8-K
false000131410200013141022024-01-102024-01-10

 

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): January 10, 2024

 

 

EyePoint Pharmaceuticals, Inc.

(Exact name of Registrant as Specified in Its Charter)

 

 

Delaware

000-51122

26-2774444

(State or Other Jurisdiction
of Incorporation)

(Commission File Number)

(IRS Employer
Identification No.)

 

 

 

 

 

480 Pleasant Street

 

Watertown, Massachusetts

 

02472

(Address of Principal Executive Offices)

 

(Zip Code)

 

Registrant’s Telephone Number, Including Area Code: (617) 926-5000

 

 

(Former Name or Former Address, if Changed Since Last Report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:


Title of each class

 

Trading
Symbol(s)

 


Name of each exchange on which registered

Common Stock, par value $0.001

 

EYPT

 

The Nasdaq Global Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

 


 

Item 2.02. Results of Operations and Financial Condition.

On January 10, 2024, EyePoint Pharmaceuticals, Inc. (the “Company”) posted an updated investor presentation on its website at www.eyepointpharma.com which included certain financial information as of December 31, 2023. A copy of the presentation is filed herewith as Exhibit 99.1 and is incorporated by reference herein.

Item 8.01 Other Events.

On January 10, 2024, the Company issued a press release announcing the first patient dosed in phase 2 of the clinical trial of EYP-1901 for the treatment of diabetic macular edema ("DME"). A copy of the press release is attached hereto as Exhibit 99.2 and incorporated by reference herein.

 

The information set forth in Item 2.02 of this Current Report on Form 8-K is incorporated by reference into this Item 8.01.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

 

Exhibit No.

Description

99.1

99.2

 

Investor Presentation of EyePoint Pharmaceuticals, Inc. dated January 10, 2024

Press Release of EyePoint Pharmaceuticals, Inc. dated January 10, 2024

104

 

Cover Page Interactive Data File (embedded within the inline XBRL document)

 


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

 

 

EYEPOINT PHARMACEUTICALS, INC.

 

 

 

 

Date:

January 10, 2024

By:

/s/ George O. Elston

 

 

 

George O. Elston
Executive Vice President and Chief Financial Officer

 


Slide 1

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 ©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 assumptions. All statements that address activities, events or developments that we intend, expect, plan or believe may occur in the future, including but not limited to statements about the sufficiency of our existing cash resources through topline data for the Phase 3 DAVIO 3 clinical trials; our expectations regarding the timing and clinical development of our product candidates, including EYP-1901 and EYP-2301; the potential for EYP-1901 as a novel sustained delivery treatment for serious eye diseases, including wet age-related macular degeneration, non-proliferative diabetic retinopathy and diabetic macular edema; and our longer term financial and business goals and expectations, are forward-looking statements. Some of the factors that could cause actual results to differ materially from the anticipated results or other expectations expressed, anticipated or implied in our forward-looking statements are risks and uncertainties inherent in our business including, without limitation: the effectiveness and timeliness of clinical trials, and the usefulness of the data; the timeliness of regulatory approvals; our ability to access needed capital; termination or breach of current and future license agreements; our dependence on contract research organizations, co-promotion partners, and other outside vendors and service providers; effects of guidelines, recommendations and studies; protection of our intellectual property and avoiding intellectual property infringement; retention of key personnel; product liability; industry consolidation; compliance with environmental laws; manufacturing risks; risks and costs of international business operations; volatility of our stock price; possible dilution; absence of dividends; the impact of instability in general business and economic conditions, including changes in inflation, interest rates and the labor market; and other factors described in our filings with the Securities and Exchange Commission. We cannot guarantee that the results and other expectations expressed, anticipated or implied in any forward-looking statement will be realized. A variety of factors, including these risks, could cause our actual results and other expectations to differ materially from the anticipated results or other expectations expressed, anticipated or implied in our forward-looking statements. Should known or unknown risks materialize, or should underlying assumptions prove inaccurate, actual results could differ materially from past results and those anticipated, estimated or projected in the forward-looking statements. You should bear this in mind as you consider any forward-looking statements. Our forward-looking statements speak only as of the dates on which they are made. We do not undertake any obligation to publicly update or revise our forward-looking statements even if experience or future changes makes it clear that any projected results expressed or implied in such statements will not be realized.


Slide 3

©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 wet AMD First Phase 3 trial in wet AMD planned to initiate in 2H 2024 Topline Phase 2 data in NPDR anticipated in Q2 2024 First patient dosed in Phase 2 trial in DME; topline data in DME anticipated in Q1 2025 EYP-2301 – razuprotafib, a patented TIE-2 agonist for serious retinal diseases in Durasert E™ Durasert® - proven, safe IVT drug delivery technology Bioerodible Durasert E™ and non-erodible formulations Safely administered to thousands of patient eyes across four FDA approved products with non-erodible formulations Strong Balance Sheet Over $330M of cash and investments on December 31, 2023 $230M equity financing completed December 5, 2023 Cash runway through topline data for Phase 3 wet AMD pivotal trials Committed to developing therapeutics to improve the lives of patients with serious retinal diseases


Slide 4

©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 Phase 1 Phase 2 Phase 3 Next Milestone EYP-1901 – vorolanib in Durasert E™ (tyrosine kinase inhibitor) Wet AMD NPDR DME EYP-2301 – razuprotafib in Durasert E™ (TIE-2 agonist) serious retinal diseases Complement inhibition GA EOP2 Mtg with FDA, Phase 3 initiation in 2H 2024 Topline data in Q2 2024 Topline data in Q1 2025 Pre-clin tox and PK data in 2024 Potential product candidate in 2024 trial underway trial planned non-clinical single-dose, 6-month maintenance therapy 160 patients complete with positive Phase 2 topline data single-dose, 9-month treatment 77 patients single-dose, 6-month treatment Pipeline Represents Multibillion Dollar Product Opportunities


Slide 5

©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 shell: YUTIQ®1  ILUVIEN®1 RETISERT®2 VITRASERT®2 Durasert E™: bioerodible Insert consists of drug embedded within a bioerodible matrix Designed to deplete drug load before matrix fully erodes TECHNOLOGY DURASERT® 1- licensed to Alimera; 2 – licensed to Bausch and Lomb Durasert - Intravitreal Sustained-Release Drug Delivery


Slide 6

©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 selective pan–VEGF receptor inhibition Composition of matter patent into 2037 (potential patent term extension to 2042) Demonstrated neuroprotection in a validated retinal detachment animal model Blocks PDGF which may lead to antifibrotic benefit Reduced off-target binding - does not inhibit TIE-2 at clinically relevant doses Vorolanib Brings a Potential New MOA to the Treatment of VEGF-Mediated Retinal Diseases by Blocking all Isoforms of VEFG and PDGF


Slide 7

©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 efficacy data in wet AMD from Phase 1 DAVIO and Phase 2 DAVIO 2 clinical trials Favorable safety data in ongoing Phase 2 clinical trials Shipped and stored at ambient temperature EYP-1901: Receptor Binding Vorolanib In Bioerodible Durasert E™ IVEGF – vascular endothelial growth factor: AMD – age related macular degeneration;


Slide 8

©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

©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 a Type C meeting with FDA Design: Multi-center, randomized, double-masked trial in patients with previously treated wet AMD Anti-VEGF supplement criteria: 5 letter loss with 75 microns of new fluid Other criteria 10 letter loss due to wet AMD 100 microns new fluid x 2 visits New retinal hemorrhage from wet AMD Investigator discretion Primary outcome: difference in mean change in BCVA from Day 1 to Week 28 and 32 (blended) Key secondary endpoints: safety, reduction in treatment burden, percent of eyes supplement-free up to six months and anatomical results


Slide 10

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 Aflibercept 2mg q8W n=54 RANDOMIZATION REQUIRED AFLIBERCEPT INJECTION VISIT VISIT SCHEDULED EYP-1901 DOSE AFLIBERCEPT q8W EYP-1901/AFLIBERCEPT 1⁰ ENDPOINT BLEND W28 AND W32; UNMASK W32 SHAM INJECTION FOR MASKING *Aflibercept on-label control required by FDA


Slide 11

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 letters (range) 73.4 (41-85) 73.9 (52-84) 74.9 (46-85) Mean CST, μm (range) 265.7 (178-348) 267.0 (192-400) 262.9 (186-345) Median length of time for wet AMD diagnosis prior to screening, months (range) 28.1 (2.4-273.6) 24.2 (2.4-168.0) 28.1 (2.4-145.2) Mean # of injections normalized to 12 months prior to screening (range) 9.5 (2.0-12.0) 10.1 (2.0-13.0) 10.0 (2.0-13.3) PRELIMINARY DATA – PENDING FINAL ANALYSIS


Slide 12

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 - 0.4 letters Secondary: Favorable safety profile1 No EYP-1901 related SAEs Secondary: Reduction in Treatment Burden vs. 6 mos prior 89% 85% Secondary: Reduction in Treatment Burden vs. aflibercept 83% 79% Secondary: Supplement-free up to 6 months 65% 88% of eyes had 0 or only 1 supplemental injections 64% 83% of eyes had 0 or only 1 supplemental injections Secondary: Anatomical control vs aflibercept +9.7um +5.2um


Slide 13

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 + 1.0 letters + 0.9 letters + 1.3 letters Difference vs. Aflibercept Control - 0.3 letters - 0.4 letters NA Statistics NI (95% CI) NI (95% CI) NA *Blended week 28 and week 32 1 – AAO 2022 presentation, Paolo Lanzetta, on behalf of the PULSAR study investigators NI, Non-inferior; CI, Confidence Interval PRELIMINARY DATA – PENDING FINAL ANALYSIS Non-inferiority Margin = - 4.5 letters per FDA guidance In the Pulsar trial, HD Eylea (16-week 8mg arm) change in BCVA vs. 2mg Eylea was -1.4 letters1


Slide 14

©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 and week 32 change vs. baseline **Month 8 represents 6 months after first EYP-1901 injection 1 – AAO 2022 presentation, Paolo Lanzetta, on behalf of the PULSAR study investigators CI, Confidence Interval PRELIMINARY DATA – PENDING FINAL ANALYSIS In the Pulsar trial, HD Eylea (16-week 8mg arm) change in BCVA vs. 2mg Eylea was -1.4 letters1


Slide 15

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 2- as deemed by the investigator No reported EYP-1901-related ocular or systemic SAEs Four ocular SAEs reported in a study eye – none deemed EYP-1901 related2 >97% of AEs reported were mild (Grade 1 or 2) and generally expected with IVT No insert migration into the anterior chamber No retinal occlusive vasculitis Low patient discontinuation rate of 4% up to week 32 No discontinuations were related to EYP-1901 treatment


Slide 16

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 FINAL ANALYSIS 1- As of November 7, 2023 data cut 2- As deemed by the investigator Four ocular SAEs reported in study eyes – all determined to be unrelated to EYP-19012 Retinal detachment at week 1; one week after initial aflibercept injection, prior to EYP-1901 injection Bacterial endophthalmitis at week 32; two days after anterior chamber paracentesis in a patient using CPAP Non-infectious endophthalmitis at week 29; seven days after aflibercept injection Retinal tears at week 36; four weeks after aflibercept injection


Slide 17

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 investigator N (%) Aflibercept 2mg q8W (n=54) EYP-1901 2mg (n=53) EYP-1901 3mg (n=53) Study eyes with AEs 20 (37.0%) 30 (56.6%) 29 (54.7%) Study eyes with ≥1 treatment-related ocular AE1 0 (0.0%) 0 (0.0%) 0 (0.0%) Ocular AEs reported in ≥5% of study eyes: Worsening wet AMD 2 (3.7%) 7 (13.2%) 6 (11.3%) Conjunctival hemorrhage 2 (3.7%) 6 (11.3%) 3 (5.7%) Vitreous floaters 0 (0%) 3 (5.7%) 4 (7.5%) Retinal hemorrhage 1 (1.9%) 1 (1.9%) 5 (9.4%) Cataract 3 (5.6%) 2 (3.8%) 3 (5.7%) Eye pain 1 (1.9%) 2 (3.8%) 3 (5.7%) Vitreous detachment 2 (3.7%) 3 (5.7%) 2 (3.8%) Subretinal fluid 1 (1.9%) 3 (5.7%) 0 (0.0%)


Slide 18

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 experienced at least one adverse event during the study. In the STAIRWAY study, 54 (76.1%) of participants experiences at least one adverse event during the study. **Data reflects treatment-emergent AEs only. Overall AEs not reported. VABYSMO (faricimab) HD EYLEA (aflibercept 8mg) N (%) AVENUE*1 N=262 STAIRWAY*2 N=71 CANDELA3 (Treatment-emergent AEs only)** N=106 Study eyes with ocular AEs 125 (47.7%) 28 (39.4%) 40 (37.7%) Study eyes with serious ocular AEs 5 (1.9%) 0 (0.0%) 3 (2.8%) Sources: 1. Jama Ophthalmology, Safety and Efficacy of Different Doses and Regimens of Faricimab vs Ranibizumab in Neovascular Age-Related Macular Degeneration, Jayashree Sahni, MBBS, MD; Pravin U. Dugel, MD; Sunil S. Patel, MD, PhD; et al. 2. Jama Ophthalmology, Efficacy of Every Four Monthly and Quarterly Dosing of Faricimab vs Ranibizumab in Neovascular Age-Related Macular Degeneration, Arshad M. Khanani, MD, MA; Sunil S. Patel, MD, PhD; Philip J. Ferrone, MD; et al. 3. Jama Ophthalmology, Effect of High-Dose Intravitreal Aflibercept, 8 mg, in Patients With Neovascular Age-Related Macular Degeneration, Charles C. Wykoff, MD, PhD1; David M. Brown, MD1; Kimberly Reed, OD2; et al.


Slide 19

©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 patients treated ~170 treated patients with a minimum of six months post EYP-1901 injection with no EYP-1901-related ocular or systemic SAE’s EYP-1901 Continues to Show a Favorable Safety Profile Across Multiple Clinical Trials


Slide 20

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 0.71 Mean number of injections 6 months prior to screening* 5.07 4.98 Reduction in treatment burden vs. 6 months prior (%) 89% 85%


Slide 21

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 0.71 3.32 Reduction in treatment burden vs. aflibercept control (%) 83% 79% NA


Slide 22

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 1 supplemental injections Percent of Patients Supplement-Free up to Six Months After Administration of EYP-1901


Slide 23

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 FINAL ANALYSIS 100% Summary of Supplement-Free Rates by Month 100%


Slide 24

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 Pharmaceuticals, Inc. All Rights Reserved. PRELIMINARY DATA – PENDING FINAL ANALYSIS Based on market research, CST within approximately 30-50 microns is an acceptable range for the potential adoption of a new treatment The standard deviation on the measure is 10 microns; anything under 10 microns is within the margin of error


Slide 25

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 CHANGE in CST +10.6 um +15.1 um +5.4 um EYP-1901 2mg + 9.7 um EYP 1901 3mg + 5.2 um Diff vs. Aflibercept Control


Slide 26

©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

©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-Free Up to 6 Months Sub-Group Analysis of Patients Supplement-Free Up to Six Months MEAN CHANGE IN BCVA FROM BASELINE EYP-1901 2mg + 0.6* EYP 1901 3mg + 0.1* Diff vs. Aflibercept Control


Slide 28

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 Months MEAN CHANGE in CST +8.6 um +15.0 um +8.0 um Diff vs. Aflibercept Control EYP-1901 2mg + 7.0 um EYP 1901 3mg + 0.6 um


Slide 29

©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 vs. aflibercept control - 0.3 letters (EYP-1901 2mg) - 0.4 letters (EYP-1901 3mg) Statistically non-inferior (CI 95%) < - 3.0 letters (potentially underpowered) Safety No reported EYP-1901-related ocular SAEs1 No reported EYP-1901- related systemic SAEs1 Favorable safety profile Reduction in treatment burden 89% (EYP-1901 2mg)* 85% (EYP-1901 3mg)* 50% or better Supplement-free rate 65% (EYP-1901 2mg), 88% 0-1 supplements 64% (EYP-1901 3mg), 83% 0-1 supplements 50% or better Mean change in CST on OCT + 15.1 microns (EYP-1901 2mg) + 10.6 microns (EYP-1901 3mg) Within ~30 microns EYP-1901 Phase 2 DAVIO 2 Clinical Trial Met All Primary and Secondary Endpoints


Slide 30

©2023 EyePoint Pharmaceuticals, Inc. All Rights Reserved. Preliminary Phase 3 Pivotal Trial Overview A NON-INFERIORITY TRIAL VERSUS AN AFLIBERCEPT CONTROL


Slide 31

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-inferiority clinical trials The Phase 3 non-inferiority trial design is similar to DAVIO 2 except: Reinjection of EYP-1901 at six-month intervals Primary efficacy endpoint at 12 months blended (basis of NDA submission) Safety monitored for up to 24 months; NDA submission planned with 12-month safety data Aflibercept control arm dosed for initial 12 months only Two registration trials: parallel US and OUS DAVIO 2 statistics with high CI suggests meaningfully smaller sized and lower cost Phase 3 trials EYP-1901 dosing likely 1 or 2 inserts (vs 2 or 3 in DAVIO 2) Initiation of the first pivotal trial anticipated in 2H 2024 FDA, Food and Drug Administration; NDA, New Drug Application; OUS, outside the United States; CI, confidence interval


Slide 32

©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 84-92 Wk 96 EOS EYP-1901 low dose EYP-1901 high dose Aflibercept q8W Primary Endpoint Blend Wk 52 and 56 Randomization Aflibercept 2mg q8W Key Endpoints Primary endpoint: Mean change in BCVA at W52 and W56 Non-inferiority margin 4.5 letters Key secondary endpoints: Safety Anti-VEGF injection burden reduction Supplement-free rate up to week 56 CST change EYP-1901 IVT dosing Per Protocol Scheduled Visits/Assessments Per Protocol aflibercept intravitreal injection Sham injection


Slide 33

©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

©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 severe to severe NPDR patients enrolled Primary endpoint is >2 step DRSS improvement score at week 36 Secondary endpoints: Reduction in vision- threatening complications DME occurrence and/or proliferative disease Retinal ischemia Safety Fully enrolled with 77 patients; topline data anticipated in Q2 2024 EYP-1901 Phase 2 PAVIA Clinical Trial is a Randomized Double-Masked, EYP-1901 Single Injection with Sham Control as a 9-Month Treatment in NPDR


Slide 35

©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-weeks after dosing Macular edema leading to vision loss in the non-study fellow eye PAVIA Masked Safety Summary 1 Topline data anticipated in Q2 2024


Slide 36

©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 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-VEGF injection based on prespecified criteria Potential 6-month treatment in previously treated DME patients Objectives: Evaluate the safety and efficacy of two doses of EYP-1901 in the DME patient population Collect dose-ranging data to inform future clinical trials Primary endpoint: time to supplemental anti-VEGF injection up to week 24 Secondary endpoints: Change in BCVA vs. aflibercept control, stable anatomical outcome as measured by OCT, DRSS over time Primary endpoint -D28 to -D7 D1 W4 W8 W12 W16 W20 W24 First patient dosed; topline data anticipated in Q1 2025


Slide 38

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 Starting at Week 4: Reduction in BCVA ≥10 letters due to DME1 Reduction in BCVA of 5-9 letters and >75 microns of new fluid at two consecutive visits1 Increase of ≥100 microns of new fluid vs. Baseline (Day 1)2 Investigator discretion Starting at Week 12: Lack of 10% reduction in CST compared to Baseline (Day 1)


Slide 39

©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: 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; 3. Shen et al. JCI, 2014; 124:4564; 4. Campochiaro et al. Ophthalmology, 2016; 123:1722-1730 Tie-2 activation combined with VEGF inhibition has the potential to enhance efficacy and extend durability1 of treatment In the retina, activated TIE-2 controls endothelial cell proliferation, barrier function and intercellular contacts, stabilizing vessels and the blood-retinal barrier2 Razuprotafib (f/k/a AKB-9778) delivered subcutaneously was previously studied demonstrating preclinical and clinical proof of concept in posterior segment disease 3,4 EYP-2301 targets vascular endothelial protein tyrosine phosphatase (VE-PTP) to promote TIE-2 activation and maintain vascular stability in the retina P P EYP-2301 Blood vessel lumen Intracellular space VE-PTP ANG2


Slide 41

©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 data and value inflection points within the next 12 months


Slide 42

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 2024 EOP2 meeting with FDA for wet AMD March/April 2024 PAVIA topline data Q2 2024 First wet AMD Phase 3 trial initiation 2H 2024 VERONA topline data Q1 2025 ✓ YUTIQ transacted for $82.5M plus royalties Q2 2023 ✓ Debt retired and cash runway extended into 2025 Q2 2023 ✓ Oversubscribed $230M equity financing closed December 2023


Slide 43

J.P. Morgan Healthcare Conference Presentation January 10, 2024 Jay Duker, M.D. President and CEO ©2023 EyePoint Pharmaceuticals, Inc. All Rights Reserved.

EX-99.2

https://cdn.kscope.io/bb4398c5d095557626872adb54b2f2c5-img97631278_0.jpg 

Exhibit 99.2

 

 

EyePoint Pharmaceuticals Announces First Patient Dosed in Phase 2 VERONA Clinical Trial of EYP-1901 for the Treatment of Diabetic Macular Edema

 

WATERTOWN, Mass., January 10, 2024 (GLOBE NEWSWIRE) – EyePoint Pharmaceuticals, Inc. (NASDAQ: EYPT), a company committed to developing and commercializing therapeutics to improve the lives of patients with serious retinal diseases, today announced that the first patient has been dosed in the Phase 2 VERONA clinical trial of EYP-1901 for diabetic macular edema (DME). EYP-1901 is an investigational sustained delivery therapy containing vorolanib, a selective tyrosine kinase inhibitor formulated in bioerodible Durasert E.

 

“Dosing the first patient in the Phase 2 VERONA trial represents another significant milestone in advancing our mission to improve the lives of patients with serious retinal diseases. DME is a common sight-threatening complication of diabetes that can lead to severe vision loss. It represents the second diabetic eye disease indication that we are evaluating for potential treatment using EYP-1901,” said Jay Duker, M.D., Chief Executive Officer of EyePoint Pharmaceuticals. “There is a significant need for differentiated and longer-acting treatments for DME patients, as the current standard of care requires frequent intravitreal injections that are burdensome and can result in under-treatment. We are encouraged by the growing body of clinical data for EYP-1901 and we are optimistic that EYP-1901 has the potential to change the current treatment paradigm for DME with topline data expected in Q1 2025.”

Dr. Duker continued “We look forward to announcing additional milestones for the EYP-1901 clinical programs with topline data from the Phase 2 PAVIA clinical trial in non-proliferative diabetic retinopathy expected in the second quarter of 2024 and the initiation of the first Phase 3 pivotal trial in wet age-related macular degeneration (wet AMD) anticipated in the second half of 2024.”

VERONA is a randomized, controlled, single-masked, Phase 2 trial of EYP-1901 in DME patients previously treated with a standard-of-care anti-VEGF therapy. The three-arm trial is expected to enroll approximately 25 patients assigned to one of two intravitreal doses of EYP-1901 or an aflibercept control. The primary efficacy endpoint of the VERONA trial is time to first supplemental aflibercept injection up to 24 weeks based on established supplement criteria. Secondary endpoints include safety, change in best corrected visual acuity (BCVA), change in central subfield thickness (CST) as measured by optical coherence tomography (OCT), and change in diabetic retinopathy severity scale (DRSS) over time. More information about the trial is available at clinicaltrials.gov (identifier: NCT06099184).

 

About Diabetic Macular Edema

 

Diabetic macular edema (DME) is the leading cause of vision loss in people with type 1 and type 2 diabetes. DME results when damaged blood vessels leak fluid into the macula, the central portion of the retina responsible for the sharp vision needed for routine tasks such as driving or reading. This resulting retinal swelling can cause blurred vision and may lead to severe vision loss or even blindness. DME is a common form of sight-threatening retinopathy in people with diabetes, with approximately 28 million people afflicted worldwide. As the prevalence of diabetes continues to grow, an increased number of people will be affected by diabetic eye diseases such as DME. The current standard of care for patients experiencing DME include intravitreal injections of short-acting anti-VEGF biologics, corticosteroids, or laser


https://cdn.kscope.io/bb4398c5d095557626872adb54b2f2c5-img97631278_0.jpg 

photocoagulation which can become a burden on patients, caregivers, and physicians due to the longevity of the disease.

 

About EYP-1901

 

EYP-1901 is being developed as a potential paradigm-altering treatment for patients suffering from VEGF-mediated retinal diseases. EYP-1901 delivers vorolanib, a selective and patent-protected tyrosine kinase inhibitor (TKI) formulated in a solid bioerodible insert using EyePoint’s proprietary sustained-release Durasert E technology. Vorolanib brings a new mechanistic approach to the treatment of VEGF-mediated retinal diseases as a pan-VEGF receptor inhibitor, inhibiting all VEGF receptors. Further, in an in-vivo model of retinal detachment, vorolanib demonstrated neuroprotection and antifibrotic benefits. EYP-1901 is shipped and stored at ambient temperature and is administered with a standard intravitreal injection in the physician's office. EYP-1901 is immediately bioavailable, featuring an initial burst of drug, followed by near constant zero-order release kinetics for approximately nine months.

 

Positive data from both the Phase 1 DAVIO and Phase 2 DAVIO 2 clinical trials of EYP-1901 in wet AMD demonstrated clinically meaningful efficacy data with stable visual acuity and OCT, and a favorable safety profile. Further, the recent DAVIO 2 data demonstrated an impressive treatment burden reduction of approximately 88% at six-months, with over 80% of patients supplement-free or receiving only one supplemental anti-VEGF injection through up to 6 months. The data from the DAVIO 2 clinical trial supports the advancement of the wet AMD program to Phase 3 pivotal trials which are anticipated to initiate in the second half of 2024.

 

EYP-1901 is also being studied in non-proliferative diabetic retinopathy and diabetic macular edema. The Phase 2 PAVIA trial in NPDR is fully enrolled with topline data anticipated in the second quarter of 2024.

 

About EyePoint Pharmaceuticals

 

EyePoint Pharmaceuticals (Nasdaq: EYPT) is a clinical-stage biopharmaceutical company committed to developing and commercializing therapeutics to help improve the lives of patients with serious retinal diseases. The Company's pipeline leverages its proprietary bioerodible Durasert E technology for sustained intraocular drug delivery. The Company’s lead product candidate, EYP-1901, is an investigational sustained delivery treatment for VEGF-mediated retinal diseases combining vorolanib, a selective and patent-protected tyrosine kinase inhibitor with Durasert E. Additional pipeline programs include EYP-2301, a promising TIE-2 agonist, razuprotafib, f/k/a AKB-9778, formulated in Durasert E to potentially improve outcomes in serious retinal diseases. The proven Durasert® drug delivery technology has been safely administered to thousands of patient eyes across four U.S. FDA approved products. EyePoint Pharmaceuticals is headquartered in Watertown, Massachusetts.

 

Vorolanib is licensed to EyePoint exclusively by Equinox Sciences for the localized treatment of all ophthalmic diseases outside of China, Macao, Hong Kong and Taiwan.

 

Forward Looking Statements

EYEPOINT PHARMACEUTICALS SAFE HARBOR STATEMENTS UNDER THE PRIVATE SECURITIES LITIGATION ACT OF 1995: To the extent any statements made in this press release deal with information that is not historical, these are forward-looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements regarding the use of proceeds for the offering and other statements identified by words such as “will,” “potential,”


https://cdn.kscope.io/bb4398c5d095557626872adb54b2f2c5-img97631278_0.jpg 

“could,” “can,” “believe,” “intends,” “continue,” “plans,” “expects,” “anticipates,” “estimates,” “may,” other words of similar meaning or the use of future dates. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause EyePoint’s actual results to be materially different than those expressed in or implied by EyePoint’s forward-looking statements. For EyePoint, this includes uncertainties regarding the timing and clinical development of our product candidates, including EYP-1901 and EYP-2301; the potential for EYP-1901 as a novel sustained delivery treatment for serious eye diseases, including wet age-related macular degeneration (wet AMD) and non-proliferative diabetic retinopathy (NPDR) and diabetic macular edema (DME); the effectiveness and timeliness of clinical trials, and the usefulness of the data; the timeliness of regulatory approvals including potential U.S. Food and Drug Administration (FDA) regulatory approval of EYP-1901 and EYP-2301; the success of current and future license agreements; our dependence on contract research organizations, co-promotion partners, and other outside vendors and service providers; the success of Durasert® as a drug delivery platform in FDA approved products; product liability; industry consolidation; compliance with environmental laws; risks and costs of international business operations; volatility of stock price; possible dilution; absence of dividends; the impact of general business and economic conditions; protection of our intellectual property and avoiding intellectual property infringement; retention of key personnel; manufacturing risks; and other factors described in our filings with the Securities and Exchange Commission. We cannot guarantee that the results and other expectations expressed, anticipated or implied in any forward-looking statement will be realized. A variety of factors, including these risks, could cause our actual results and other expectations to differ materially from the anticipated results or other expectations expressed, anticipated or implied in our forward-looking statements. Should known or unknown risks materialize, or should underlying assumptions prove inaccurate, actual results could differ materially from past results and those anticipated, estimated or projected in the forward-looking statements. You should bear this in mind as you consider any forward-looking statements. Our forward-looking statements speak only as of the dates on which they are made. EyePoint undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

 

 

Investors:

Christina Tartaglia
Stern IR
Direct: 212-698-8700

christina.tartaglia@sternir.com

 

Media Contact

Amy Phillips

Green Room Communications

Direct: 412-327-9499

aphillips@greenroompr.com