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)

Core Insights - EyePoint Pharmaceuticals is advancing its lead product candidate, DURAVYU, through pivotal Phase 3 clinical trials for wet age-related macular degeneration (AMD) and diabetic macular edema (DME), with data readouts expected in mid-2026 [1][2][5] Clinical Development - DURAVYU is currently in Phase 3 trials for both wet AMD and DME, with the LUGANO trial fully enrolled and on track for data readout in mid-2026, followed closely by the LUCIA trial [1][5] - The company has initiated a pivotal Phase 3 DME program consisting of two identical non-inferiority trials, COMO and CAPRI, with first patient dosing anticipated in Q1 2026 [1][2][5] - DURAVYU is positioned as the only tyrosine kinase inhibitor (TKI) in development for DME, a market valued at approximately $3 billion [2][5] Financial Performance - For Q3 2025, total net revenue was reported at $1.0 million, a significant decrease from $10.5 million in Q3 2024 [7] - Net revenue from license and royalties for Q3 2025 totaled $0.4 million, down from $9.9 million in the same period last year, primarily due to the recognition of deferred revenue from a 2023 licensing agreement [8] - Operating expenses for Q3 2025 were $63.0 million, compared to $43.3 million in Q3 2024, driven by increased clinical trial costs related to DURAVYU [9] Funding and Cash Position - The company completed an oversubscribed equity financing, raising $172.5 million, which fully funds the DME pivotal program and extends the cash runway into Q4 2027 [4][6] - As of September 30, 2025, cash, cash equivalents, and marketable securities totaled $204 million, down from $371 million at the end of 2024 [10][11] Research and Development Highlights - Preclinical data indicates DURAVYU's potential as a multi-target treatment, inhibiting both VEGF-mediated vascular permeability and IL-6 mediated inflammation, which are key contributors to wet AMD and DME [4][5] - DURAVYU's Phase 2 VERONA trial data demonstrated early and sustained improvements in visual acuity, reinforcing its potential utility in treating DME [5][14]

Core Viewpoint - EyePoint Pharmaceuticals, Inc. is set to report its third quarter 2025 financial results and discuss recent corporate developments during a conference call on November 5, 2025 [1] Company Overview - EyePoint Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing innovative therapeutics for serious retinal diseases [3] - The company's lead product candidate, DURAVYU, is an investigational sustained delivery treatment for serious retinal diseases, 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 data expected in mid-2026, and the first patient dosing in trials for diabetic macular edema (DME) anticipated in Q1 2026 [3] Product Information - Vorolanib is exclusively licensed to EyePoint for the localized treatment of all ophthalmic diseases outside of specific regions in Asia [5] - DURAVYU has received conditional acceptance from the FDA as the proprietary name for EYP-1901 (vorolanib intravitreal insert) but is not yet authorized for sale in any country [6] Commitment to Community - The company aims to partner with the retina community to enhance patient lives while creating long-term value, having developed four approved drugs over three decades and treated tens of thousands of patients [4]

Core Insights - EyePoint Pharmaceuticals has initiated its pivotal Phase 3 program for Duravyu (vorolanib intravitreal insert) targeting diabetic macular edema (DME), with first patient dosing expected in Q1 2026 [1] - DME is a significant cause of vision loss in diabetes patients, resulting from fluid leakage into the macula [1] Phase 3 Clinical Program Overview - The FDA has approved a pathway for DME consisting of two identical non-inferiority trials named "COMO" and "CAPRI," with redosing of Duravyu every six months [2] - Each trial will enroll around 240 patients, including both previously treated and treatment-naïve individuals, who will be randomly assigned to either a Duravyu 2.7mg arm or a 2mg aflibercept control arm [2] Primary Endpoint - The primary endpoint of the trials is the change from baseline in best-corrected visual acuity (BCVA) at weeks 52 and 56, compared to the on-label 2mg aflibercept [3] Preclinical Data - New preclinical data indicates that vorolanib inhibits IL-6 mediated inflammation by blocking all Janus Kinase (JAK) receptors, in addition to its known effect on VEGF mediated vascular permeability [4] - IL-6 is a pro-inflammatory cytokine elevated in DME and wet AMD patients, contributing to vascular leakage and inflammation [5] Funding and Financials - EyePoint Pharmaceuticals has priced a public offering of 11 million shares at $12 each, along with pre-funded warrants for an additional 1.5 million shares at $11.999 per warrant, aiming for approximately $150 million in gross proceeds [6] - The proceeds will be utilized to advance the clinical development of Duravyu for wet AMD and DME, support earlier-stage pipeline initiatives, and for general corporate purposes [6] Stock Performance - As of the latest check, EyePoint Pharmaceuticals' stock is down 1.98% at $12.90 [7]

Core Viewpoint - EyePoint Pharmaceuticals, Inc. has announced a public offering of 11 million shares at $12.00 per share, aiming to raise approximately $150 million to support its clinical development and corporate initiatives [1][2]. Group 1: Offering Details - The offering includes 11,000,000 shares of common stock priced at $12.00 each and pre-funded warrants for 1,500,000 shares at $11.999 each, with total gross proceeds expected to be around $150 million before expenses [1]. - The closing of the offering is anticipated on or about October 16, 2025, pending customary closing conditions [1]. - Underwriters have a 30-day option to purchase an additional 1,875,000 shares at the public offering price [1]. Group 2: Use of Proceeds - Net proceeds from the offering will be utilized to advance the clinical development of DURAVYU™ for wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME), as well as to support earlier stage pipeline initiatives and general corporate purposes [2]. Group 3: Company Overview - EyePoint Pharmaceuticals is a clinical-stage biopharmaceutical company focused on innovative therapeutics for serious retinal diseases, with its lead product candidate, DURAVYU™, currently in Phase 3 trials for wet AMD and expected to initiate trials for DME in early 2026 [6][8]. - The company has a history of developing four approved drugs over three decades, treating tens of thousands of patients [7].

Core Viewpoint - EyePoint Pharmaceuticals, Inc. has initiated a public offering of $150 million in common stock to support its clinical development and corporate initiatives [1][3]. Group 1: Offering Details - The public offering consists of $150 million in shares, with an option for underwriters to purchase an additional $22.5 million within 30 days [1][2]. - J.P. Morgan, Jefferies, Citigroup, and Guggenheim Securities are the joint book running managers for the offering [2]. Group 2: Use of Proceeds - The net proceeds from the offering will be utilized to advance the clinical development of DURAVYU™ for wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME), as well as to support earlier stage pipeline initiatives and general corporate purposes [3]. Group 3: Company Overview - EyePoint Pharmaceuticals is a clinical-stage biopharmaceutical company focused on innovative therapeutics for serious retinal diseases, with its lead product candidate being DURAVYU™, which is currently in Phase 3 trials [7]. - DURAVYU™ combines vorolanib, a selective tyrosine kinase inhibitor, with next-generation bioerodible Durasert E™ technology [7]. - The company has a history of developing four approved drugs over three decades, treating tens of thousands of patients [8].

Core Insights - EyePoint Pharmaceuticals is advancing DURAVYU (vorolanib intravitreal insert) into Phase 3 trials for diabetic macular edema (DME), with first patient dosing expected in Q1 2026 [1][14] - New preclinical data indicates that vorolanib inhibits both VEGF-mediated vascular permeability and IL-6 mediated inflammation, which are significant factors in wet AMD and DME [1][4] - DURAVYU is positioned as a potential multi-mechanism treatment option, addressing both inflammation and vascular leakage, which are critical in managing DME [2][5] Company Overview - EyePoint Pharmaceuticals is a clinical-stage biopharmaceutical company focused on innovative therapeutics for serious retinal diseases [15] - The lead product candidate, DURAVYU, utilizes next-generation Durasert E technology for sustained drug delivery [10][15] - Vorolanib, the active ingredient in DURAVYU, is a selective tyrosine kinase inhibitor targeting both VEGF and IL-6 pathways [11][12] Clinical Development - The Phase 3 program for DME consists of two identical non-inferiority trials, enrolling approximately 240 patients each, comparing DURAVYU to aflibercept [6][12] - The primary endpoint of the trials is the change in best corrected visual acuity (BCVA) at weeks 52 and 56 [6] - Previous Phase 2 trials demonstrated significant treatment burden reduction, with approximately 88% fewer injections needed after six months [12] Market Need - There is a significant unmet need for effective treatments for DME, as up to two-thirds of patients remain active despite anti-VEGF therapies [5][8] - The multifactorial nature of DME necessitates treatment options that address both VEGF and inflammatory pathways [5][8] - DME is a leading cause of vision loss in diabetic patients, affecting approximately 28 million people globally [9] Future Outlook - The retinal community is optimistic about DURAVYU's potential to improve patient outcomes, particularly given its favorable safety profile and dosing intervals compared to existing therapies [8][14] - EyePoint plans to present preclinical data on JAK/IL-6 inhibition at the Eyecelerator meeting at AAO 2025 [8]

Summary of EyePoint Pharmaceuticals (EYPT) 2025 Conference Call Company Overview - EyePoint Pharmaceuticals focuses on sustained delivery of therapeutics to the eye using DuraCert delivery technology [3][4] - The company has progressed from initial Phase I trials to two global Phase III trials, each enrolling over 400 patients [3][4] Key Developments - EyePoint expects to be the first to read out both Phase III trials in 2026, file for NDA, and launch in 2027 [4][73] - Enrollment for the trials was completed in seven months, significantly faster than the average of twelve months for similar trials [5][6] - The Lugano trial had approximately 80% U.S. patients, while the overall trials will have about 90% U.S. patients, which is favorable for FDA approval [10] Trial Design and Expectations - The Phase III trials are designed to be identical, with no changes made since inception, ensuring consistency in protocol [12][23] - The trials aim for non-inferiority to aflibercept, with a focus on visual acuity as the primary endpoint [25][26] - Redosing every six months is included in the trial design, with a total of four doses over the course of the clinical trial [19][20] Safety and Efficacy - The safety profile remains strong, with no serious adverse events reported in over 190 patients during Phase II [43][44] - The next safety update is expected after the Data Safety Monitoring Committee meeting in November [45] Market Position and Competitive Landscape - The wet AMD market is valued at approximately $14 billion to $15 billion, with EyePoint's DuraVu positioned as a unique treatment option due to its different mechanism of action [58][60] - EyePoint emphasizes that DuraVu is not just another anti-VEGF therapy, but a TKI that blocks intracellular signaling of VEGF [30][60] - The company aims to capture a significant market share by offering a different treatment regimen that includes both DuraVu and existing anti-VEGF therapies [30][62] Regulatory and Commercial Strategy - EyePoint has received protocol approval from both U.S. and EU regulatory agencies, indicating a strong regulatory path [33] - The company plans to launch DuraVu independently in the U.S. while considering partnerships for international markets later [34][35] Financial Outlook - As of Q2, EyePoint reported $256 million in cash, with guidance indicating sufficient funds into 2027 [75][76] - The company has managed cash effectively, with spending aligned with rapid trial enrollment [76] Future Opportunities - EyePoint is also exploring the diabetic macular edema (DME) market, with plans for a smaller trial expected to start in 2026 [52][54] - The DME program is seen as a significant opportunity, with positive feedback from the retina community regarding the potential for improved patient compliance [50][51] Conclusion - EyePoint Pharmaceuticals is on track for significant milestones in the coming years, with a strong focus on execution, safety, and regulatory compliance as it prepares for the launch of DuraVu in the competitive wet AMD market [76]