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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
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Date of Report (Date of earliest event reported) March 04, 2025 |
EyePoint Pharmaceuticals, Inc.
(Exact name of Registrant as Specified in Its Charter)
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Delaware |
000-51122 |
26-2774444 |
(State or Other Jurisdiction
of Incorporation) |
(Commission File Number) |
(IRS Employer
Identification No.) |
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480 Pleasant Street |
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Watertown, Massachusetts |
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02472 |
(Address of Principal Executive Offices) |
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(Zip Code) |
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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:
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Title of each class
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Trading
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Name of each exchange on which registered
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Common Stock, par value $0.001 |
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EYPT |
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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 8.01 Other Events.
On March 4, 2025, EyePoint Pharmaceuticals, Inc. posted an updated investor presentation on its website at www.eyepointpharma.com. A copy of the presentation is filed herewith as Exhibit 99.1 and is incorporated by reference herein.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
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.
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EYEPOINT PHARMACEUTICALS, INC. |
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Date: |
March 4, 2025 |
By: |
/s/ George O. Elston |
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George O. Elston
Executive Vice President and Chief Financial Officer |
TD Cowen Healthcare Conference Presentation March 4, 2025 Jay Duker, M.D. President and CEO ©2025 EyePoint Pharmaceuticals, Inc. All Rights Reserved. Confidential Exhibit 99.1
The Leader in Sustained Release Drug Delivery for Retinal Disease ©2025 EyePoint Pharmaceuticals, Inc. All Rights Reserved. Durasert® features robust safety profile across multiple indications Compelling DAVIO 2 data enabling rapid enrollment of global Phase 3 pivotal trials for DURAVYU in wet AMD Strong balance sheet with ~$370M in cash and equivalents1; cash runway into 2027 post Phase 3 readouts in 2026 DURAVYU™: vorolanib - best-in-class, patent protected TKI in Durasert E™ sustained delivery technology Highly positive Phase 2 data for DURAVYU in DME 1. As of December 31, 2024. Unaudited estimate, inclusive of net proceeds from October 2024 equity financing. MOA, mechanism of action; wet AMD, wet age-related macular degeneration; DME, diabetic macular edema 1 2 3 4 5
Multiple Programs Targeting Significant Market Opportunities ©2025 EyePoint Pharmaceuticals, Inc. All Rights Reserved. Source: Internal estimates based on publicly reported actual and estimated sales data. wet AMD, wet age-related macular degeneration; DME, diabetic macular edema; NPDR, non-proliferative diabetic retinopathy, RVO, retinal vein occlusion Wet AMD and DME Represent >80% of the Total Branded Market
©2025 EyePoint Pharmaceuticals, Inc. All Rights Reserved. wet AMD, wet age-related macular degeneration; DME, diabetic macular edema; PK, pharmacokinetic; GA, geographic atrophy Pipeline Leveraging Durasert E™ Drug Delivery Technology trial underway non-clinical Durasert E™ Programs Indication Discovery Pre-Clin Phase 1 Phase 2 Phase 3 Anticipated Next Milestone DURAVYU™ – (vorolanib intravitreal insert) (f/k/a EYP-1901) Wet AMD DME EYP-2301 – razuprotafib (TIE-2 agonist) serious retinal diseases Enrollment completion in 2H 2025 FDA EOP2 anticipated 2Q 2025 Pre-clin tox and PK data PIVOTAL TRIALS UNDERWAY Positive 24-Week Data Evaluating additional pipeline opportunities
IVT, intravitreal; TIE2, tyrosine-protein kinase receptor TIE-2; VEGF(R), vascular endothelial growth factor (receptor). DURAVYUTM (EYP-1901): Vorolanib in Durasert ETM Durasert E™ Bioerodible, sustained IVT drug delivery Vorolanib Patented and potent receptor tyrosine kinase inhibitor (TKI): selectively inhibits all VEGF signaling Endothelial cell TIE2 Blood vessel stability VEGFR1 VEGFR2 VEGFR3 VEGF Receptors Angiogenesis DURAVYU Vorolanib bound to target receptors Vorolanib Durasert E™ No delay – reaches target tissues at therapeutic levels within hours of administration No fluctuation – delivered as a continuous dose with zero-order kinetics No free-floating drug – fully eluted before matrix bioerosion No cold storage – shipped and stored at ambient temperature Controlled release over a period of at least 6 months ©2024 EyePoint Pharmaceuticals, Inc. All Rights Reserved. Not drawn to scale, for illustrative purposes only. Insert is 1/5000 of vitreous volume.
©2025 EyePoint Pharmaceuticals, Inc. All Rights Reserved. DURAVYU Demonstrated Positive Efficacy and Favorable Safety Profile Across Multiple Clinical Trials and Indications 1. Data as of January 16, 2025. Preliminary data pending final analysis. Wet AMD, wet age-related macular degeneration; NPDR, non-proliferative diabetic retinopathy; DME, diabetic macular edema; SAEs, serious adverse events; BCVA, best-correct visual acuity; OCT, optical coherence tomography. Clinical Trial Indication Safety Key Efficacy Outcomes DAVIO wet AMD No DURAVYU related ocular or systemic SAEs Stable BCVA and CST 74% reduction in treatment burden DAVIO 2 wet AMD Statistically non-inferior BCVA vs on-label aflibercept >80% reduction in treatment burden Stable anatomy (CST) PAVIA NPDR Stable or prevention of worsening disease severity VERONA1 DME Primary endpoint met Meaningful, immediate and sustained improvement in BCVA and OCT DURAVYU Has Been Evaluated in Over 190 Patients to Date Across Multiple Indications
©2024 EyePoint Pharmaceuticals, Inc. All Rights Reserved. LUGANO/LUCIA Phase 3 Pivotal Trials in wet AMD NON-INFERIORITY VERSUS AN AFLIBERCEPT CONTROL
©2024 EyePoint Pharmaceuticals, Inc. All Rights Reserved. Ongoing DURAVYU Phase 3 Trials in Wet AMD Supported by Phase 2 DAVIO 2 Results - All Primary and Secondary Endpoints Met Endpoint 2mg 3mg R Primary: Non-inferior change in BCVA vs. aflibercept - 0.3 letters - 0.4 letters R Secondary: Favorable safety profile1 No DURAVYU-related SAEs R Secondary: Reduction in treatment burden vs. 6 mos. prior 89% 85% R Secondary: Reduction in treatment burden vs. aflibercept 82% 76% R Secondary: Supplement-free up to 6 months 63% 88% of eyes had 0 or 1 supplemental injections 63% 83% of eyes had 0 or 1 supplemental injections R Secondary: Anatomical control vs. aflibercept +12.4um +5.2um
Phase 3 Pivotal Trials Designed to Evaluate Non-Inferiority of DURAVYU vs. Aflibercept Control ©2025 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 BLEND W52 AND W56; UNMASK W56 SHAM INJECTION FOR MASKING W36 W40 W44 W48 W52 W56 W60-W76 W80 W96 EOS AFLIBERCEPT Q8W Sham injection For Masking Supplemental anti-VEGF injection based on strict criteria AFLIBERCEPT load DURAVYU DURAVYU DURAVYU DURAVYU Full enrollment for LUGANO/LUCIA expected 2H 2025
Phase 3 Clinical Trials for DURAVYU in wet AMD Seeing Exceptional Enrollment Rates Driven by Significant Investigator and Patient Enthusiasm ©2025 EyePoint Pharmaceuticals, Inc. All Rights Reserved. June 2024 Final Phase 3 protocols October 2024 First patient in LUGANO trial dosed December 2024 First patient in LUCIA trial dosed 2H 2025 Expected full enrollment of both Phase 3 pivotal trials Top line data for both Phase 3 pivotal trials anticipated in 2026 January 2025 LUGANO trial ~1/3 enrolled; LUCIA exceeding expectations 2026 Topline data for pivotal program in wet AMD February 2025 LUGANO trial >50% enrolled; LUCIA exceeding expectations
State-Of-The-Art cGMP Manufacturing Facility in Northbridge Ready to Support DURAVYU through Phase 3 and Global Commercial Production ©2025 EyePoint Pharmaceuticals, Inc. All Rights Reserved. cGMP, current good manufacturing practices; FDA, Federal Drug Administration; EMA, European Medicines Agency; cGMP, current good manufacturing practice Located in Northbridge, MA Built to US FDA and EU EMA standards DURAVYU registration batches in-motion to support future NDA filing Built to EYPT specifications by landlord preserving upfront cash investment 40,000sf+ commercial manufacturing site
©2025 EyePoint Pharmaceuticals, Inc. All Rights Reserved. Phase 2 VERONA Clinical Trial in DME 24 Week results DME, diabetic macular edema Data as of January 16, 2025. Preliminary data pending final analysis.
Diabetic Macular Edema: Large Market Opportunity with Significant Unmet Need for More Durable Treatments ©2025 EyePoint Pharmaceuticals, Inc. All Rights Reserved. 1. William R. Rowley, Clement Bezold, Yasemin Arikan, et al. Diabetes 2030: Insights from Yesterday, Today and Future Trends. PubMed Central. 2017 PMCID: PMC5278808 PMID: 27124621 . 2. Russel Lazarus. Optometrists Network. Guide to Eye Conditions; Diabetic Macular Edema. 3. DelveInsights DME Market Report -2030. 4. Monique A. Rose, Meri Vukicevic, Konstandina Koklanis. Adherence of patients with diabetic macular oedema to intravitreal injections: A systematic review. PubMed 2020 PMID: 32829485 DOI: 10.1111/ceo.13845. 5. Lee, R., Wong, T.Y. & Sabanayagam, C. Epidemiology of diabetic retinopathy, diabetic macular edema and related vision loss. Eye and Vis 2, 17 (2015). https://doi.org/10.1186/s40662-015-0026-2. 6. Nagda D, Mitchell W, Zebardast N. The functional burden of diabetic retinopathy in the United States. Graefes Arch Clin Exp Ophthalmol. 2021;259(10):2977–2986. https://doi.org/10.1007/s00417-021-05210-3. Patients in the US with diabetes by 20301 Global branded market by 20303 Delayed/missed treatment visits4 54.9M 25% up to 51% $3.9B Develop DME within 10 years2 Vision loss from missed injection5 5-6 letters By 2050, diabetes-related vision loss is expected to cost 500 million US dollars annually6
DURAVYU is Uniquely Positioned to Provide an Improved DME Treatment Paradigm Compared to Current Anti-VEGF Therapies ©2025 EyePoint Pharmaceuticals, Inc. All Rights Reserved. 24-Month Treatment Regimens for DME: 2–4-month dosing 1-4-month dosing Anti-VEGF SoC DURAVYU™ (vorolanib intravitreal insert)* 2-month dosing 1-month dosing 6-month dosing *Potential positioning for DURAVYU, if approved, based on Phase 3 protocol for wet AMD. SoC, standard of care
©2025 EyePoint Pharmaceuticals, Inc. All Rights Reserved. DME, diabetic macular edema; VEGF, vascular endothelial growth factor; BCVA, best corrected visual acuity; OCT, optical coherence tomography; CST, central subfield thickness DURAVYU dosing Visit Scheduled aflibercept injection Sham injection DURAVYU 1.3mg (n=10) DURAVYU 2.7mg (n=11) Aflibercept 2mg single injection (n=6) Supplemental Anti-VEGF injection based on prespecified criteria Objectives: Evaluate the safety and efficacy of DURAVYU in patients with active DME (CST >325μm) Collect dose-ranging data to inform Phase 3 clinical trials Primary endpoint: time to supplemental anti-VEGF injection up to week 24 Key Secondary endpoints: safety, change in BCVA vs. aflibercept control and anatomical control (CST) Primary endpoint -D28 to -D7 D1 W4 W8 W12 W16 W20 W24 VERONA Phase 2 Clinical Trial - Randomized, Open-Label, Aflibercept Controlled as a Potential Treatment for DME
VERONA Clinical Trial Supplement Criteria ©2025 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; PRN, pro re nata; 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 (unique supplementation criteria incorporated due to PRN design of trial): Lack of 10% reduction in CST compared to Baseline (Day 1)
VERONA: Phase 2 Clinical Trial Met Primary and Key Secondary Endpoints Data supports DURAVYU as a Potential Treatment for DME with improvement in vision and anatomy with superior dosing intervals ©2025 EyePoint Pharmaceuticals, Inc. All Rights Reserved. DURAVYU 2.7mg: Primary endpoint achieved - extended time to first supplemental injection vs. aflibercept control Early and sustained BCVA improvement = +7.1 letters Early and sustained CST improvement = -76 microns DURAVYU SAFETY Results: No ocular or systemic DURAVYU-related SAEs No cases of: Impaired vision Endophthalmitis Retinal vasculitis (occlusive or non-occlusive) Intraocular inflammation (IOI) Insert migration DME, diabetic macular edema; BCVA, best-corrected visual acuity; CST, central subfield thickness; SAEs, serious adverse events. Data as of January 16, 2025. Preliminary data pending final analysis.
©2025 EyePoint Pharmaceuticals, Inc. All Rights Reserved. Phase 2 VERONA Clinical Trial in DME – 24-Week Results DME, diabetic macular edema Data as of January 16, 2025. Preliminary data pending final analysis.
Primary Endpoint Met - Patients Treated with DURAVYU had a Greater Proportion of Supplement-Free Eyes vs. Aflibercept Control at 24-Weeks ©2025 EyePoint Pharmaceuticals, Inc. All Rights Reserved. Data as of January 16, 2025. Preliminary data pending final analysis. 2.7mg DURAVYU reduced treatment burden by over two-thirds Summary of Cumulative Supplement-Free Rates 100% 100% 100% Supplement-free rates up to Week 24* *Supplement-free rates up to Week 24 reflect rates prior to any treatments given during the Week 24 visit to account for planned six-month re-dosing protocol for Phase 3 pivotal trial (patients not eligible for supplement when getting re-dosed).
©2025 EyePoint Pharmaceuticals, Inc. All Rights Reserved. Single DURAVYU 2.7mg Treatment Demonstrated Clinically Meaningful Improvement in BCVA; Supports Noninferiority in Pivotal Trial BCVA, best-corrected visual acuity; VA, visual acuity Data as of January 16, 2025. Preliminary data pending final analysis. MEAN CHANGE IN BCVA FROM BASELINE +7.1 +7.3 DURAVYU 2.7mg -0.2 Mean Change in BCVA vs Aflibercept +6.9 Early and sustained VA improvement
©2025 EyePoint Pharmaceuticals, Inc. All Rights Reserved. Excluding a Single Outlier Patient, DURAVYU 2.7mg Improved +10 Letters vs. Baseline; Nearly +3 Letters Better than Control BCVA, best-corrected visual acuity; VA, visual acuity Data as of January 16, 2025. Preliminary data pending final analysis. MEAN CHANGE IN BCVA FROM BASELINE Excluding Outlier Patient +10.1 +7.3 DURAVYU 2.7mg (ex outlier) +2.8 Mean Change in BCVA vs Aflibercept Outlier patient missed multiple visits including the Week 20 visit resulting in vision loss of >20 letters at the Week 24 visit.
©2025 EyePoint Pharmaceuticals, Inc. All Rights Reserved. DURAVYU 2.7mg Demonstrated Improved and Controlled Anatomy with 74% More Drying than Aflibercept Control CST: central subfield thickness Data as of January 16, 2025. Preliminary data pending final analysis. Source: Independent reading center results available as of the full 24-week data cut. MEAN CHANGE IN CST FROM BASELINE -75.9 um -43.7 um Mean Change in CST vs Aflibercept -71.1 um DURAVYU 2.7mg -32.2 um
©2025 EyePoint Pharmaceuticals, Inc. All Rights Reserved. Phase 2 VERONA Clinical Trial in DME Sub-Group Analysis Of Patients Supplement-free at 24 Weeks DME, diabetic macular edema Data as of January 16, 2025. Preliminary data pending final analysis.
©2025 EyePoint Pharmaceuticals, Inc. All Rights Reserved. Sub-Group Analysis of Supplement-Free Patients Demonstrated Eyes Treated with DURAVYU 2.7mg had Better Visual Acuity vs. Control BCVA, best-corrected visual acuity; VA, visual acuity Data as of January 16, 2025. Preliminary data pending final analysis. MEAN CHANGE IN BCVA FROM BASELINE +10.3 +3.0 Mean Change in BCVA vs Aflibercept +6.5 DURAVYU 2.7mg +7.3 Supplement-free is defined as patients who did not receive a supplement at any point during the study.
©2025 EyePoint Pharmaceuticals, Inc. All Rights Reserved. Sub-Group Analysis of Supplement-Free Patients* Demonstrated Eyes Treated with DURAVYU 2.7mg had Significantly More and Maintained Drying than Control CST: central subfield thickness Data as of January 16, 2025. Preliminary data pending final analysis. Source: Independent reading center results available as of the full 24-week data cut. MEAN CHANGE IN CST FROM BASELINE -117.4 um -43.7 um Mean Change in CST vs Aflibercept -30.8 um DURAVYU 2.7mg -73.7 um Supplement-free is defined as patients who did not receive a supplement at any point during the study.
©2025 EyePoint Pharmaceuticals, Inc. All Rights Reserved. DURAVYU Treated Eyes were Well-Controlled at 24 Weeks versus Aflibercept Control in Supplement-Free Patient Sub-Group Absence of DME is defined as CST reading ≤325 microns at 24 weeks. Data as of January 16, 2025. Preliminary data pending final analysis. DME, diabetic macular edema Percentage of Patients with Absence of DME at 24 Weeks
VERONA Clinical Trial Case Study 1 - Rapid Drying with Improved Vision After Single DURAVYU Treatment and No Supplementation ©2025 EyePoint Pharmaceuticals, Inc. All Rights Reserved. Screening BCVA 50 Aflibercept + 2.7mg DURAVYU -12 -11 -10 -9 -8 -7 -6 -5 -4 -3 -2 -1 Day1 1 2 3 4 5 6 Eylea Eylea Vabysmo washout BCVA 46 Day 1 BCVA 67 Month 4 BCVA 66 Month 6 Month 1 BCVA 65 Day 1 (2.7mg DURAVYU insert) Case 1: SOC Anti-VEGF Injections Before and After Treatment
VERONA Clinical Trial Case Study 2 - Continued Drying at Week 24 with Improved VA After Single DURAVYU Treatment and No Supplementation ©2025 EyePoint Pharmaceuticals, Inc. All Rights Reserved. Screening BCVA 72 Aflibercept + 2.7mg DURAVYU -12 -11 -10 -9 -8 -7 -6 -5 -4 -3 -2 -1 Day1 1 2 3 4 5 6 Avastin Vabysmo washout BCVA 73 Day 1 BCVA 80 Month 4 BCVA 80 Month 6 Month 1 BCVA 74 Day 1 (2.7mg DURAVYU insert) Case 2: SOC Anti-VEGF Injections Before and After Treatment
VERONA Results Strengthen Robust DURAVYU Safety Database ©2025 EyePoint Pharmaceuticals, Inc. All Rights Reserved. SAE, serious adverse event Data as of January 16, 2025. Preliminary data pending final analysis. No reported DURAVYU-related ocular SAEs or systemic SAEs No cases of: Endophthalmitis Retinal vasculitis (occlusive or non-occlusive) Insert migration Intraocular inflammation (IOI) No discontinuations >190 patients treated with DURAVYU to date with no DURAVYU-related SAEs
VERONA: Phase 2 Clinical Trial Summary ©2025 EyePoint Pharmaceuticals, Inc. All Rights Reserved. Data as of January 16, 2025. Preliminary data pending final analysis. Primary endpoint met for both DURAVYU doses Demonstrated immediate and clinically meaningful results without a full load of aflibercept Significant improvement in vision and anatomic results paired with a meaningful reduction in treatment burden Sub-group analysis of supplement-free eyes demonstrated results are driven by treatment with DURAVYU and not by supplemental injections Continued favorable safety and tolerability
On Track for Continued Execution And Well-Funded Through Key Anticipated DURAVYU Milestones ©2025 EyePoint Pharmaceuticals, Inc. All Rights Reserved. DME, diabetic macular edema; EOP2, End of Phase 2; wet AMD, wet age-related macular degeneration; SAB, Scientific Advisory Board DURAVYU™ Corporate ✓ Positive EOP2 meeting with FDA for wet AMD April 2024 ✓ PAVIA for NPDR topline data May 2024 ✓ DAVIO 2 12-month data Jue 2024 ✓ Positive interim VERONA data October 2024 ✓ First patient dosed – LUGANO October 2024 ✓ First patient dosed – LUCIA December 2024 ✓ VERONA Phase 2 DME full topline data February 2025 FDA EOP2 meeting for DME Q2 2025 Full enrollment of both pivotal Phase 3 trials in wet AMD 2H 2025 ✓ Expanded SAB with world-renowned retina specialists April 2024 ✓ R&D Day - NYC June 2024 ✓ Fred Hassan appointed to Board of Directors September 2024 ✓ Northbridge manufacturing facility grand opening October 2024 ✓ Reginald Sanders, MD appointed to Board of Directors January 2025
TD Cowen Healthcare Conference Presentation March 4, 2025 Jay Duker, M.D. President and CEO ©2025 EyePoint Pharmaceuticals, Inc. All Rights Reserved. Confidential
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EyePoint Pharmaceuticals (NASDAQ:EYPT)
과거 데이터 주식 차트
부터 2월(2) 2025 으로 3월(3) 2025
EyePoint Pharmaceuticals (NASDAQ:EYPT)
과거 데이터 주식 차트
부터 3월(3) 2024 으로 3월(3) 2025
