Duravyu for DME meets primary, secondary endpoints in phase 2 trial
Key takeaways:
- Duravyu achieved extended time to first supplemental injection vs. aflibercept.
- It also yielded improvements in best corrected visual acuity and central subfield thickness.
Duravyu at two dose levels met its primary endpoint in the treatment of diabetic macular edema in a phase 2 clinical trial, according to a press release from EyePoint Pharmaceuticals.
“Duravyu (EYP-1901) features vorolanib, which blocks the activity of all isoforms of VEGF by blocking all VEGF receptors,” Jay S. Duker, MD, president and CEO of EyePoint, told Healio. “Due to the unique design, the drug release is constant for at least 6 months. This should enable the majority of DME patients to enjoy stable vision with fewer visits and injections.”
In the randomized, controlled, single-masked, open-label phase 2 VERONA trial, 27 patients with DME who were previously treated with anti-VEGF therapy were randomly assigned to treatment with either 1.34 mg or 2.7 mg Duravyu (vorolanib intravitreal insert) or aflibercept control. The primary endpoint was extended time to first supplemental injection vs. aflibercept, while key secondary endpoints included safety, mean changes in best corrected visual acuity and central subfield thickness (CST), and change in Diabetic Retinopathy Severity Scale over time.
According to the release, both doses achieved the primary endpoint, with visual and anatomical gains observed at week 4. Duravyu 2.7 mg demonstrated a 24-week BCVA gain of 7.1 letters from baseline and a CST improvement of 75.9 µm, “representing 74% more drying in Duravyu eyes vs. aflibercept control.”
In addition, 73% of eyes in the 2.7 mg arm were supplement-free up to week 24 compared with 50% in the control arm, with a reduction in treatment burden of more than two-thirds, the release said.
Duravyu’s safety profile was positive, with no ocular or systemic serious adverse events related to the treatment.
“The current standard of care for patients with DME requires frequent intravitreal injections at the doctor’s office, usually for years. Due to the visit burden, this results in missed visits and chronic undertreatment in about half of all DME patients,” Duker told Healio. “We believe that Duravyu has the potential to extend dosing intervals while maintaining the patient’s vision without sacrificing anatomy — enabling ophthalmologists to have more flexibility in dosing, with fewer visits and less frequent injections.”
EyePoint anticipates initiating a phase 3 noninferiority pivotal program in DME by the end of the year.
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