EyePoint’s DURAVYU Clears Another Key Phase 3 Safety Review in Wet AMD Program

EyePoint Pharmaceuticals has announced another important milestone for its investigational retinal therapy, DURAVYU, as the company advances its pivotal Phase 3 program for wet age-related macular degeneration (wet AMD).

The independent Data Safety Monitoring Committee (DSMC) has completed its third scheduled safety review for the LUGANO and LUCIA Phase 3 trials and recommended that both studies continue without any protocol modifications. The update strengthens confidence in DURAVYU’s safety profile ahead of topline data expected to begin arriving in mid-2026.

DURAVYU Continues to Show Favorable Safety Profile

According to EyePoint, interim masked safety data from both Phase 3 studies remain consistent with earlier clinical findings. No new safety concerns have emerged so far.

The favorable safety profile aligns with data generated from more than 190 patients treated across four completed clinical trials, including multiple Phase 2 studies.

Importantly:

• All active patients in the DURAVYU treatment arm have now reached the Week 32 visit
• Patients received their second DURAVYU dose at Week 32
• More than 35% of patients have already received their third planned dose at Week 56

This marks the final anticipated DSMC review before the release of topline Phase 3 data.

What Makes the LUGANO and LUCIA Trials Important?

The LUGANO and LUCIA studies are identical randomized, double-masked, aflibercept-controlled Phase 3 trials evaluating DURAVYU in patients with active wet AMD.

More than 900 patients have been enrolled across both trials, including:

• Treatment-naïve patients
• Previously treated wet AMD patients

Participants were randomized 1:1 to receive either:

• DURAVYU 2.7 mg every six months
• Standard on-label aflibercept injections

The studies are particularly notable because they are currently the only sustained-release wet AMD pivotal Phase 3 trials evaluating six-month redosing over a two-year period.

A Potential Shift in Wet AMD Treatment Burden

One of the biggest challenges in wet AMD treatment today is the high frequency of anti-VEGF injections required to maintain vision.

DURAVYU aims to address this issue through sustained drug delivery using EyePoint’s proprietary Durasert E technology. The therapy is administered via a standard intravitreal injection in a physician’s office, similar to currently approved anti-VEGF treatments.

If successful, the therapy could significantly reduce treatment burden for patients by extending dosing intervals to every six months.

Primary and Secondary Endpoints of the Phase 3 Program

The primary endpoint for both studies is non-inferiority in average change in best corrected visual acuity (BCVA) at Weeks 52 and 56 compared with baseline.

Secondary endpoints include:

• Safety and tolerability
• Reduction in treatment burden
• Percentage of eyes avoiding supplemental aflibercept injections
• Anatomical improvements measured using optical coherence tomography (OCT)

How DURAVYU Works

DURAVYU combines vorolanib, a selective tyrosine kinase inhibitor (TKI), with the company’s bioerodible Durasert E intravitreal delivery platform.

Unlike conventional anti-VEGF therapies that block VEGF ligands extracellularly, vorolanib works intracellularly and targets multiple disease pathways.

Its mechanism includes inhibition of:

• All VEGF receptors
• PDGFR signaling
• IL-6/JAK1 inflammatory signaling

This broader mechanism may provide both anti-angiogenic and anti-inflammatory benefits.

Preclinical studies have also suggested potential neuroprotective effects in retinal disease models.

Strong Clinical Foundation From Earlier Trials

The ongoing Phase 3 program builds on encouraging data from earlier studies, including:

• DAVIO
• DAVIO 2
• VERONA

In particular, the Phase 2 DAVIO trial reportedly demonstrated statistically positive and clinically meaningful results compared with on-label aflibercept.

The Phase 2 VERONA study in diabetic macular edema (DME) also met both primary and secondary endpoints while showing:

• Rapid visual improvement
• Sustained anatomical control
• Favorable safety profile
• Longer dosing intervals versus standard care

DURAVYU Expansion Into DME

Beyond wet AMD, DURAVYU is also being developed for diabetic macular edema.

Two ongoing Phase 3 studies:

• COMO
• CAPRI

are currently recruiting patients.

EyePoint expects data from the DME Phase 3 program during the second half of 2027.

Why This Matters?

The latest DSMC recommendation represents an important de-risking event for EyePoint’s retinal pipeline.

With more than 900 patients enrolled and no major safety concerns reported so far, DURAVYU continues to position itself as a potentially differentiated long-acting retinal therapy.

If the Phase 3 data confirm efficacy alongside six-month dosing, DURAVYU could emerge as a strong competitor in the rapidly evolving wet AMD market, where reducing injection frequency remains one of the industry’s biggest unmet needs.

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