EyePoint Pharmaceuticals(EYPT) - 2025 Q3 - Quarterly Results

Legal Disclaimers Summary of Disclaimers 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] Company Overview & Pipeline Company 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] - The company utilizes Durasert® delivery technology, which has a strong safety profile across multiple FDA-approved products[7] Financial Runway | Metric | Value | | :--- | :--- | | Cash & Equivalents (as of 9/30/25) | $200 million+ | | Runway | Into 2027 (beyond Phase 3 wet AMD data) | Pipeline Programs 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] Market Opportunity 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] 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] Durasert E™ Technology & DURAVYU Overview Durasert E™ Technology 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] - DURAVYU (vorolanib) offers a novel mechanism of action, inhibiting signaling from all VEGF isoforms at the receptor level[14] - DURAVYU achieves therapeutic levels within hours and provides consistent daily dosing with receptor inhibition for ≥6 months[14] DURAVYU Clinical Data Summary 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] DURAVYU for Wet AMD Phase 3 Pivotal Program 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][22] - 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] 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 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] - DURAVYU registration batches are underway to support future NDA filing[28] DURAVYU for DME: Market & Mechanism DME Market Opportunity & Unmet Needs 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] - The global branded market for DME is projected to reach $10 billion by 2030[34] - 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][37] DME Pathogenesis: VEGF & Inflammation 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][41] - 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][45][48] Vorolanib's Multi-MOA in DME 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] - 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] DURAVYU for DME: Clinical Data Phase 2 VERONA 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 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] Macular Leakage Reduction 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] Patient Case Study 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][61] DURAVYU for DME: Phase 3 Plans Phase 3 Clinical Program Design 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] - Primary endpoint is the difference in mean change in BCVA from Day 1 to Week 52 and 56 (blended) versus aflibercept control[65] - 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] DME Program Summary 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] - 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] - 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]