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 and EYP-1901. 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 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
- Estimated Event Date Range:
- October 1, 2025 - December 31, 2025
- Target Action Date:
- LATE 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- Drug:
- DURAVYU
- Announced Date:
- May 6, 2024
- Indication:
- In patients with non-proliferative diabetic retinopathy (NPDR).
Announcement
EyePoint Pharmaceuticals, Inc. announced topline results of its Phase 2 PAVIA clinical trial evaluating DURAVYU™ (vorolanib intravitreal insert), previously known as EYP-1901, in patients with non-proliferative diabetic retinopathy (NPDR).
AI Summary
EyePoint Pharmaceuticals recently announced topline results from its Phase 2 PAVIA clinical trial evaluating DURAVYU™, an intravitreal insert delivering the drug vorolanib, for patients with non-proliferative diabetic retinopathy (NPDR). Although the trial did not meet its primary endpoint, the data showed that DURAVYU is effective in stabilizing or improving disease severity and reducing the progression of NPDR at nine months. In the trial, 86% of patients in the 3mg arm and 80% in the 2mg arm experienced stable or improved disease compared to 70% in the control group. Additionally, the safety profile was favorable with no drug-related serious adverse events reported, suggesting that the treatment is well tolerated. EyePoint plans to further analyze the 12-month data to better understand DURAVYU’s potential as a treatment option for NPDR.
Read Announcement
EYP-1901 - FDA Regulatory Timeline and Events
EYP-1901 is a drug developed by Eyepoint Pharmaceuticals for the following indication: Wet age-related macular degeneration (AMD).
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:
- EYP-1901
- Announced Date:
- June 26, 2024
- Estimated Event Date Range:
- July 1, 2024 - December 31, 2024
- Target Action Date:
- H2 2024
- Indication:
- Wet age-related macular degeneration (AMD)
Announcement
EyePoint Pharmaceuticals, Inc announced that Phase 3 trial design for the LUGANO and LUCIA pivotal non-inferiority trials of DURAVYU in wet AMD based on positive EOP2 meeting with FDA; on track for trial initiation in 2H 2024
AI Summary
EyePoint Pharmaceuticals announced a positive update on the design of its Phase 3 trials for DURAVYU in wet age-related macular degeneration (AMD). The company has established the trial design for the LUGANO and LUCIA pivotal non-inferiority studies based on a favorable End-of-Phase 2 meeting with the FDA. These trials will compare a 2.7 mg dose of DURAVYU to the approved treatment, aflibercept, after an initial loading phase. Approximately 400 patients with active wet AMD, including both previously treated and treatment-naïve individuals, are expected to be enrolled in each trial. Key design elements include a redosing strategy that aligns with how the drug would be used in commercial practice. The LUGANO trial in the US is on track to begin patient dosing in the second half of 2024, with the LUCIA trial to follow soon after.
Read Announcement- Drug:
- EYP-1901
- Announced Date:
- June 26, 2024
- Indication:
- Wet age-related macular degeneration (AMD)
Announcement
EyePoint Pharmaceuticals, Inc announced the Company will highlight clinical and regulatory developments for its lead pipeline program, DURAVYU™ (vorolanib intravitreal insert), formerly known as EYP-1901, its Durasert E™ sustained drug delivery technology, and early-stage programs during EyePoint's R&D Day today, Wednesday, June 26, 2024, from 8:00 a.m. to 9:30 a.m. ET
AI Summary
EyePoint Pharmaceuticals announced that it will showcase key developments for its lead pipeline program, DURAVYU™ (vorolanib intravitreal insert, formerly EYP-1901), at its R&D Day today, June 26, 2024, from 8:00 a.m. to 9:30 a.m. ET. During the event, the company’s management and key opinion leaders will discuss clinical and regulatory milestones achieved with DURAVYU, which utilizes its Durasert E™ sustained drug delivery technology. The presentation will cover recent positive twelve-month safety and efficacy data from the Phase 2 DAVIO 2 trial for treating wet age-related macular degeneration (wet AMD), as well as plans for upcoming Phase 3 pivotal trials in wet AMD. These trials, titled LUGANO and LUCIA, include non-inferiority endpoints and redosing strategies consistent with expected commercial use. The R&D Day highlights underscore the company’s commitment to advancing innovative treatments for serious retinal diseases.
Read Announcement
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