WATERTOWN, Mass., Dec. 17, 2025 (GLOBE NEWSWIRE) -- EyePoint, Inc. (Nasdaq: EYPT), a company committed to developing and commercializing innovative therapeutics to improve the lives of patients with serious retinal diseases, today announced that Jay S. Duker, M.D., President and Chief Executive Officer of EyePoint will present at the 44th Annual J.P. Morgan Healthcare Conference in San Francisco on Tuesday, January 13, 2026 at 7:30 a.m. PT/10:30 a.m. ET. A webcast and subsequent archived replay of the prese ...

Core Insights - EyePoint Pharmaceuticals announced positive recommendations from the independent Data Safety Monitoring Committee (DSMC) for its pivotal Phase 3 trials, LUGANO and LUCIA, evaluating DURAVYU for wet age-related macular degeneration (wet AMD) [1][2][3] - The trials are on track to report topline data in mid-2026, with no changes to the protocol recommended by the DSMC [1][2] - DURAVYU is designed as a sustained-delivery treatment, potentially reducing the treatment burden for patients with wet AMD [5][9] Company Overview - EyePoint Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing innovative therapeutics for serious retinal diseases [11] - The lead product candidate, DURAVYU, combines vorolanib, a selective tyrosine kinase inhibitor, with proprietary Durasert E technology for sustained drug release [11][13] - The company has a history of developing approved drugs and aims to improve patient lives while creating long-term value [12] Clinical Trials - The LUGANO and LUCIA trials are randomized, double-masked, aflibercept-controlled, non-inferiority Phase 3 trials with over 900 patients enrolled [3][9] - The primary endpoint is non-inferiority in best corrected visual acuity (BCVA) change at weeks 52 and 56 compared to baseline [3][9] - Secondary endpoints include safety, treatment burden reduction, and anatomical results measured by optical coherence tomography (OCT) [3][9] Treatment Context - Wet AMD is a leading cause of vision loss in individuals over fifty, requiring continuous treatment to maintain visual function [4] - Current standard-of-care treatments are administered on average every two months, posing a significant burden on patients and healthcare systems [4] - DURAVYU aims to address these challenges by providing a sustained-release option that could reduce the frequency of treatments [5][9] Product Details - DURAVYU is a solid bioerodible insert designed to release a constant therapeutic dose for at least six months [5][6] - Vorolanib, the active ingredient, has shown no ocular safety signals in previous trials and targets multiple pathways involved in retinal diseases [7][8] - The product is positioned to potentially offer a flexible dosing regimen for physicians treating wet AMD [9][10]

Core Viewpoint - EyePoint Pharmaceuticals has granted stock options to new employees as inducement awards outside its 2023 Long-Term Incentive Plan, in compliance with NASDAQ Listing Rule 5635(c)(4) [1][2]. Company Overview - EyePoint Pharmaceuticals, Inc. (NASDAQ:EYPT) is a clinical-stage biopharmaceutical company focused on developing innovative therapeutics for serious retinal diseases [3]. - The company's lead product candidate, DURAVYU™, is a sustained delivery treatment combining vorolanib, a selective tyrosine kinase inhibitor, with next-generation bioerodible Durasert E™ technology [3]. - DURAVYU is currently undergoing evaluation in two Phase 3 pivotal trials for wet age-related macular degeneration (wet AMD), with topline data for the LUGANO trial expected in mid-2026 [3]. - The first patient dosing in pivotal Phase 3 clinical trials for diabetic macular edema (DME) is anticipated in the first quarter of 2026 [3]. Stock Options Details - The company granted stock options to purchase up to 31,000 shares of common stock to seven new employees on November 14, 2025 [2]. - The exercise price for the options is set at $11.58 per share, which is the closing price of EyePoint's common stock on the grant date [2]. - The options have a ten-year term and vest over four years, with 25% vesting on the first anniversary and the remainder vesting in equal monthly installments over the following three years [2].

Summary of EyePoint Pharmaceuticals Conference Call Company Overview - **Company**: EyePoint Pharmaceuticals (NasdaqGM:EYPT) - **Focus**: Phase 3 development in sustained drug delivery for wet age-related macular degeneration (AMD) and diabetic macular edema (DME) [1][2] Key Points Industry and Market Position - EyePoint is a leader in sustained drug delivery to the back of the eye, with a focus on wet AMD and DME [2] - The company has a strong balance sheet with approximately $350 million in cash, providing a runway into Q4 2027 [3] Clinical Trials and Pipeline - **Wet AMD Trials**: Two phase 3 trials (LUGANO and LUCIA) are fully enrolled, with top-line data expected mid-2026 [10][22] - **DME Trials**: First patients to be dosed in Q1 2026, with simultaneous readouts expected in Q4 2027 [3][19] - **EYP2301**: A pipeline asset in preclinical stage [3] Technology and Drug Delivery - **DuraCert Technology**: Proven in four FDA-approved products, with a new delivery system (Duravyu) consisting of 94% drug and 6% matrix [4][5] - **Vorolanib**: A multi-mechanism action (MOA) drug that blocks VEGF receptors and inflammation through JAK1, showing sustained drug levels for at least six months [4][6][8] Efficacy and Safety - Previous trials (one phase 1 and three phase 2) demonstrated excellent efficacy and safety, with no ocular or systemic serious adverse events (SAEs) reported [5][6] - Vorolanib showed over 50% reduction in IL-6 activity, indicating potential for better outcomes in DME and wet AMD [9][16] Competitive Landscape - EyePoint's approach may capture significant market share if non-inferiority to existing treatments (Eylea and Lucentis) is demonstrated, with potential for better visual outcomes and reduced treatment burden [26][27] - Other companies, such as Kodiak Sciences and Genentech, are also exploring IL-6 blockage, indicating a competitive environment [16] Commercial Strategy - The company is focused on commercial scale-up and success, with a new facility in Northbridge, Massachusetts, capable of producing hundreds of thousands of inserts annually [24] - Physician enthusiasm for the treatment is high, with expectations that a successful trial could shift retinal practice towards EyePoint's TKI approach [25][26] Regulatory Considerations - The FDA has provided clear guidelines for non-inferiority trials, requiring on-label controls for both wet AMD and DME [34] - EyePoint plans to leverage safety data from wet AMD trials to inform DME trials, potentially reducing the number of patients needed for safety assessments [21][22] Future Outlook - The company is positioned to be first in class and best in class in the two largest retinal indications, with robust phase 1 and phase 2 efficacy and safety data [22] - Full enrollment for DME trials is expected in the second half of next year, with a focus on achieving better visual acuity and reduced treatment burden [22][23] Additional Insights - The company emphasizes the importance of sustained release options for chronic diseases, which may improve patient compliance and outcomes [29] - The potential for neuroprotective and antifibrotic effects from vorolanib could further differentiate EyePoint's offerings in the market [27][28]

Stifel 2025 Healthcare Conference November 12, 2025 Jay Duker, MD President and CEO © 2025 EyePoint. All Rights Reserved. Legal Disclaimers 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, are fo ...

Summary of EyePoint Pharmaceuticals FY Conference Call Company Overview - **Company**: EyePoint Pharmaceuticals (NasdaqGM:EYPT) - **Mission**: To improve patients' lives through enhanced treatment of retinal diseases, focusing on drug delivery systems [6][5][4] Key Trials and Developments - **Pivotal Trials**: - Two pivotal trials for wet age-related macular degeneration (AMD): Lugano Trial and Lugia Trial, both fully enrolled with over 400 patients each [6][7] - Expected readout for Lugano Trial in mid-2026 and Lugia Trial shortly thereafter [6] - Phase three trials for diabetic macular edema (DME) named COMO and COPRI, with patient dosing starting in Q1 2026 [7] - **Drug Mechanism**: Vorolanib, the drug in focus, exhibits both anti-VEGF and anti-inflammatory effects by blocking the JAK1 receptor, which is significant for conditions like diabetic macular edema and wet AMD [9] Enrollment and Study Design - **Rapid Enrollment**: The rapid enrollment in the wet AMD trials was attributed to strong phase two data and the patient-centric design of the studies [11][10] - **Patient Population**: The phase three study includes both previously treated and naive patients, with expectations of better outcomes in naive patients [14][13] Safety and Efficacy Expectations - **Safety Profile**: The safety results so far are consistent with prior trials, with no vision loss reported due to the drug insert [21][23] - **Efficacy Goals**: The aim is to be statistically non-inferior to Eylea, with hopes of achieving statistical superiority [20][19] Competitive Landscape - **Market Position**: EyePoint aims to differentiate itself from competitors like Vabysmo and Eylea by offering a different mechanism of action and a six-month dosing schedule [36][37] - **First-to-Market Advantage**: If approved, EyePoint will be the first to market with its sustained-release product, which is expected to be advantageous [38] Market Potential - **DME Market Size**: The DME market is approximately $3 billion in the U.S., representing about 35-40% of the overall market for retinal diseases [49][50] Regulatory and Global Strategy - **Regulatory Readiness**: EyePoint is preparing for a pre-approval inspection by the FDA and has a clear plan for NDA submission based on the results of the ongoing trials [33][31] - **Ex-U.S. Strategy**: The company plans to include European sites in its studies and is preparing for potential launch outside the U.S., with a focus on finding a global partner at the right time [50][51] Conclusion EyePoint Pharmaceuticals is positioned at a pivotal moment with multiple ongoing trials and a strong focus on innovative drug delivery for retinal diseases. The company is optimistic about its upcoming trial results and the potential market impact of its products.

Revenue Performance - Total revenues decreased by 91% to $966,000 for the three months ended September 30, 2025, compared to $10.5 million in the same period the prior year[90] - Product sales, net decreased by 12% to $582,000 for the three months ended September 30, 2025, primarily due to the automatic termination of the ANI CSA in Q2 2025[91] - License and collaboration agreement revenue decreased by 98% to $150,000 for the three months ended September 30, 2025, driven by the recognition of remaining deferred revenue related to the 2023 agreement for YUTIQ® product rights[92] - Total revenues for the nine months ended September 30, 2025, were $30.8 million, a decrease of $934,000 or 3% compared to the same period in 2024[101] - Product sales, net decreased by $1.1 million, or 46%, to $1.3 million for the nine months ended September 30, 2025, primarily due to the automatic termination of the ANI CSA[102] - Royalty income increased by $11.5 million, or 830%, to $12.9 million for the nine months ended September 30, 2025, mainly due to the recognition of deferred SWK royalty revenue[104] Expenses and Losses - Research and development expenses increased by 62% to $47.8 million for the three months ended September 30, 2025, compared to $29.5 million in the same period the prior year[90] - Total operating expenses increased by 46% to $63.0 million for the three months ended September 30, 2025, compared to $43.3 million in the same period the prior year[90] - Net loss increased by 103% to $59.7 million for the three months ended September 30, 2025, compared to a net loss of $29.4 million in the same period the prior year[90] - Net loss per share increased by 57% to $(0.85) for the three months ended September 30, 2025, compared to $(0.54) in the same period the prior year[90] - For the nine months ended September 30, 2025, the net loss was $164.4 million, an increase of $74.9 million compared to a net loss of $89.5 million for the same period in 2024[118] - Operating cash outflows for the nine months ended September 30, 2025 totaled $175.1 million, compared to $90.4 million for the same period in 2024, reflecting an increase of $84.7 million[119] Research and Development - DURAVYU™ is currently being evaluated in Phase 3 pivotal trials for wet AMD, with data readout expected to begin in mid-2026[85] - The first patient dosing for pivotal Phase 3 trials evaluating DURAVYU™ for DME is anticipated in Q1 2026[89] - Research and development expenses increased by $72.3 million, or 81%, to $161.8 million for the nine months ended September 30, 2025, attributed to ongoing DURAVYU™ Phase 3 clinical trials[106] Cash and Financing - The company has cash, cash equivalents, and investments totaling $204.0 million as of September 30, 2025, which, along with net proceeds of approximately $162.1 million from an equity financing, will fund operations into Q4 2027[80] - Cash, cash equivalents, and investments in marketable securities totaled $204.0 million as of September 30, 2025, expected to fund operations into the fourth quarter of 2027[115] - Net cash provided by investing activities for the nine months ended September 30, 2025 was $145.5 million, a significant increase of $266.6 million compared to a net cash outflow of $119.7 million in 2024[120] - Net cash provided by financing activities for the nine months ended September 30, 2025 totaled $6.7 million, a decrease of $5.6 million from $12.3 million in 2024[121] - The company issued 495,118 shares of Common Stock in 2025, raising $6.7 million through its ATM program[121] Operational Challenges - The company anticipates continued substantial operating losses for at least the next several years as it develops product candidates and seeks marketing approval[117] - Cash outflows related to changes in working capital for the nine months ended September 30, 2025 were $29.5 million, including $28.6 million of deferred revenue related to licensing agreements[118] - The company reported cash outflows of $29.5 million in working capital adjustments, reflecting ongoing operational challenges[118] - General and administrative expenses increased by $1.5 million, or 12%, to $14.5 million for the three months ended September 30, 2025, mainly due to an increase in contingent liability[98] - Interest income decreased by $1.1 million, or 32%, to $2.3 million for the three months ended September 30, 2025, driven by lower cash available for investment[99] - Non-cash expenses for the nine months ended September 30, 2025 included $21.1 million of stock-based compensation, compared to $28.8 million in 2024[119] - The company incurred $2.3 million for the purchase of property and equipment in 2025, compared to $3.7 million in 2024[120] - Deferred revenue related to the licensing of YUTIQ® product rights to ANI was $22.1 million in 2024, indicating a consistent revenue stream from licensing agreements[119]

Financial Data and Key Metrics Changes - For the quarter ended September 30, 2025, total net revenue was $1 million compared to $10.5 million for the same quarter in 2024, primarily due to the recognition of deferred revenue related to a prior year agreement [16] - Operating expenses for the quarter totaled $63 million, an increase from $43.3 million in the prior year, driven by clinical trial costs for ongoing phase three trials [17] - The net loss was $59.7 million, or $0.85 per share, compared to a net loss of $29.4 million, or $0.54 per share, in the prior year [17][18] - Cash and investments totaled $204 million as of September 30, 2025, down from $371 million as of December 31, 2024, but expected to fund operations into Q4 2027 [18] Business Line Data and Key Metrics Changes - Duraview is positioned to be the first to file and first to market among investigational sustained delivery programs for wet AMD and DME, with top-line data expected in mid-2026 [5][6] - Enrollment for the Lucia trial, a phase three trial for Duraview in wet AMD, was completed in July, with over 900 patients recruited across two trials [6] - The phase three DME program is set to begin with first patient dosing expected in Q1 2026, leveraging existing clinical trial infrastructure [11] Market Data and Key Metrics Changes - The global market for wet AMD and DME is currently valued at $10 billion and is expected to grow, dominated by monotherapy anti-VEGF biologics [8] - Current treatment options lead to a high burden of frequent injections, with many patients remaining undertreated [8][9] Company Strategy and Development Direction - The company aims to deliver innovation in wet AMD and DME through Duraview, a sustained-release TKI designed to improve treatment efficacy and reduce patient burden [9][10] - The manufacturing capability is being enhanced to support commercialization, with a GMP-compliant facility already producing registration batches [11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the differentiated clinical profile of Duraview and its potential to transform treatment paradigms in retinal diseases [5] - The company is well-capitalized to deliver phase three data in 2026 and advance its DME program [19] Other Important Information - The company completed a $172 million follow-on offering in October, enhancing its cash position [7][16] - Recent preclinical data showed Duraview's active ingredient, virolanib, inhibits both VEGF-mediated vascular permeability and IL-6-mediated inflammation, supporting its multi-mechanism of action [7][12] Q&A Session Summary Question: Market sizing for wet AMD population in the U.S. - Approximately 20% of wet AMD patients require monthly treatment, with 50% unable to extend beyond eight weeks even with newer agents [21][22] Question: Enrollment criteria for DME program - The DME program will enroll both treatment-naive and previously treated patients, using aflibercept as a control [25] Question: Use of blended endpoint in trials - The blended endpoint is used to reduce missing data and capture recovery in vision, which is common in clinical trials for wet AMD [27][29] Question: Differentiation in IL-6 inhibition - IL-6 plays a significant role in DME, and blocking both VEGF and IL-6 pathways could lead to improved outcomes compared to anti-VEGF-only approaches [31][34] Question: Statistical analysis plan for superiority testing - The analysis plan allows for testing superiority if non-inferiority is met, which could position Duraview as a premium medication [36][37]

Core Insights - EyePoint Pharmaceuticals reported a quarterly loss of $0.85 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.77, marking a surprise of -10.39% [1] - The company's revenues for the quarter were $0.97 million, significantly missing the Zacks Consensus Estimate by 85.07%, and down from $10.52 million a year ago [2] - EyePoint Pharmaceuticals has not surpassed consensus EPS estimates in the last four quarters and has only topped revenue estimates once during this period [2] Financial Performance - The company has shown a loss of $0.54 per share in the same quarter last year, indicating a deterioration in performance [1] - The current consensus EPS estimate for the upcoming quarter is -$0.74, with expected revenues of $0.25 million, while the estimate for the current fiscal year is -$3.06 on revenues of $30.69 million [7] Stock Performance - EyePoint Pharmaceuticals shares have increased by approximately 66.3% since the beginning of the year, outperforming the S&P 500, which gained 15.1% [3] - The stock currently holds a Zacks Rank of 3 (Hold), indicating it is expected to perform in line with the market in the near future [6] Industry Outlook - The Medical - Biomedical and Genetics industry, to which EyePoint Pharmaceuticals belongs, is currently in the top 40% of over 250 Zacks industries, suggesting a favorable outlook compared to lower-ranked industries [8] - The performance of EyePoint Pharmaceuticals may be influenced by the overall industry outlook, as research indicates that the top 50% of Zacks-ranked industries outperform the bottom 50% by more than 2 to 1 [8]

[Legal Disclaimers](index=2&type=section&id=Legal%20Disclaimers) [Summary of Disclaimers](index=2&type=section&id=Legal%20Disclaimers_Summary) This section outlines forward-looking statements, risks, and uncertainties inherent in the presentation, advising readers that actual results may differ materially from projections, referencing SEC filings for more detailed risk factors - The presentation contains forward-looking statements subject to risks and uncertainties, including clinical trial timing, regulatory approvals, manufacturing, and financial resources, as detailed in SEC filings (10-K, 10-Q)[5](index=5&type=chunk) [Company Overview & Pipeline](index=3&type=section&id=A%20Leader%20in%20Sustained%20Release%20Drug%20Delivery%20for%20Retinal%20Disease) [Company Highlights](index=3&type=section&id=A%20Leader%20in%20Sustained%20Release%20Drug%20Delivery%20for%20Retinal%20Disease_Highlights) EyePoint is a leader in sustained-release drug delivery for retinal diseases, with DURAVYU™ in Phase 3 for wet AMD and DME, supported by its Durasert® technology, experienced leadership, and a strong financial position - DURAVYU™ Phase 3 programs are underway for DME and wet AMD, with wet AMD data anticipated in **mid-2026**[7](index=7&type=chunk) - The company utilizes Durasert® delivery technology, which has a strong safety profile across multiple FDA-approved products[7](index=7&type=chunk) Financial Runway | Metric | Value | | :--- | :--- | | Cash & Equivalents (as of 9/30/25) | $200 million+ | | Runway | Into 2027 (beyond Phase 3 wet AMD data) | [Pipeline Programs](index=4&type=section&id=Pipeline%20Pursuing%20Large%20Market%20Opportunities) EyePoint's pipeline focuses on large market opportunities in retinal diseases, primarily with DURAVYU™ (vorolanib) in Phase 3 for wet AMD and DME, and EYP-2301 (razuprotafib) in pre-clinical development for other retinal diseases Durasert E™ Pipeline Programs | Program | Indication | Phase 1 | Phase 2 | Phase 3 | Anticipated Milestones | | :--- | :--- | :--- | :--- | :--- | :--- | | DURAVYU™ (vorolanib) | Wet AMD | | | LUGANO and LUCIA fully enrolled | LUGANO top mid-2026; LUCIA shortly after | | DURAVYU™ (vorolanib) | DME | | | Phase 3 planning underway | Phase 3 FPI | | EYP-2301 (razuprotafib) | Retinal diseases | | | | Tox and PK studies | - Current cash runway extends **into 2027**, covering significant milestones for DURAVYU in wet AMD[10](index=10&type=chunk) [Market Opportunity](index=5&type=section&id=DURAVYU%E2%84%A2%20is%20being%20evaluated%20in%20Wet%20AMD%20and%20DME) DURAVYU™ targets the two largest retinal disease markets, wet AMD and DME, which together represent **80%** of the **$12 billion+** global branded market for vascular retinal diseases - The global branded market for vascular retinal diseases is over **$12 billion**[11](index=11&type=chunk) Vascular Retinal Disease Market Share | Indication | Market Share (Billion $) | | :--- | :--- | | Wet AMD | $7 | | DME | $3 | | RVO | $2 | | NPDR | $0.3 | | **Total** | **$12.3+** | - Wet AMD and DME collectively account for **80%** of the branded market[12](index=12&type=chunk) [Durasert E™ Technology & DURAVYU Overview](index=6&type=section&id=Durasert%20E%E2%84%A2%3A%20The%20Next%20Generation%20in%20Sustained-Release%20Intravitreal%20Drug%20Delivery) [Durasert E™ Technology](index=6&type=section&id=Durasert%20E%E2%84%A2%3A%20The%20Next%20Generation%20in%20Sustained-Release%20Intravitreal%20Drug%20Delivery_Tech) Durasert E™ is a bioerodible, next-generation sustained-release intravitreal drug delivery technology with a proven safety profile, and DURAVYU, utilizing this technology, offers a novel multi-MOA, immediate therapeutic levels, and sustained drug release for six months or longer - Durasert E™ is a bioerodible technology with over **three decades** of innovation and proven safety across **four FDA-approved products**[14](index=14&type=chunk) - DURAVYU (vorolanib) offers a novel mechanism of action, inhibiting signaling from all VEGF isoforms at the receptor level[14](index=14&type=chunk) - DURAVYU achieves therapeutic levels **within hours** and provides consistent daily dosing with receptor inhibition for **≥6 months**[14](index=14&type=chunk) [DURAVYU Clinical Data Summary](index=7&type=section&id=DURAVYU%20Data%20Suggests%20Robust%20Efficacy%20Outcomes%20and%20a%20Strong%20Safety%20Profile%20Across%20Multiple%20Indications) DURAVYU has demonstrated robust efficacy and a strong safety profile across multiple indications in over **190 patients**, meeting primary endpoints in wet AMD and DME with disease control, fewer injections, and no safety signals DURAVYU Clinical Trial Results Summary | Trial | Phase | Indication | Key Outcomes | | :--- | :--- | :--- | :--- | | DAVIO | 1 | Wet AMD | Stable vision and OCT with 74% reduction in treatment burden | | DAVIO 2 | 2 | Wet AMD | Stable vision & strong anatomical control with >80% reduction in treatment burden | | PAVIA | 2 | NPDR | Prevented worsening of disease severity | | VERONA | 2 | DME | Rapid & sustained improvements in vision and anatomical control with fewer injections | - Primary endpoints were met in wet AMD & DME, showing disease control with fewer injections and a favorable safety and tolerability profile with no safety signals[17](index=17&type=chunk) [DURAVYU for Wet AMD](index=8&type=section&id=DURAVYU%20for%20Wet%20AMD) [Phase 3 Pivotal Program](index=9&type=section&id=DURAVYU%20in%20Wet%20AMD%3A%20LUGANO%20and%20LUCIA%3A%20Identical%20Phase%203%20Pivotal%20Trials%20Evaluating%20Non-inferiority%20vs%20On-label%20Aflibercept) The DURAVYU Phase 3 pivotal program for wet AMD, comprising identical LUGANO and LUCIA trials, is fully enrolled and on track, comparing DURAVYU **2.7mg q6M** against on-label aflibercept **2mg q8W**, with topline data for LUGANO expected **mid-2026** - Both LUGANO and LUCIA Phase 3 trials for wet AMD are fully enrolled, with topline **56-week data** for LUGANO expected in **mid-2026**[9](index=9&type=chunk)[22](index=22&type=chunk) - The trial design, informed by Phase 1 DAVIO and Phase 2 DAVIO 2 trials, has written alignment with the FDA, establishing a clear regulatory path[22](index=22&type=chunk) Phase 3 Wet AMD Trial Design (LUGANO & LUCIA) | Feature | Description | | :--- | :--- | | Design | Identical, non-inferiority pivotal trials | | Patients per trial | ~400 | | DURAVYU Dosing | 2.7 mg every 6 months (q6M) | | Comparator | Aflibercept 2 mg every 8 weeks (q8W) | | Primary Endpoint | Blended mean change in BCVA from baseline at Week 52 & Week 56 | | Supplemental Treatment | Anti-VEGF allowed based on strict prespecified criteria | [Commercial Manufacturing](index=11&type=section&id=Commercial%20Manufacturing%20Facility%20to%20Support%20DURAVYU%20through%20Potential%20NDA%20Approval%20and%20Commercial%20Launch) EyePoint has a **41,000 sq ft** commercial manufacturing facility in Northbridge, MA, built to FDA and EMA standards, with DURAVYU registration batches underway to support future NDA filing and commercial launch - A **41,000 sq ft** commercial manufacturing facility in Northbridge, MA, is built to US FDA and EU EMA standards[28](index=28&type=chunk) - DURAVYU registration batches are underway to support future NDA filing[28](index=28&type=chunk) [DURAVYU for DME: Market & Mechanism](index=12&type=section&id=DURAVYU%20for%20DME) [DME Market Opportunity & Unmet Needs](index=13&type=section&id=Diabetic%20Macular%20Edema%3A%20Large%20Market%20Opportunity%20with%20Significant%20Unmet%20Need%20for%20More%20Durable%20Treatments) Diabetic Macular Edema (DME) represents a large and growing market with significant unmet needs for more durable treatments and better inflammation control, as many patients still experience vision loss despite current therapies - **25%** of patients in the US with diabetes are projected to develop DME by **2030**[34](index=34&type=chunk) - The global branded market for DME is projected to reach **$10 billion** by **2030**[34](index=34&type=chunk) - There is an unmet need for effective, durable disease control and inflammation treatment in DME, as current therapies often lead to delayed/missed visits and vision loss[33](index=33&type=chunk)[37](index=37&type=chunk) [DME Pathogenesis: VEGF & Inflammation](index=15&type=section&id=DME%20is%20a%20Multifactorial%20Disease%20Driven%20by%20VEGF%20and%20Inflammation) DME is a multifactorial disease driven by both VEGF and inflammation, particularly IL-6, which plays a prominent role in its pathogenesis, and targeting both appears superior to VEGF blockage alone as IL-6 signaling via JAK kinases (especially JAK1) contributes to vascular leakage and neovascularization - DME is a multifactorial disease where VEGF suppression alone is insufficient; inflammation, particularly increased levels of IL-6, plays a key role[39](index=39&type=chunk)[41](index=41&type=chunk) - Dual inhibition of VEGF and IL-6 is critical for alleviating vascular leakage and inflammation, with IL-6 signaling occurring via activation of JAK kinases, especially JAK1[43](index=43&type=chunk)[45](index=45&type=chunk)[48](index=48&type=chunk) [Vorolanib's Multi-MOA in DME](index=17&type=section&id=DURAVYU%20for%20DME%3A%20Vorolanib%20provides%20multi-MOA%20functionality%20by%20inhibiting%20both%20VEGF%20and%20IL-6%20activation%20of%20inflammation) Vorolanib, the active ingredient in DURAVYU, provides multi-MOA functionality by inhibiting both VEGF and IL-6-mediated inflammation through its binding to JAK1 and other kinases relevant to retinal disease - Vorolanib provides multi-MOA functionality by inhibiting both VEGF and IL-6 activation of inflammation[49](index=49&type=chunk) - Vorolanib binds JAK1, inhibiting IL-6 activity in vitro, and targets multiple kinases of interest in retinal disease, including JAKs, TIE, PDGFR, FLT3, Kit, VEGFRs, and FGFR[50](index=50&type=chunk) [DURAVYU for DME: Clinical Data](index=18&type=section&id=DURAVYU%20in%20DME%3A%20Single%20DURAVYU%202.7mg%20Treatment%20Demonstrated%20Meaningful%20Vision%20and%20Anatomical%20Improvement%20as%20Early%20as%20Week%204) [Phase 2 VERONA Efficacy](index=18&type=section&id=DURAVYU%20in%20DME%3A%20Single%20DURAVYU%202.7mg%20Treatment%20Demonstrated%20Meaningful%20Vision%20and%20Anatomical%20Improvement%20as%20Early%20as%20Week%204_Efficacy) In the Phase 2 VERONA trial, a single **2.7mg** DURAVYU treatment demonstrated meaningful and rapid improvements in vision (BCVA) and anatomical control (CST) as early as **Week 4**, with sustained effects up to **Week 24**, outperforming aflibercept in both metrics VERONA Trial: BCVA Change from Baseline (Week 24) | Treatment | Mean Change in ETDRS Letters | | :--- | :--- | | DURAVYU 2.7mg (n=10, ex-outlier) | +10.1 | | Aflibercept 2mg (n=6) | +7.1 | VERONA Trial: CST Change from Baseline (Week 24) | Treatment | Mean Change in Microns | | :--- | :--- | | DURAVYU 2.7mg (n=10, ex-outlier) | -75.9 | | Aflibercept 2mg (n=6) | -43.7 | [Comparative Efficacy & Treatment Burden](index=19&type=section&id=DURAVYU%20in%20DME%3A%202.7%20mg%20in%20Supplement-Free%20Eyes%20Achieved%20Similar%20BCVA%20Contrasted%20to%20Anti-VEGF%20%2B%20Anti-IL-6%20Dosed%20Monthly) A single **2.7mg** DURAVYU dose, combined with a single aflibercept dose, achieved comparable BCVA improvements to monthly anti-VEGF + anti-IL-6 combination therapy (**12 injections vs. 2 injections**) in supplement-free eyes, significantly reducing treatment burden - In supplement-free eyes, a single DURAVYU **2.7mg** dose (with a single aflibercept dose) achieved comparable BCVA to monthly anti-IL6 (vamikibart) + ranibizumab, significantly reducing the number of injections (**2 vs. 12**)[56](index=56&type=chunk) [Macular Leakage Reduction](index=20&type=section&id=DURAVYU%20in%20DME%3A%20Dose-Dependent%20Reduction%20in%20Macular%20Leakage%20Area%20with%20a%20Single%20DURAVYU%20Injection) A single DURAVYU injection demonstrated a marked and dose-dependent reduction in macular leakage area at **Week 24**, a key biomarker of vascular stability in DME, with the **2.7mg** dose showing the most significant improvement Vascular Leakage Area Change from Baseline to Week 24 | Treatment | Change (mm²) | | :--- | :--- | | DURAVYU 2.7 mg (n=10) | -3.14 | | DURAVYU 1.3 mg (n=11) | -2.02 | | Aflibercept 2.0 mg (n=6) | -0.66 | - Marked reduction in leakage area at **Week 24** after a single DURAVYU **2.7 mg** dose and no supplementation, indicating improved vascular stability[58](index=58&type=chunk) [Patient Case Study](index=21&type=section&id=DURAVYU%20in%20DME%3A%20Continued%20Drying%20at%20Week%2024%20with%20Improved%20BCVA%20After%20a%20Single%20DURAVYU%202.7%20mg%20Dose%20%3A%20No%20Supplementation) A patient case study demonstrated continued fluid drying and improved BCVA (**+8 letters**) at **Week 24** after a single DURAVYU **2.7mg** dose with no supplementation, showing a more favorable response compared to prior VABYSMO treatment - A patient case showed fluid drying and vision improvement (**+8 letters BCVA**) at **Week 24** after a single DURAVYU **2.7mg** dose, with no supplementation, responding more favorably than to VABYSMO[60](index=60&type=chunk)[61](index=61&type=chunk) [DURAVYU for DME: Phase 3 Plans](index=22&type=section&id=DURAVYU%20for%20DME_Phase3) [Phase 3 Clinical Program Design](index=23&type=section&id=DURAVYU%20in%20DME%3A%20Phase%203%20Clinical%20Program%20is%20Designed%20to%20Drive%20Global%20Regulatory%20and%20Commercial%20Success) EyePoint's Phase 3 clinical program for DME, consisting of two global, randomized, double-masked, non-inferiority trials ('COMO' and 'CAPRI'), is designed to demonstrate DURAVYU's efficacy and reduced treatment burden compared to on-label aflibercept, with First Patient In (FPI) anticipated in **Q1 2026** - The Phase 3 DME program includes **two pivotal**, non-inferiority trials ('COMO' and 'CAPRI'), each with **~240 patients**, comparing **2.7mg** DURAVYU every **six months** to on-label aflibercept[65](index=65&type=chunk) - Primary endpoint is the difference in mean change in BCVA from Day 1 to **Week 52 and 56** (blended) versus aflibercept control[65](index=65&type=chunk) - First Patient In (FPI) for the DME Phase 3 trials is anticipated in **Q1 2026**, leveraging existing clinical trial infrastructure from the wet AMD program[66](index=66&type=chunk) [DME Program Summary](index=26&type=section&id=DURAVYU%E2%84%A2%3A%20The%20Only%20TKI%20in%20Development%20for%20DME) DURAVYU is positioned as the only TKI in development for DME, offering dual anti-VEGF and anti-IL-6 inhibition, with positive Phase 2 VERONA results supporting its multi-MOA approach, and Phase 3 pivotal trials expected to commence in **Q1 2026** following FDA alignment - DURAVYU is the **only TKI** in development for DME, providing **dual anti-VEGF and anti-IL-6 inhibition** to alleviate vascular leakage and inflammation[70](index=70&type=chunk) - Positive Phase 2 VERONA trial results showed early and sustained improvements in vision and anatomy, underscoring the potential clinical utility of vorolanib's multi-MOA[70](index=70&type=chunk) - Following a positive End-of-Phase 2 meeting with the FDA, initiation of Phase 3 pivotal trials in DME is expected in **Q1 2026**[70](index=70&type=chunk)