Self-Limiting Through Six Months ©2023 EyePoint Pharmaceuticals, Inc. All Rights Reserved. SAE, serious adverse event; AE, adverse event PRELIMINARY DATA CUT– PENDING FINAL ANALYSIS Data as of November 7, 2023 data cut 1- as deemed by the investi
Slide 18: DAVIO 2 Safety Comparable with Intravitreal Anti-VEGF Therapies
In DAVIO 2, the Safety Profile of EYP-1901 was Comparable with the Safety Profile of Intravitreal Anti-VEGF Therapies ©2023 EyePoint Pharmaceuticals, Inc. All Rights Reserved. *Multiple occurrences of the same event in one individual counted only once. In the AVENUE study, 214 (81.7%) participants e
Slide 19: EYP-1901 Continues to Show Favorable Safety Across Multiple Trials
©2023 EyePoint Pharmaceuticals, Inc. All Rights Reserved. Data as of Nov. 7th 2023 data cut 1-Data are preliminary pending study completion and final report. SAE, serious adverse event Summary: DAVIO (Phase 1): 17 patients treated DAVIO 2 (Phase 2)1: 102 patients treated PAVIA (Phase 2)1: ~51 patien
Slide 20: Reduction in Treatment Burden Supports Maintenance Treatment
Clinically Meaningful Reduction in Treatment Burden Supports EYP-1901 as a Maintenance Treatment For Wet AMD ©2023 EyePoint Pharmaceuticals, Inc. All Rights Reserved. *Normalized PRELIMINARY DATA – PENDING FINAL ANALYSIS EYP-1901 2mg EYP-1901 3mg Mean number of injections week 8 through week 32 0.55
Slide 21: Meaningful Reduction in Treatment Burden vs Aflibercept Control
EYP-1901 Demonstrated a Meaningful Reduction in Treatment Burden vs. the Aflibercept Control Arm ©2023 EyePoint Pharmaceuticals, Inc. All Rights Reserved. PRELIMINARY DATA – PENDING FINAL ANALYSIS. EYP-1901 2mg EYP-1901 3mg Aflibercept 2mg q8W Mean number of injections week 8 through week 32 0.55 0.
Slide 22: Clinically Meaningful Supplement-Free Rates
EYP-1901 Demonstrated Clinically Meaningful Supplement-Free Rates ©2023 EyePoint Pharmaceuticals, Inc. All Rights Reserved. PRELIMINARY DATA – PENDING FINAL ANALYSIS EYP-1901 2MG EYP-1901 3mg Supplement-Free Rates 65% 88% of eyes had 0 or only 1 supplemental injections 64% 83% of eyes had 0 or only
Slide 23: Nearly Two-Thirds of Eyes Supplement-Free Up to Six Months
Nearly Two-Thirds of Eyes Treated with EYP-1901 were Supplement-Free up to Six Months After a Single Injection ©2023 EyePoint Pharmaceuticals, Inc. All Rights Reserved. *First visit patients are eligible to be rescued **Month 8 represents 6 months post EYP-1901 injection PRELIMINARY DATA – PENDING F
Slide 24: Stable Anatomy via OCT in EYP-1901 Arms
Stable Anatomy via OCT in EYP-1901 Arms EYP-1901 2mg EYP-1901 3mg Aflibercept 2mg q8W Baseline CST (mean) 262.9 267.0 265.7 Change in OCT at Week 32 vs. Baseline + 15.1 microns + 10.6 microns + 5.4 microns Difference vs. Aflibercept Control + 9.7 microns + 5.2 microns NA ©2023 EyePoint Pharmaceutica
Slide 25: Strong Anatomic Control with OCT Change Below 10 microns
Data from DAVIO 2 Suggests Strong Anatomic Control with OCT Change Below 10 microns at Week 32 Compared to the Aflibercept Control ©2023 EyePoint Pharmaceuticals, Inc. All Rights Reserved. *Month 8 represents 6 months after first EYP-1901 injection PRELIMINARY DATA – PENDING FINAL ANALYSIS MEAN CHAN
Slide 26: DAVIO 2 Sub-Group Analysis of Patients Supplement-Free Up to 6 Months
©2023 EyePoint Pharmaceuticals, Inc. All Rights Reserved. Phase 2 DAVIO 2 Sub-Group Analysis of Patients Anti-VEGF Supplement-Free Up to 6 Months
Slide 27: Numerical Superiority in BCVA in Supplement-Free Sub-Group
©2023 EyePoint Pharmaceuticals, Inc. All Rights Reserved. +1.9* +2.4* +1.8* *Blended week 28 and week 32 change vs. baseline CI, Confidence Interval PRELIMINARY DATA – PENDING FINAL ANALYSIS EYP-1901 Demonstrated Numerical Superiority in Change in BCVA in Sub-Group Analysis of Patients Supplement-Fr
Slide 28: Strong Anatomic Control in Patients with No Supplement
Strong Anatomic Control in Patients with No Supplement Up to Month 8 with OCT Change Below 10 microns Compared to the Aflibercept Control ©2023 EyePoint Pharmaceuticals, Inc. All Rights Reserved. PRELIMINARY DATA – PENDING FINAL ANALYSIS Sub-Group Analysis of Patients Supplement-Free Up to Six Month
Slide 29: EYP-1901 Phase 2 DAVIO 2 Met All Primary and Secondary Endpoints
©2023 EyePoint Pharmaceuticals, Inc. All Rights Reserved. 1. As of November 7, 2023 data cut *vs. mean number of injections normalized 6 months prior to screening PRELIMINARY DATA – PENDING FINAL ANALYSIS Endpoint DAVIO 2 Topline DAVIO 2 Lower Limit (as included in November deck) Mean change in BCVA
Slide 30: Preliminary Phase 3 Pivotal Trial Overview
©2023 EyePoint Pharmaceuticals, Inc. All Rights Reserved. Preliminary Phase 3 Pivotal Trial Overview A NON-INFERIORITY TRIAL VERSUS AN AFLIBERCEPT CONTROL
Slide 31: DAVIO 2 Data Supports Advancement to Non-Inferiority Phase 3 Trials
Positive DAVIO 2 Data Supports Advancement to Non-Inferiority Phase 3 Pivotal Trials in Wet AMD ©2023 EyePoint Pharmaceuticals, Inc. All Rights Reserved. DAVIO 2 and Phase 3 Pivotal trials plans were informed by Type C meeting with FDA and consistent with subsequent wet AMD draft guidance for non-in
Slide 32: EYP-1901 Wet AMD Phase 3 Trial Concept
©2023 EyePoint Pharmaceuticals, Inc. All Rights Reserved. EYP-1901 Wet AMD Non-Inferiority Phase 3 Trial Concept: Randomized, Double-Masked, Aflibercept Control – 12 Month Endpoint Screening Day 1 Wk 4 Wk 8 Wk 12 Wk 16 Wk 20 Wk 24 Wk 28 Wk 32 Wk 36 Wk 40 Wk 44 Wk 48 Wk 52 Wk 56 Wk 60-76 Wk 80 Wk 84-
Slide 33: EYP-1901 in NPDR – Phase 2 PAVIA Clinical Trial
©2023 EyePoint Pharmaceuticals, Inc. All Rights Reserved. EYP-1901: vorolanib in Durasert E™ NON-PROLIFERATIVE DIABETIC RETINOPATHY (NPDR) – Phase 2 PAVIA clinical trial
Slide 34: Phase 2 PAVIA Clinical Trial Design in NPDR
©2023 EyePoint Pharmaceuticals, Inc. All Rights Reserved. DRSS – diabetic retinopathy severity score EYP-1901 DOSING VISIT SCHEDULED SHAM INJECTION -D21 to –D5 D1 W4 W12 W24 W36 W48 EYP-1901 2mg low dose EYP-1901 3mg high dose Control Sham RANDOMIZATION EYP-1901 1⁰ ENDPOINT UNMASK DATA Moderately se
Slide 35: PAVIA Masked Safety Summary
©2023 EyePoint Pharmaceuticals, Inc. All Rights Reserved. 1- As of October 1, 2023 data cut off Key findings: No drug-related ocular SAEs No drug-related systemic SAEs Two ocular SAEs, deemed not EYP-1901 related by investigators: Hemorrhagic posterior vitreous detachment (PVD) in a study eye eight-
Slide 36: Phase 2 VERONA Clinical Trial in Diabetic Macular Edema
©2023 EyePoint Pharmaceuticals, Inc. All Rights Reserved. EYP-1901: vorolanib in Durasert E™ Phase 2 VERONA clinical trial IN Diabetic Macular Edema (DME)
Slide 37: Phase 2 VERONA Clinical Trial Design
Phase 2 VERONA Clinical Trial is a Randomized, Open-Label, Aflibercept Controlled Trial with a Single EYP-1901 Injection EYP-1901 dosing Visit Scheduled aflibercept injection Sham injection EYP-1901 low dose (n=10) EYP-1901 high dose (n=10) Aflibercept 2mg single injection (n=5) Supplemental Anti-VE
Slide 38: VERONA Primary Endpoint: Time to Supplemental Injection
VERONA Primary Endpoint: Time to Supplemental Injection up to Week 24 – Supplement Criteria ©2023 EyePoint Pharmaceuticals, Inc. All Rights Reserved. 1. vs. best on study measurement; 2. as measured by Spectral domain OCT (SD-OCT) BCVA, best corrected visual acuity; CST, central subfield thickness S
Slide 39: EYP-2301: Razuprotafib in Durasert E
©2023 EyePoint Pharmaceuticals, Inc. All Rights Reserved. EYP-2301: razuprotafib in Durasert E™ A sustained delivery tie-2 agonist for severe retinal diseases
Slide 40: EYP-2301 Being Developed as Sustained Delivery Treatment for Serious Retinal Diseases
EYP-2301: Razuprotafib in Durasert E™ is Being Developed as a Sustained Delivery Treatment for Serious Retinal Diseases ©2023 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 Jan 1;
Slide 41: Solid balance sheet and cash runway through Phase 3 topline data
©2023 EyePoint Pharmaceuticals, Inc. All Rights Reserved. Solid balance sheet and cash runway through topline data of Phase 3 trials for EYP-1901 in wet AMD Strong Cash Position Over $330M of cash and investments on December 31, 2023 $230M equity financing completed December 5, 2023 Multiple key dat
Slide 42: Continued Execution And Well Funded Through Key EYP-1901 Milestones
Continued Execution And Well Funded Through Key EYP-1901 Milestones ©2023 EyePoint Pharmaceuticals, Inc. All Rights Reserved. EYP-1901 Corporate ✓ DAVIO 2 enrollment complete Q1 2023 ✓ PAVIA enrollment complete Q2 2023 ✓ DAVIO 2 topline data December 2023 ✓ VERONA - DME Phase 2 Trial initiation Q1 2
Slide 43: J.P. Morgan Healthcare Conference Presentation
J.P. Morgan Healthcare Conference Presentation January 10, 2024 Jay Duker, M.D. President and CEO ©2023 EyePoint Pharmaceuticals, Inc. All Rights Reserved.
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