Phase 2 nonproliferative diabetic retinopathy trial misses primary endpoint
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Key takeaways:
- The trial did not reach a two-step or greater improvement in DRSS at 36 months after Duravyu injection.
- Stable or improved disease was seen in 86% of patients in the 3 mg arm and 80% of patients in the 2 mg arm.
SEATTLE — The phase 2 PAVIA trial investigating Duravyu, previously known as EYP-1901, for the treatment of nonproliferative diabetic retinopathy did not meet its primary endpoint, according to a press release from EyePoint Pharmaceuticals.
“Although the phase 2 PAVIA clinical trial did not meet the prespecified primary endpoint of improvement of at least two Diabetic Retinopathy Severity Scale (DRSS) levels at week 36 after Duravyu injection, Duravyu continues to be well tolerated with no drug-related serious adverse events and appears to reduce rates of NPDR progression at 9 months,” Jay S. Duker, MD, CEO of EyePoint Pharmaceuticals, told Healio.
The trial included 77 patients with moderately severe to severe nonproliferative diabetic retinopathy (NPDR) who were randomly assigned to a 2 mg or 3 mg dose of Duravyu (vorolanib intravitreal insert) or a control arm that received a sham injection.
At 9 months, 86% of patients in the 3 mg arm and 80% of patients in the 2 mg arm demonstrated “stable or improved disease” compared with 70% of patients in the control arm, according to the release. Ten percent of patients in the control arm worsened two steps or more at 9 months compared with 5% of patients in the 2 mg arm and no patients in the 3 mg arm.
Five percent of patients in the 3 mg arm and no patients in the 2 mg arm achieved a two-step or greater improvement in DRSS score at 9 months compared with 5% of patients in the control arm.
There were no reports of endophthalmitis or retinal vasculitis.
“EyePoint plans to analyze the full 12-month data in Q3 2024 once it is available to gain the clarity needed to assess the future of Duravyu as a potential treatment for NPDR,” Duker said.
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