Phase 2 trial of EYP-1901 in wet AMD meets all endpoints
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Key takeaways:
- EYP-1901 demonstrated noninferior change in best corrected visual acuity compared with aflibercept control.
- EyePoint is preparing to initiate a phase 3 pivotal trial in the second half of 2024.
The phase 2 DAVIO 2 trial of EYP-1901 met all primary and secondary endpoints in patients with wet age-related macular degeneration, EyePoint Pharmaceuticals announced in a press release.
Both doses of EYP-1901, vorolanib in sustained-release Durasert E technology, demonstrated noninferior change in best corrected visual acuity compared with aflibercept control.
Image: Adobe Stock
“We are incredibly pleased by these highly positive phase 2 results which underscore EYP-1901’s potential as a paradigm-altering maintenance treatment for patients with wet AMD, with a positive safety profile,” Jay S. Duker, MD, president and CEO of EyePoint, said in the release. “Since EYP-1901 achieved statistical noninferiority to the aflibercept control in this trial, there is potential for meaningfully lower sized and lower cost pivotal phase 3 trials.”
In the trial, 160 patients previously treated with anti-VEGF therapy for wet AMD were randomly assigned to receive 2 mg or 3 mg of EYP-1901 or aflibercept control. At the 6-month endpoint, the 2 mg and 3 mg doses demonstrated a statistically noninferior change in BCVA vs. aflibercept control of –0.3 letters and –0.4 letters, respectively, according to the release.
Secondary endpoints that were met included safety, change in central subfield thickness, the number of eyes that remained free of supplemental anti-VEGF therapy and the number of aflibercept injections in each group.
“The 32-week topline DAVIO 2 data strongly supports our planned phase 3 noninferiority design, consistent with the FDA’s recent guidance for wet AMD clinical trials,” Duker said in the release.
EyePoint plans to initiate a phase 3 pivotal trial of EYP-1901 in wet AMD in the second half of 2024.
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