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

CAPRI: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME (clinicaltrials.gov) - P3 | N=240 | Active, not recruiting | Sponsor: EyePoint Pharmaceuticals, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Diabetic Macular Edema • Ophthalmology

COMO: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME (clinicaltrials.gov) - P3 | N=240 | Active, not recruiting | Sponsor: EyePoint Pharmaceuticals, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Diabetic Macular Edema • Ophthalmology

EyePoint Announces Participation at Upcoming Investor Conferences and Scientific Meeting (GlobeNewswire) - "EyePoint will be participating at The Retina Society 59th Annual Scientific Meeting from September 23-26, 2026, in Los Angeles, CA."

Clinical data • P3 data • Wet Age-related Macular Degeneration

The Company anticipates potentially filing an NDA for DURAVYU for the potential treatment of wet AMD in the first half of 2027. (The Manila Times)

FDA filing • Wet Age-related Macular Degeneration

EyePoint Announces Topline Data from LUGANO, the First of Two Pivotal Phase 3 Clinical Trials for DURAVYU 2.7mg in Wet AMD (The Manila Times) - "DURAVYU was non-inferior to on-label aflibercept (nominal p-value = 0.0096) in an ad hoc analysis excluding a 4% asymmetric cohort (9 of 211 patients) who experienced vision loss (≥ 15 letters) unrelated to wet AMD....42% reduction in treatment burden, achieving superiority versus on-label aflibercept (nominal p-value...Supplement-Free Rates: 76% of DURAVYU patients were supplement-free up to Week 32; 94 % of DURAVYU patients received zero or one supplement up to Week 32...Strong anatomic control demonstrated DURAVYU’s potency with a mean difference of 4 microns versus on-label aflibercept control in central subfield thickness (CST) at Week 56...EyePoint plans to present additional details on the LUGANO dataset, including subgroup-analyses, at major retina conferences in the coming months, beginning at the Retina Society 59th Annual Scientific Meeting from September 23-26, 2026."

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

Wet Age-Related Macular Degeneration (Wet AMD) (GlobeNewswire) - "Pivotal Phase 3 wet AMD clinical trials are on track, with topline data readout for LUGANO expected in August 2026. LUCIA topline data results are expected in the fourth quarter of 2026....The two identical non-inferiority trials versus on-label aflibercept enrolled over 900 patients, include every six-month re-dosing of DURAVYU, were designed in alignment with the FDA, and follow a clear and recognized regulatory approval pathway."

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

Accepted to deliver multiple presentations at the Retina Society Annual Meeting in September… (GlobeNewswire) - "....underscoring the multi-modal activity and broad treatment potential of DURAVYU and enthusiasm from the retinal community for new treatment options in multiple serious retinal diseases. This will be the first conference where LUGANO data will be presented to the retinal community."

P3 data • Wet Age-related Macular Degeneration

EyePoint…announced it has completed enrollment in COMO and CAPRI, the two global Phase 3 clinical trials of DURAVYU (vorolanib intravitreal insert) for the treatment of diabetic macular edema (DME) (GlobeNewswire) - "Over 480 patients have been enrolled across both trials, with full enrollment occurring ahead of schedule, in only five months. Topline data for both DME trials are anticipated in the fourth quarter of 2027."

Enrollment closed • P3 data: top line • Diabetic Macular Edema

ASRS 2026: Vorolanib intravitreal insert delays supplemental injections in DME (Ophthalmology Times) - "VERONA randomized 27 patients with previously treated DME to a single injection of vorolanib insert 2.7 mg (n=11), 1.3 mg (n=10), or sham (n=6) following aflibercept 2.0 mg, with monthly assessment for supplemental anti-VEGF treatment per prespecified BCVA and OCT criteria. The trial met its primary end point, with both doses extending time to first supplemental injection versus aflibercept. Through week 24, 73% of eyes in the 2.7-mg arm (8/11) remained supplement-free, compared with 60% (6/10) in the 1.3-mg arm and 50% (3/6) with aflibercept.....Mean BCVA change from baseline was +7.1, +6.9, and +7.3 letters, respectively, and mean central subfield thickness change was −75.9 µm, −71.1 µm, and −43.7 µm. Greater reductions in mean macular leakage area (−3.1 and −2.0 vs −0.7 mm²)..."

P2 data • Diabetic Macular Edema

ASRS 2026: DAVIO 2 post hoc analysis shows stable vision and anatomy with EYP-1901 in patients meeting phase 3 criteria (Ophthalmology Times) - "BCVA remained stable through month 8—6 months after EYP-1901 administration—in both the full population and the phase 3 subgroup. In the subgroup, the month 7/8 blended least-squares mean BCVA change from baseline measured +1.5 letters with EYP-1901 2 mg, +1.6 letters with EYP-1901 3 mg, and +2.6 letters with aflibercept. Mean central subfield thickness changes in the subgroup measured +18.0 µm, +8.9 µm, and +0.8 µm, respectively. Applying the phase 3 supplemental treatment criteria reduced the proportion of patients meeting criteria compared with the phase 2 criteria—for example, 13.5% vs 36.5% with EYP-1901 3 mg."

Retrospective data • Wet Age-related Macular Degeneration

R&D Highlights and Updates (The Manila Times) - "Phase 3 wet AMD trials on track for data readouts beginning mid-year with LUGANO data and LUCIA data to shortly follow...Pivotal Phase 3 COMO and CAPRI trials are underway, with over one-third of patients enrolled and activation of ex-US sites now initiated; Full enrollment is expected in the third quarter of 2026, with topline data anticipated in the fourth quarter of 2027; The identical non-inferiority trials versus an on-label aflibercept control are expected to enroll approximately 480 patients, include every six-month re-dosing, and follow a clear and recognized regulatory approval pathway."

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

Unveiling the Potential of Drug Delivery Systems for Tyrosine Kinase Inhibitors in the Treatment of Neovascular Eye Diseases. (PubMed, Crit Rev Ther Drug Carrier Syst) - "Numerous TKI formulations currently under investigation (AXPAXLI, DURAVYU, CLS-AX and D-4517.2) hold the potential to improve therapeutic outcomes and enhance patient adherence, transforming the treatment landscape of NEDs. Advanced TKI delivery platforms, integrated with artificial intelligence-driven tools and minimally invasive technologies may enable more effective and personalized treatment options in the field of eye care."

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

EyePoint…announced that the independent Data Safety Monitoring Committee (DSMC) completed its third scheduled review of the Company’s pivotal Phase 3 program evaluating DURAVYU for wet age-related macular degeneration (wet AMD) and recommended that both the LUGANO and LUCIA trials continue as planned with no protocol modifications (GlobeNewswire) - "As of May 2, 2026, all active patients in the treatment arm have reached the Week 32 visit, during which patients received their second DURAVYU dose. Over 35% of those patients have also received their third planned dose at Week 56. Interim masked safety data from the Phase 3 trials show a continued favorable safety profile for DURAVYU, consistent with the safety observed in over 190 patients across four completed clinical trials....LUGANO topline data on track for mid-2026, with LUCIA readout to follow shortly after."

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

EYP-1901 in DME: Phase 2 VERONA trial reports extended time to retreatment (Ophthalmology Times) - "The primary end point was met. At week 24, 73% of eyes in the EYP-1901 2.7 mg arm required no supplemental anti-VEGF injection, compared with 60% in the 1.3 mg arm and 50% in the aflibercept control arm. Mean BCVA change from baseline at week 24 was +7.1, +6.9, and +7.3 ETDRS letters in the 2.7 mg, 1.3 mg, and aflibercept arms, respectively. Mean central subfield thickness (CST) reduction was −75.9 μm, −71.1 μm, and −43.7 μm, respectively. Greater reductions in macular leakage area and total macular volume were observed with both EYP-1901 doses compared with aflibercept."

P2 data • Diabetic Macular Edema

DAVIO 2 Phase 2 Trial: Vision Outcomes with Bioerodible EYP-1901 (vorolanib intravitreal insert) Versus Aflibercept in Wet Age-Related Macular Degeneration (wAMD) (ARVO 2026) - P2, P3 | "Patients' vision in the treated eye stayed above a level considered important for daily activities, such as driving, for most days in the 6 months following treatment with a single EYP-1901 dose, similar to treatment with aflibercept every 8 weeks. EYP-1901 with dosing every 6 months is being studied in larger global phase 3 clinical studies LUGANO and LUCIA."

P2 data • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration • IL6

DAVIO 2 phase 2 trial of bioerodible EYP-1901 (vorolanib intravitreal insert) for wet age-related macular degeneration: Results in subgroup that met LUGANO/LUCIA phase 3 inclusion criteria (ARVO 2026) - P2, P3 | "When data from DAVIO 2 was evaluated in the group of patients that were similar to those enrolled in the phase 3 studies, results were similar to the full trial population. Data from LUGANO are expected in mid-2026 with LUCIA soon after."

P2 data • P3 data • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration • IL6 • JAK1

Development of EYP-1901, a bioerodible intravitreal (IVT) insert for sustained release of the tyrosine kinase inhibitor (TKI) vorolanib for retinal exudative disease (ARVO 2026) - P2, P3 | "EYP-1901 has been optimized to increase the amount of drug in each insert while maintaining insert integrity and providing similar drug release. EYP-1901 has completed phase 2 trials in wAMD and DME, and phase 3 trials have either started or will be starting soon."

Age-related Macular Degeneration • Diabetic Macular Edema • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration • IL6 • JAK1

Vorolanib inhibition of IL-6 signaling: A novel multi-mechanism of action for EYP-1901 in retinal exudative diseases (ARVO 2026) - "Diseases such as wAMD and DME are multifactorial – involving the excessive formation of blood vessels in the eye in addition to inflammatory processes. Ongoing work shows that the drug vorolanib works in a unique way to address both of these aspects of retinal disease simultaneously."

Age-related Macular Degeneration • Diabetic Macular Edema • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration • IL6 • IL6R • JAK1

VERONA phase 2 clinical trial of bioerodible EYP-1901 (vorolanib intravitreal insert) versus aflibercept for diabetic macular edema (DME): Visual, anatomic, and angiographic outcomes (ARVO 2026) - P2 | "EYP-1901 was well-tolerated. EYP-1901 high dose will be further evaluated for DME in phase 3 trials COMO and CAPRI."

Clinical • P2 data • Diabetic Macular Edema • Ophthalmology • IL6 • JAK1

COMO and CAPRI trial design: Pivotal phase 3 non-inferiority studies of EYP-1901 vs on-label aflibercept in diabetic macular edema (ARVO 2026) - P2 | "EYP-1901 (vorolanib intravitreal insert) provides sustained release of vorolanib, a tyrosine kinase inhibitor with a novel multi-mechanism of action (MoA) providing pan-VEGF receptor inhibition in addition to blocking pro-inflammatory IL-6 signaling. EYP-1901 will be re-dosed every 6 months and compared to standard-of-care aflibercept injections every 8 weeks. The trials will aim to demonstrate similar vision outcomes with EYP-1901, but with fewer injections."

Head-to-Head • P3 data • Diabetic Macular Edema • Ophthalmology • IL6

CAPRI: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME (clinicaltrials.gov) - P3 | N=240 | Recruiting | Sponsor: EyePoint Pharmaceuticals, Inc.

Trial initiation date • Diabetic Macular Edema • Ophthalmology

Presented new preclinical data at the Association for Research in Vision and Ophthalmology (ARVO) 2026 Annual Meeting that further demonstrates inhibition of pro-inflammatory IL-6 signaling by vorolanib, the active drug in DURAVYU. (The Manila Times) - "Vorolanib was identified as a potent inhibitor of JAK1, a critical transducer of IL-6 signaling, through extensive in vitro and in vivo studies; These data further highlight DURAVYU's multi-mechanism of action and its potential to bring a synergistic anti-inflammatory effect to the established VEGFR and PDGF inhibition for treatment of wet AMD and DME."

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

EYP-1901-303: COMO: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME (clinicaltrialsregister.eu) - P2/3 | N=37 | Not yet recruiting | Sponsor: Eyepoint Pharmaceuticals Inc.

New P2/3 trial • Diabetic Macular Edema • Ophthalmology

EYP-1901-304: CAPRI: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME (clinicaltrialsregister.eu) - P2/3 | N=50 | Not yet recruiting | Sponsor: Eyepoint Pharmaceuticals Inc.

New P2/3 trial • Diabetic Macular Edema • Ophthalmology

COMO: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME (clinicaltrials.gov) - P3 | N=240 | Recruiting | Sponsor: EyePoint Pharmaceuticals, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Diabetic Macular Edema • Ophthalmology