Eyepoint Pharmaceuticals' Drug in the FDA Approval Process
This section highlights FDA-related milestones and regulatory updates for drugs developed by Eyepoint Pharmaceuticals (EYPT).
Over the past two years, Eyepoint Pharmaceuticals has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
DURAVYU. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
DURAVYU FDA Regulatory Timeline and Events
DURAVYU is a drug developed by Eyepoint Pharmaceuticals for the following indication: In patients with non-proliferative diabetic retinopathy (NPDR).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- DURAVYU
- Announced Date:
- May 14, 2026
- Indication:
- In patients with non-proliferative diabetic retinopathy (NPDR).
Announcement
EyePoint, Inc. 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.
AI Summary
EyePoint, Inc. said the independent Data Safety Monitoring Committee finished its third scheduled review of the Phase 3 DURAVYU program for wet age-related macular degeneration and recommended that both the LUGANO and LUCIA trials continue as planned, with no changes to the study design. The company said the masked data still show a favorable safety profile, matching results from four earlier clinical trials. It also noted that all active patients in the treatment group have reached their second dosing visit, and more than 35% have received a third dose.
EyePoint said LUGANO topline data are still expected in mid-2026, with LUCIA results to follow soon after. DURAVYU remains an investigational treatment and has not been approved. The company said earlier studies showed stable vision and eye anatomy control, with no drug-related safety concerns seen in more than 190 patients.
Read Announcement- Drug:
- DURAVYU
- Announced Date:
- March 2, 2026
- Indication:
- In patients with non-proliferative diabetic retinopathy (NPDR).
Announcement
EyePoint, Inc. announced the first patient dosed in both Phase 3 COMO and CAPRI global clinical trials of DURAVYU™ (vorolanib intravitreal insert) for the treatment of diabetic macular edema (DME).
AI Summary
EyePoint, Inc. announced the first patient has been dosed in both Phase 3 COMO and CAPRI global clinical trials of DURAVYU™ (vorolanib intravitreal insert) for the treatment of diabetic macular edema (DME). The company is running active Phase 3 programs for DURAVYU in wet age-related macular degeneration (wet AMD) and DME, two of the largest multi‑billion‑dollar retinal disease markets. These global studies aim to confirm the treatment’s benefit for patients with vision-threatening retinal disease.
Topline data for DURAVYU in DME is anticipated in the second half of 2027. Earlier Phase 1 and 2 trials showed safety and efficacy signals, with single-dose treatment demonstrating stability in vision and anatomical control. Across four completed trials involving over 190 patients, no safety signals were observed. EyePoint states it remains focused on working with the retina community to advance this investigational treatment.
Read Announcement- Drug:
- DURAVYU
- Announced Date:
- November 19, 2025
- Indication:
- In patients with non-proliferative diabetic retinopathy (NPDR).
Announcement
EyePoint Pharmaceuticals, Inc. announced that the independent Data Safety Monitoring Committee (DSMC) completed its second scheduled review of the Company's ongoing pivotal Phase 3 program evaluating DURAVYU for the treatment of wet age-related macular degeneration (wet AMD).
AI Summary
EyePoint Pharmaceuticals said an independent Data Safety Monitoring Committee (DSMC) completed its second scheduled review of the pivotal Phase 3 program testing DURAVYU for wet age-related macular degeneration (wet AMD). As of the Sept. 29, 2025 data cutoff, all patients in the LUGANO and LUCIA trials had reached the Week 8 visit, when DURAVYU arms received their initial dose, and about 25% had received the planned second dose at Week 32. The DSMC recommended both trials continue as planned with no protocol changes. Masked safety data showed no safety signals and were consistent with earlier clinical trials.
LUGANO and LUCIA are randomized, double‑masked, aflibercept‑controlled, non‑inferiority Phase 3 trials with enrollment complete (over 900 patients). Patients were randomized 1:1 to DURAVYU 2.7 mg every six months or on‑label aflibercept. EyePoint remains on track to report topline 56‑week LUGANO results in mid‑2026, with LUCIA results to follow closely. The DSMC meets every six months per protocol to monitor participant safety.
Read Announcement- Drug:
- DURAVYU
- Announced Date:
- October 14, 2025
- Target Action Date:
- Q1 2026
- Estimated Target Date Range:
- January 1, 2026 - March 31, 2026
- Indication:
- In patients with non-proliferative diabetic retinopathy (NPDR).
Announcement
EyePoint Pharmaceuticals, Inc announced details for its pivotal Phase 3 program evaluating DURAVYU™ (vorolanib intravitreal insert) for the treatment of diabetic macular edema (DME) with first patient dosing anticipated in first quarter of 2026.
AI Summary
EyePoint Pharmaceuticals announced its pivotal Phase 3 clinical program for DURAVYU™ (vorolanib intravitreal insert) to treat diabetic macular edema (DME), with first patient dosing expected in the first quarter of 2026. The program will include two identical non-inferiority trials, COMO and CAPRI, each enrolling about 240 patients. Both treatment-naïve and previously treated patients will be randomly assigned to a 2.7 mg DURAVYU arm or a 2 mg aflibercept control, with redosing every six months. The primary endpoint is the change from baseline in best corrected visual acuity (BCVA) at weeks 52 and 56 compared to aflibercept.
New preclinical data show that vorolanib blocks vascular endothelial growth factor (VEGF)–mediated leakage and inhibits interleukin-6 (IL-6)–driven inflammation through JAK-1 receptor inhibition. This dual action supports the early and sustained improvements seen in the Phase 2 VERONA trial and highlights DURAVYU as a potential six-month, multi-mechanism treatment option for DME patients.
Read Announcement- Drug:
- DURAVYU
- Announced Date:
- July 29, 2025
- Indication:
- In patients with non-proliferative diabetic retinopathy (NPDR).
Announcement
EyePoint Pharmaceuticals, Inc. announced it has completed enrollment of its Phase 3 pivotal program with the full enrollment of the LUCIA trial, the second of two identical ongoing pivotal non-inferiority trials evaluating DURAVYU™ for the treatment of wet age-related macular degeneration (wet AMD). The first pivotal trial, LUGANO, completed enrollment in May 2025.
AI Summary
EyePoint Pharmaceuticals has finished enrolling the LUCIA trial, the second of two Phase 3 non-inferiority studies testing DURAVYU for wet age-related macular degeneration. The first trial, LUGANO, completed enrollment in May 2025. LUCIA enrolled over 400 patients in seven months, bringing the combined total to more than 800 and making it one of the fastest Phase 3 wet AMD programs.
An independent Data Safety Monitoring Committee reviewed interim safety data and saw no new risks. They confirmed the trials should continue as planned. DURAVYU’s safety profile remained consistent with earlier clinical studies, with no drug-related serious eye or systemic adverse events reported.
EyePoint expects interim data from LUGANO’s 56-week analysis in mid-2026, with LUCIA topline results soon after. Both trials test six-month dosing of DURAVYU versus on-label aflibercept, measuring vision, safety, and treatment burden.
Read Announcement- Drug:
- DURAVYU
- Announced Date:
- May 27, 2025
- Indication:
- In patients with non-proliferative diabetic retinopathy (NPDR).
Announcement
EyePoint Pharmaceuticals, Inc. 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.
AI Summary
EyePoint Pharmaceuticals has surpassed its enrollment target in the Phase 3 LUGANO pivotal trial for DURAVYU™, a sustained-release treatment for wet age-related macular degeneration (wet AMD). More than 400 patients have been enrolled and randomized over a seven-month period—a record pace for a Phase 3 trial in this field. This rapid enrollment reflects strong interest from both physicians and patients, highlighting the significant need for improved treatment options in wet AMD.
The LUGANO trial, which is one of two non-inferiority trials in EyePoint’s Phase 3 program for DURAVYU, aims to assess the drug’s safety and efficacy. With top-line 56-week data expected in mid-2026, the timely progress of this trial, along with the upcoming LUCIA trial enrollment, underscores the potential impact of DURAVYU in transforming the current treatment paradigm for wet AMD.
Read Announcement- Drug:
- DURAVYU
- Announced Date:
- March 5, 2025
- Indication:
- In patients with non-proliferative diabetic retinopathy (NPDR).
Announcement
EyePoint Pharmaceuticals, Inc highlighted recent corporate developments.
AI Summary
EyePoint Pharmaceuticals, Inc. recently announced its financial results for Q4 and the full year ended December 31, 2024, along with key corporate developments. The company emphasized that its sustained delivery therapy, DURAVYU™, is progressing well in clinical trials for two major retinal diseases. The Phase 3 wet AMD trials, LUGANO and LUCIA, are exceeding enrollment expectations, with LUGANO over 50% enrolled and LUCIA recruiting ahead of schedule. Positive Phase 2 data from the VERONA trial in diabetic macular edema also met primary and secondary endpoints. Additionally, EyePoint highlighted its strong financial position, reporting $371 million in cash and investments as of December 31, 2024, which is expected to support operations into 2027. These developments underscore the company’s commitment to advancing DURAVYU™ and position it for potential future regulatory and commercial success.
Read Announcement- Drug:
- DURAVYU
- Announced Date:
- February 25, 2025
- Indication:
- In patients with non-proliferative diabetic retinopathy (NPDR).
Announcement
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.
AI Summary
EyePoint Pharmaceuticals announced that its President and CEO, Dr. Jay S. Duker, will share updates on DURAVYU™ during a corporate presentation. The presentation is set for Tuesday, March 4, 2025 at 9:10 a.m. ET at the TD Cowen 45th Annual Health Care Conference. Dr. Duker will provide an update on enrollment for the ongoing Phase 3 pivotal program of DURAVYU in wet age-related macular degeneration (wet AMD). Additionally, he will discuss subgroup analyses from the Phase 2 VERONA trial, which tested DURAVYU for diabetic macular edema (DME). This update is important as it gives insight into the progress of the clinical trials for DURAVYU, an investigational product aimed at treating serious retinal diseases. The live webcast and archived presentation can be accessed on the company’s website.
Read Announcement- Drug:
- DURAVYU
- Announced Date:
- February 5, 2025
- Target Action Date:
- LATE 2025
- Estimated Target Date Range:
- October 1, 2025 - December 31, 2025
- Indication:
- In patients with non-proliferative diabetic retinopathy (NPDR).
Announcement
EyePoint Pharmaceuticals, Inc Phase 3 non-inferiority pivotal program initiation anticipated by the end of 2025
AI Summary
EyePoint Pharmaceuticals has reported encouraging Phase 2 results for its investigational therapy DURAVYU, a sustained delivery treatment for diabetic macular edema. In the trial, both investigated doses met the primary endpoint by extending the time to a needed supplemental injection compared to the current treatment. In particular, the 2.7mg dose showed early and sustained improvements in vision and retinal anatomy while also reducing the overall treatment burden. The positive outcomes were paired with a favorable safety profile, with no serious ocular or systemic adverse events related to DURAVYU. Building on these promising findings, the company anticipates launching a Phase 3 non-inferiority pivotal clinical program by the end of 2025, aiming to further validate DURAVYU’s potential as a best-in-class treatment option for serious retinal diseases.
Read Announcement- Drug:
- DURAVYU
- Announced Date:
- February 5, 2025
- Indication:
- In patients with non-proliferative diabetic retinopathy (NPDR).
Announcement
EyePoint Pharmaceuticals, Inc announced positive six-month results for the ongoing Phase 2 VERONA clinical trial evaluating DURAVYU™ (vorolanib intravitreal insert), an investigational sustained delivery therapy delivering patent-protected vorolanib, a selective tyrosine kinase inhibitor (TKI) formulated in proprietary bioerodible Durasert E™.
AI Summary
EyePoint Pharmaceuticals announced positive six-month results from the ongoing Phase 2 VERONA trial evaluating DURAVYU™, an investigational sustained delivery therapy that uses patent-protected vorolanib delivered via its proprietary bioerodible Durasert E™ system. Both tested doses, 1.34 mg and 2.7 mg, achieved the primary endpoint by extending the time to the first supplemental injection compared to an aflibercept control. The 2.7 mg dose, in particular, showed an early and sustained improvement in visual acuity with a 7.1-letter gain in BCVA at 24 weeks, along with a 76-micron reduction in central subfield thickness. The study also reported a significant decrease in treatment burden and maintained a favorable safety profile with no observed DURAVYU-related ocular or systemic serious adverse events. These promising outcomes support plans to initiate a Phase 3 non-inferiority pivotal program later in 2025.
Read Announcement- Drug:
- DURAVYU
- Announced Date:
- December 4, 2024
- Indication:
- In patients with non-proliferative diabetic retinopathy (NPDR).
Announcement
EyePoint Pharmaceuticals, Inc announced that the first patient has been dosed in the LUCIA trial, the Company's second global Phase 3 clinical trial of DURAVYU, formerly EYP-1901, for the treatment of wet age-related macular degeneration (wet AMD).
AI Summary
EyePoint Pharmaceuticals has dosed the first patient in the LUCIA trial, its second global Phase 3 study for DURAVYU (formerly EYP-1901) in treating wet age-related macular degeneration (wet AMD). DURAVYU is an investigational therapy that delivers vorolanib steadily through a bioerodible implant. The new trial follows closely on the heels of the ongoing LUGANO trial, demonstrating the company’s strong commitment to exploring sustained drug delivery for retinal diseases. The LUCIA trial aims to gather data on the drug’s safety, effectiveness, and dosing flexibility, potentially easing the treatment burden for wet AMD patients who often require frequent injections. With enthusiastic support from physicians and patients around the globe, EyePoint is optimistic that these Phase 3 trials will help change the current treatment landscape for wet AMD and offer more durable treatment options.
Read Announcement
Eyepoint Pharmaceuticals FDA Events - Frequently Asked Questions
As of now, Eyepoint Pharmaceuticals (EYPT) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Eyepoint Pharmaceuticals (EYPT) has reported FDA regulatory activity for DURAVYU.
The most recent FDA-related event for Eyepoint Pharmaceuticals occurred on May 14, 2026, involving DURAVYU. The update was categorized as "review," with the company reporting: "EyePoint, Inc. 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."
Currently, Eyepoint Pharmaceuticals has one therapy (DURAVYU) targeting the following condition: In patients with non-proliferative diabetic retinopathy (NPDR)..
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FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
FDA progress for NASDAQ:EYPT last updated on 5/14/2026 by MarketBeat.com Staff. We continuously monitor for new FDA events and market data.
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