Duravyu (voroloanib intravitreal insert) / Betta Pharma, EyePoint Pharma - LARVOL DELTA

EyePoint Announces Positive Recommendation from Independent Data Safety Monitoring Committee for Pivotal Phase 3 Trials for DURAVYU in Wet Age-Related Macular Degeneration (GlobeNewswire) - "On track to report topline 56-week data for LUGANO in mid-2026 with LUCIA data to closely follow...As of the September 29, 2025 data cutoff for the DSMC review, all patients across the LUGANO and LUCIA trials reached the Week 8 visit during which patients in the DURAVYU arms received their initial DURAVYU dose, and approximately 25% of those patients received their second planned dose of DURAVYU at Week 32....The DSMC recommended that both the LUGANO and LUCIA trials continue as planned, with no modifications to the protocol."

DSMB • P3 data: top line • Wet Age-related Macular Degeneration

DURAVYU Phase 3 DME Clinical Program Overview (GlobeNewswire) - "DURAVYU now in Phase 3 for the two largest, multi-billion-dollar retinal disease markets, wet AMD and DME with first patient dosing in pivotal Phase 3 DME trials anticipated in Q1 2026....U.S. Food and Drug Administration (FDA) alignment on approval pathway in DME consisting of two identical non-inferiority trials ('COMO' and 'CAPRI'). The trials will include redosing of DURAVYU every six months; Each trial will enroll approximately 240 patients, including both previously treated and treatment naïve patients, who will be randomly assigned to either a DURAVYU 2.7mg arm or an on-label 2mg aflibercept control arm. Randomization occurs on Day 1; The primary endpoint is the change from baseline in best corrected visual acuity (BCVA) to weeks 52 and 56, blended, compared to on-label 2mg aflibercept."

New P3 trial • Diabetic Macular Edema • Wet Age-related Macular Degeneration

Data Supporting DURAVYU for the Treatment of DME (GlobeNewswire) - "New data demonstrates that DURAVYU has the potential to be a multi-MOA treatment, inhibiting both VEGF via inhibition of all VEGFRs and IL-6 signaling via JAK receptor blockage. IL-6 is a pro-inflammatory cytokine that has been observed at significantly higher levels in patients with DME and wet AMD compared to healthy individuals. IL-6 signaling occurs via activation of the JAK kinases, particularly JAK-1, leading to vascular leakage and inflammation that together compound damage to the blood-retinal barrier in DME....The Company will be presenting the preclinical data on JAK/IL-6 inhibition at the Eyecelerator meeting at AAO 2025."

Preclinical • Diabetic Macular Edema • Wet Age-related Macular Degeneration

EYP-1901-302: A 2-year Study of EYP-1901 in Subjects With Wet Age Related Macular Degeneration (wAMD) (LUCIA) Primary Efficacy Will be Determined at Week 56 (clinicaltrials.gov) - P3 | N=400 | Active, not recruiting | Sponsor: EyePoint Pharmaceuticals, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Treatment of Retinal/Choroidal Vascular Diseases by Sustained Delivery of VEGF Receptor Tyrosine Kinase Inhibitors. (PubMed, Am J Ophthalmol) - "Sustained delivery of VEGF receptor TKIs represents a promising therapeutic paradigm for retinal and choroidal vascular diseases, potentially reducing treatment burden while maintaining efficacy. Continued evaluation through larger, controlled clinical trials is essential to validate these early findings and define the role of these agents in clinical practice."

Clinical • Journal • Age-related Macular Degeneration • Cardiovascular • Diabetic Macular Edema • Diabetic Retinopathy • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

A 2-year Study of EYP-1901 in Subjects With Wet Age Related Macular Degeneration (wAMD) (LUGANO) Primary Efficacy Will be Determined at Week 56 (clinicaltrials.gov) - P3 | N=400 | Active, not recruiting | Sponsor: EyePoint Pharmaceuticals, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

EyePoint Completes Enrollment in Pivotal Phase 3 LUGANO Trial of DURAVYU for Treatment of Wet Age-Related Macular Degeneration (GlobeNewswire) - "EyePoint Pharmaceuticals, Inc...today announced it has enrolled and randomized over 400 patients in the Phase 3 LUGANO pivotal trial of DURAVYU for the treatment of wet age-related macular degeneration (wet AMD) exceeding its enrollment target....With both pivotal trials continuing to exceed our timelines, we now expect topline data for the LUGANO trial in mid-2026 with LUCIA to follow in the second half of 2026....With enrollment in the LUGANO trial completed, our focus is on completing enrollment for the LUCIA trial in the third quarter of 2025."

P3 data: top line • Trial status • Wet Age-related Macular Degeneration

Beyond the injection: delivery systems reshaping retinal disease management. (PubMed, Expert Opin Pharmacother) - "Specific innovations discussed include the ranibizumab port delivery system, EYP-1901 (Duravyu, vorolanib implant), KSI-301 (tarcocimab tedromer), KSI-501, OTX-TKI (Axpaxli, axitinib implant), 4D-150, revakinagene taroretcel-lwey (Encelto, NT-501, encapsulated cell therapy), Xipere (triamcinolone acetonide injectable suspension), AU-011 (belzupacap sarotalocan targeted delivery), ABBV-RGX-314, elamipretide, and OCS-01 (high concentration dexamethasone)...Challenges include overcoming the blood-retinal barrier, surgical complications with implantable devices, and ensuring patient adherence. Advances in smart delivery systems, drug formulations, and predictive models, alongside interdisciplinary collaboration, will be crucial in achieving personalized, effective, and sustainable retinal therapies."

Journal • Review • Age-related Macular Degeneration • Diabetic Macular Edema • Diabetic Retinopathy • Gene Therapies • Macular Degeneration • Ophthalmology • Retinal Disorders

EyePoint Reports First Quarter 2025 Financial Results and Highlights Recent Corporate Developments (GlobeNewswire) - "For the first quarter ended March 31, 2025, total net revenue was $24.5 million compared to $11.7 million for the quarter ended March 31, 2024. Net product revenue for the first quarter was $0.7 million, consistent with the first quarter ended March 31, 2024....This increase was primarily driven by costs associated with ongoing LUGANO and LUCIA Phase 3 trials for DURAVYU in wet AMD as enrollment is tracking ahead of expectations. Net non-operating income totaled $3.6 million and net loss was $45.2 million, or ($0.65) per share, compared to a net loss of $29.3 million, or ($0.55) per share, for the corresponding period in 2024."

Commercial • Age-related Macular Degeneration

PAVIA phase 2 trial of EYP-1901 in nonproliferative diabetic retinopathy: 12-month results (ARVO 2025) - P2 | "EYP-1901 includes a bioerodible intravitreal insert for sustained-delivery of vorolanib, a pan-vascular endothelial growth factor receptor inhibitor, for ≥6 months. Layman Abstract (optional): Provide a 50-200 word description of your work that non-scientists can understand. Describe the big picture and the implications of your findings, not the study itself and the associated details."

P2 data • Diabetic Macular Edema • Diabetic Retinopathy • Ocular Infections • Ocular Inflammation • Ophthalmology • Retinal Disorders

12-month interim phase results from a good laboratory practice (GLP) pivotal repeat-dose toxicity study of EYP-1901 (vorolanib intravitreal insert) in Dutch-Belted rabbits (ARVO 2025) - "EYP-1901 has the potential to reduce the treatment burden in patients with wAMD if shown to be safe and effective.This study used Dutch-Belted rabbits to investigate the long-term safety of EYP-1901 with repeat dosing at a range of drug levels, to support use in phase 3 clinical trials. No adverse findings were observed, supportive of safety with repeat dosing.Clinical safety and efficacy of EYP-1901 will be assessed in the phase 3 trials LUGANO and LUCIA, enrolling patients globally with wAMD."

Preclinical • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Assessment of treatment burden in wet age-related macular degeneration treated with EYP-1901 (vorolanib intravitreal insert) versus aflibercept: DAVIO 2 trial results (ARVO 2025) - P2 | "All patients in DAVIO 2 had been treated for wet AMD before the trial.In DAVIO 2, 63% of EYP-1901-treated eyes did not need any additional aflibercept treatment to control their disease up to 6 months after receiving EYP-1901, with half of patients receiving their first supplemental treatment ~9-10 months after EYP-1901. Overall, this was an ~80% reduction in treatment burden versus how often these patients were treated before the trial, and 70% reduction versus patients receiving standard-of-care treatment during the trial."

Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

LUGANO and LUCIA trial design: Pivotal phase 3 studies of EYP-1901 vs aflibercept in wet age-related macular degeneration (ARVO 2025) - P2, P3 | "EYP-1901 provides sustained-release of the tyrosine kinase inhibitor, vorolanib, that acts as a selective pan-vascular endothelial growth factor receptor inhibitor...The phase 3 trials LUGANO and LUCIA will compare EYP-1901 given as an injection into the eye every 6 months versus the standard of care, aflibercept 2.0 mg (Eylea) given as an injection into the eye every 8 weeks...At each monthly visit, patients will be assessed to determine if supplemental treatment with aflibercept 2.0mg is needed to control their disease.The main objective of the study is to assess whether patients' vision after one year of EYP-1901 treatment is similar to vision of patients treated with aflibercept. Other objectives include determining if patients who received EYP-1901 required fewer injections and how safe the treatment is."

P3 data • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

EyePoint Reports Fourth Quarter and Full-Year 2024 Financial Results and Highlights Recent Corporate Developments (GlobeNewswire) - "Global Phase 3 LUGANO and LUCIA pivotal trials of DURAVYU in wet AMD well underway with both trials exceeding expectations...We remain on-track to complete enrollment of both trials in the second half of 2025 with topline data anticipated in 2026."

Enrollment status • P3 data: top line • Wet Age-related Macular Degeneration

EyePoint Reports Fourth Quarter and Full-Year 2024 Financial Results and Highlights Recent Corporate Developments (GlobeNewswire) - P2 | N=27 | VERONA (NCT06099184) | Sponsor: EyePoint Pharmaceuticals, Inc. | "In March 2025, we presented positive 24-week supplement-free patient subgroup analyses from the Phase 2 VERONA clinical trial in DME demonstrating that DURAVYU 2.7mg significantly improved vision and fluid versus baseline compared to the aflibercept control group, including: BCVA improvement of +10.3 letters versus +3.0 letters for aflibercept control; CST improvement of 117.4 microns versus 43.7 microns for aflibercept control; 43% had an absence of DME compared to zero for the aflibercept control arm."

P2 data • Diabetic Macular Edema

VERONA: Study of EYP-1901 in Patients With Diabetic Macular Edema (DME) (clinicaltrials.gov) - P2 | N=27 | Completed | Sponsor: EyePoint Pharmaceuticals, Inc. | Recruiting ➔ Completed

Trial completion • Diabetic Macular Edema • Ophthalmology

EyePoint to Present Corporate Update at TD Cowen 45th Annual Health Care Conference (GlobeNewswire) - "EyePoint Pharmaceuticals, Inc...announced that Jay S. Duker, M.D., EyePoint’s President and CEO, will present an update on enrollment for its ongoing Phase 3 pivotal program of DURAVYU in wet age-related macular degeneration (wet AMD) and additional subgroup analyses for the Phase 2 VERONA trial for DURAVYU in diabetic macular edema (DME) at the TD Cowen 45th Annual Health Care Conference."

Enrollment status • P2 data • Age-related Macular Degeneration • Diabetic Macular Edema

EyePoint Announces Positive Six-Month Results for the Phase 2 VERONA Clinical Trial of DURAVYU for Diabetic Macular Edema Meeting Primary and Secondary Endpoints (GlobeNewswire) - P2 | N=25 | VERONA (NCT06099184) | Sponsor: EyePoint Pharmaceuticals, Inc. | "Both DURAVYU doses (1.34 mg and 2.7mg) met the primary endpoint of extended time to first supplemental injection versus aflibercept control. DURAVYU 2.7mg demonstrated an early and sustained improvement in both best corrected visual acuity (BCVA) and central subfield thickness (CST) as measured by optical coherence tomography (OCT). BCVA improved +7.1 letters compared to baseline. CST improved 75.9 microns compared to baseline representing 74% more drying in DURAVYU eyes versus aflibercept control. Visual and anatomical gains were observed at Week 4 demonstrating the immediate bioavailability of DURAVYU. 73% of eyes in the DURAVYU 2.7mg arm were supplement-free versus 50% in the aflibercept control arm up to week 24 underscoring that the positive efficacy results were driven by treatment with DURAVYU and not supplemental injections."

P2 data • Diabetic Macular Edema

EYP-1901-302: A 2-year Study of EYP-1901 in Subjects with Wet Age Related Macular Degeneration (wAMD) (LUCIA) Primary Efficacy Will Be Determined At Week 52 (clinicaltrials.gov) - P3 | N=400 | Recruiting | Sponsor: EyePoint Pharmaceuticals, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

A 2-year Study of EYP-1901 in Subjects with Wet Age Related Macular Degeneration (wAMD) (LUCIA) Primary Efficacy Will Be Determined At Week 52 (clinicaltrials.gov) - P3 | N=400 | Not yet recruiting | Sponsor: EyePoint Pharmaceuticals, Inc.

New P3 trial • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

A 2-year Study of EYP-1901 in Subjects With Wet Age Related Macular Degeneration (wAMD) (LUGANO). Primary Efficacy Will be Determined at Week 52. (clinicaltrials.gov) - P3 | N=400 | Recruiting | Sponsor: EyePoint Pharmaceuticals, Inc.

New P3 trial • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Exploring new horizons in neovascular age-related macular degeneration: novel mechanisms of action and future therapeutic avenues. (PubMed, Eye (Lond)) - "Gene therapies, including RGX-314 and Ixo-vec, express an anti-VEGF protein, and 4D-150, expresses an anti-VEGF protein and a VEGF-C inhibitory miRNA. Anti-VEGF associated therapeutics include OPT-302, targeting VEGF-C and VEGF-D, BI 836880, which inhibits VEGF-A and Ang-2 activity, and Tarcocimab tedromer, inhibiting all VEGF-A isoforms. Agents with novel mechanisms of action include UBX1325, which inhibits an anti-apoptotic protein, Restoret (EYE103), a Wnt agonist, and the tyrosine kinase inhibitors, EYP-1901, OTX-TKI, CLS-AX, and KHK4951."

Journal • Review • Age-related Macular Degeneration • Gene Therapies • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration • VEGFC • VEGFD

Role of EYP-1901 in neovascular age-related macular degeneration and diabetic eye diseases: review of Phase I/II trials. (PubMed, Ther Deliv) - "EYP-1901 is integrated with the Durasert drug delivery system to administer a sustained release of vorolanib directly to the posterior segment of the eye. This delivery system ensures a consistent therapeutic effect over an extended period and significantly reduces the frequency of clinical interventions required, offering a more convenient treatment regimen while maintaining patient safety."

Journal • P1/2 data • Review • Age-related Macular Degeneration • Diabetic Macular Edema • Diabetic Retinopathy • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

EYP-1901 for the Treatment of Neovascular AMD: Phase 2 DAVIO2 End-of-Study 12-Month Results (AAO 2024) - No abstract available

P2 data • Ophthalmology • Wet Age-related Macular Degeneration

VERONA: Study of EYP-1901 in Patients With Diabetic Macular Edema (DME) (clinicaltrials.gov) - P2 | N=25 | Recruiting | Sponsor: EyePoint Pharmaceuticals, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Diabetic Macular Edema • Ophthalmology