The first patients have received dosing in two phase 3 global clinical trials evaluating DURAVYU (vorolanib intravitreal insert; also known as EYP-1901) for the treatment of diabetic macular edema (DME).
It’s been a minute since we’ve talked about DURAVYU … how about a refresh?
EyePoint, Inc. is developing the investigational sustained delivery therapy as a small-molecule, selective, and potent pan-vascular endothelial growth factor (VEGF) receptor inhibitor.
Its composition: Consists of a biodegradable formulation of two key components:
- DURASERT E, an injectable, sustained-delivery system for therapeutics
- See here for a rundown on the proprietary technology
- Vorolanib (a tyrosine kinase inhibitor [TKI])
- Has the potential to provide a mechanism of action (MOA) for treating VEGF-mediated retinal diseases—including DME.
And its mode of delivery?
DURAVYU is administered via a single-dose—twice-yearly; at least every 6 months—intravitreal (IVT) injection.
As David Eichenbaum, MD, principal investigator of one of the two phase 3 trials, noted:
- “DURAVYU’s multi-(mechanism of action) uniquely targets inflammation through inhibition of IL-6/JAK1 signaling while also reducing vascular leakage through blocking of all VEGF receptors.”
The supporting clinical data to back this up: Would be early and sustained visual and anatomical improvement observed in the DME-focused phase 2 VERONA trial (but more on that later).
Now, DME isn’t its only potential indication, right?
Correct. The therapeutic is also under clinical investigation for wet age-related macular degeneration (AMD).
The latest on that: We last reported on this indication in October and December 2024 following EyePoint’s dosing of the first patients in its first (LUGANO) and second (LUCIA) global phase 3 trials, respectively.
Duly noted. Now focus on its DME indication.
First, let’s look at the therapeutic’s phase 2 performance in the multicenter, randomized, double-masked, parallel VERONA trial (NCT06099184).
With 6-month findings reported in February 2025, the study met its primary and secondary endpoints in demonstrating:
- Rapid and sustained improvement in vision and anatomy
- Continued favorable safety and tolerability profile with superior dosing intervals to standard of care.
See here for our coverage.
Next up: this pivotal phase 3 program.
DURAVYU’s pivotal phase 3 DME program—which was informed by a positive end-of-phase 2 meeting with the FDA—consists of two global, randomized, double-masked, on-label aflibercept-controlled non-inferiority trials:
- COMO
- CAPRI
Their purpose: Both studies are evaluating DURAVYU’s safety and efficacy in DME patients.
Give me a rundown on how the trials are set up.
First initiated this past fall—and a notable mirror to that of DURAVYU’s wet AMD program—here’s what we know about the COMO and CAPRI studies.
- The participants: An estimated 240 DME patients (including treatment-naïve and previously-treated) in each study
- The setup: Patients will be randomized on Day 1 to either:
- DURAVYU 2.7 mg (with planned redosing every 6 months)
- On-label aflibercept 2 mg
And what are the studies measuring?
The primary endpoint is the blended change from baseline in best-corrected visual acuity (BCVA) at weeks 52 and 56.
The secondary endpoints include:
- Safety
- Superiority in reduction in treatment burden
- Percentage of eyes free of supplemental aflibercept injections
- Anatomical results (measured via optical coherence tomography [OCT])
So! When might we get a data readout?
EyePoint reported plans to release topline data in the second half (H2) of 2027.
Any other target dates in the meantime?
Yes … but for DURAVYU’s wet AMD indication.
That phase 3 program (consisting of the LUGANA and LUCIA trials) is expected to report data “beginning in mid-2026,” according to EyePoint.
Until then … stay tuned!