EYP-1901 for Wet AMD Achieves Primary Endpoint in DAVIO 2 Trial

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Positive topline results from the phase 2 trial indicate EYP-1901 exhibited statistical non-inferiority in BCVA to aflibercept, with a favorable safety profile.

Eye | Image Credit: Unsplash/Perchek Industries

Credit: Unsplash/Perchek Industries

New topline results from the phase 2 DAVIO 2 trial showed EYP-1901, a sustained delivery maintenance treatment combining vorolanib with a bioerodible insert, achieved all primary and secondary endpoints in the treatment of wet age-related macular degeneration (AMD).1

Announced on December 7, 2023, by Eyepoint Pharmaceuticals, EYP-1901 doses demonstrated a statistical non-inferiority change in best-corrected visual acuity (BCVA) compared to aflibercept, with a favorable safety profile identifying no study drug-related ocular or systemic serious adverse events.

“I am very encouraged by the data generated from both the phase 1 DAVIO and phase 2 DAVIO 2 trials with the latter showing essentially no difference in visual outcome at the blended six-month endpoint from a single injection of EYP-1901, compared to on-label, bimonthly aflibercept injections,” said Carl Regillo, MD, the chief of retina service at Wills Eye Hospital, in a statement.1

DAVIO 2 is a randomized controlled phase 2 clinical trial investigating EYP-1901 in previously treated patients with wet AMD. Originally designed to enroll 144 patients, the trial enrolled 160 patients assigned to 2 mg or 3 mg EYP-1901 or an aflibercept control, due to investigator and patient interest.2 Similar to standard-of-care anti-vascular endothelial growth factor (VEGF) agents, EYP-1901 is administered with a single intravitreal injection in a clinic.

Analysis of DAVIO 2 showed both EYP-1901 doses met all primary and secondary endpoints.1 Both EYP-1901 cohorts exhibited a statistically non-inferior change in BCVA versus on-label aflibercept, showing a numerical difference of only -0.3 and -0.4 letters for the 2 mg and 3 mg doses, respectively, at the combined 6-month endpoint. The US Food and Drug Administration (FDA) defines the lower limit of the non-inferiority margin as –4.5 letters.

Results from DAVIO 2 showed a continued positive safety and tolerability profile of EYP-1901. Reports showed an 89% and 85% reduction in treatment burden, respectively, for the 2 mg and 3 mg doses. Patient discontinuation in the trial up to week 32 was reported as only 4%.

Moreover, the study showed 65% and 64% of eyes were supplement free up to 6 months, respectively, for EYP-1901 2mg and 3mg doses. Both dose cohorts demonstrated strong anatomic control with OCT difference below 10 microns at week 32 compared to the aflibercept control.

“Based on the meaningful reduction in treatment burden and supplement-free rates observed, along with the consistently favorable safety profile, I believe that EYP-1901 could be a paradigm shift in how patients with wet AMD are treated,” Regillo said.1

The company has indicated its plan to initiate its first pivotal trial for wet AMD in the latter half of 2024, based on recent guidance from the FDA for wet AMD clinical trials.

“The DAVIO 2 clinical trial was designed to support the initiation of phase 3 clinical trials based on feedback received from the FDA at a Type C meeting last year,” said Jay S. Duker, MD, the president and chief executive officer of Eyepoint Pharmaceuticals.1 “The 32-week topline DAVIO 2 data strongly support our planned phase 3 non-inferiority design, consistent with the FDA’s recent guidance for wet AMD clinical trials.”

References

  1. EyePoint Pharmaceuticals announces positive topline data from the phase 2 davio 2 trial of EYP-1901 in wet AMD achieving all primary and secondary endpoints. EyePoint Pharmaceuticals. December 4, 2023. Accessed December 7, 2023. https://investors.eyepointpharma.com/news-releases/news-release-details/eyepoint-pharmaceuticals-announces-positive-topline-data-phase-2.
  2. EyePoint pharmaceuticals completes enrollment in oversubscribed phase 2 davio 2 clinical trial of EYP-1901 for maintenance treatment of WET AMD. EyePoint Pharmaceuticals. March 27, 2023. Accessed December 7, 2023. https://investors.eyepointpharma.com/news-releases/news-release-details/eyepoint-pharmaceuticals-completes-enrollment-oversubscribed.
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