Published in Pipeline

EyePoint releases positive 6-month data from phase 2 DME trial

Alex Delaney-Gesing

This is editorially independent content
6 min read

EyePoint Pharmaceuticals, Inc. reported positive 6-month results from its ongoing phase 2 VERONA clinical trial investigating DURAVYU (vorolanib intravitreal insert) for the treatment of diabetic macular edema (DME).

These findings join the company’s already extensive clinical trial dataset evaluating this investigational asset’s potential for treating a range of serious retinal diseases.

Let’s start with DURAVYU.

Originally dubbed “EYP-1901,” the small-molecule, selective, and potent pan-vascular endothelial growth factor (VEGF) receptor inhibitor is in development as a potential sustained-delivery maintenance treatment for the following VEGF-mediated retinal diseases:

  • DME (as a 6-month maintenance therapy)
  • Wet age-related macular degeneration (AMD; as a 6-month maintenance therapy)

To note: The asset was also previously evaluated for nonproliferative diabetic retinopathy (NPDR); however, EyePoint reported in May 2024 that the phase 2 PAVIA study failed to meet its primary goal.

So how does it work?

DURAVYU encompasses a bioerodible formulation of DURASERT E (EyePoint’s proprietary delivery technology) and vorolanib.

About these:

  • DURASERT E is a miniaturized, injectable, sustained-delivery system designed to provide a continuous, stable release of therapeutics within the eye over an extended period of time (weeks, months—and potentially even years).
  • Vorolanib is a tyrosine kinase inhibitor (TKI) that enables potent and selective pan-VEGF receptor inhibition by blocking the downstream signaling of all three VEGF receptors.

And its dosing schedule?

For both DME and wet AMD, DURAVYU is designed as a twice-yearly, single-dose intravitreal (IVT) injection.

Alrighty, now let’s talk clinical data.

This phase 2 VERONA trial (NCT06099184) was a multicenter, prospective, randomized, double-masked, parallel trial evaluating DURAVYU versus aflibercept for DME.

The setup:

  • Participants: 27 patients (aged 18+) diagnosed with DME
    • Note: Clinical Trials reports 25; however, that number was updated by EyePoint
  • The design: Patients randomized into one of three groups to receive, via IVT administration, either:
    • DURAVYU (1343 µg [1.34 mg])
    • DURAVYU (2686 µg [2.7 mg])
    • Aflibercept (2 mg)
  • The outcome measures (measured at Week 24):
    • Primary: Time to supplemental aflibercept injection after DURAVYU dose at baseline versus aflibercept
    • Secondary:
      • Safety
      • Mean change in best-corrected visual acuity (BCVA)
      • Mean change in central subfield thickness (CST)
      • Change in Diabetic Retinopathy Severity Scale (DRSS) over time

And the 6-month data?

Note: The data cut-off date for the following results was Jan. 16, 2025.

Overall: The study met its primary endpoint with extended time to the first supplemental injection for both DURAVYU doses.

Plus: Clinically meaningful outcomes were demonstrated, including for continued safety:

  • No DURAVYU-related ocular or systemic serious adverse events (AEs)
  • Early and sustained improvement in vision and anatomical control

How about some specifics on BCVA and CST?

DURAVYU 2.7 mg demonstrated an “early and sustained improvement” in BCVA and CST (measured via optical coherence tomography [OCT])—as evidenced below:

  • BCVA improved +7.1 letters (compared to baseline)
  • CST improved 7.59 µm
    • Compared to baseline “representing 74% more drying in DURAVYU eyes versus aflibercept”

Additionally: At Week 4, visual and anatomical outcomes demonstrated DURAVYU’s “immediate bioavailability,” EyePoint reported.

Did any participants go supplement-free?

By Week 24, a total of 73% of eyes in the DURAYVU 2.7 mg arm and just 50% in the aflibercept arm.

Also for the DURAVYU 2.7 mg arm: An over 66% reduction in treatment burden was recorded.

And how about adverse events?

DURAVYU demonstrated a positive safety profile, with no reports of:

  • DURAVYU-related ocular or systemic serious AEs
  • Endophthalmitis
  • Impaired vision
  • Insert migration
  • Intraocular inflammation
  • Retinal vasculitis (including occlusive and non-occlusive)

So how does this data compare to previous?

Though not for a DME indication, the phase 2 DAVIO 2 trial (NCT05381948)—which evaluated DURAVYU for wet AMD—not only met its primary endpoint, but also found:

  • Both DURAVYU doses demonstrated a “statistical non-inferiority change in BCVA compared to aflibercept”
  • DURAVYU demonstrated a favorable safety profile
  • Over 80% reduction in treatment burden for DURAVYU-treated patients
  • Over 80% of DURAVYU-treated patients received zero or one supplemental injection up to 6 months

See here for more data.

Nice! And what’s the significance of these latest findings?

EyePoint Chief Medical Officer Ramiro Ribeiro, MD, PhD, stated: “The magnitude of these results gives us confidence moving forward into a phase 3 noninferiority program with a differentiated treatment for patients with DME who need effective, safe and durable treatment options.”

President and CEO Jay S. Duker, MD, added that the results “support a noninferiority pivotal program in DME, and we plan to meet with the FDA in the second quarter for potential initiation of a phase 3 clinical trial later in 2025.”

How exciting! Lastly, what’s next for this candidate?

Aside from that potential phase 3 trial for a DME indication, DURAVYU is currently undergoing clinical evaluation in the following global multicenter, prospective randomized, double-masked, and aflibercept-controlled phase 3 trials for wet AMD:

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