EyePoint Pharmaceuticals, Inc. announced positive topline results of its phase 2 DAVIO 2 trial of EYP-1901, an investigational sustained delivery maintenance treatment for wet age-related macular degeneration (wet AMD) combining vorolanib, a selective tyrosine kinase inhibitor with bioerodible Durasert E.
The clinical trial met its primary endpoint with both EYP-1901 doses demonstrating statistical non-inferiority change in best corrected visual acuity (BCVA) compared to aflibercept control and a favorable safety profile with no EYP-1901-related ocular or systemic serious adverse events (SAEs).
The trial also achieved key secondary endpoints with both EYP-1901 doses, including an over 80% reduction in treatment burden, nearly two-thirds of eyes supplement-free up to six months and over 80% receiving only zero or one supplement up to six-months. Additionally, there was strong anatomical control with both EYP-1901 cohorts as measured by optical coherence tomography (OCT).
“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. Since EYP-1901 achieved statistical non-inferiority to the aflibercept control in this trial there is potential for meaningfully lower sized and lower cost pivotal Phase 3 trials,” said Jay S. Duker, MD, President and CEO of EyePoint Pharmaceuticals. “I would like to thank the patients and the investigators who participated in the DAVIO 2 trial as well as our employees who helped advance us to this important milestone.”
Dr. Duker continued, “the DAVIO 2 clinical trial was designed to support the initiation of Phase 3 clinical trials based on feedback received from the U.S. Food and Drug Administration (FDA) at a Type C meeting last year. The 32-week topline DAVIO 2 data strongly supports our planned phase 3 non-inferiority design, consistent with the FDA’s recent guidance for wet AMD clinical trials. We look forward to continuing our dialogue regarding our phase 3 plans with the FDA as we prepare to initiate our first pivotal trial for wet AMD in the second half of 2024.”
“These highly positive phase 2 results are the result of years of hard work by the dedicated EyePoint team coupled with our proven Durasert technology which continues to demonstrate the benefit of zero order kinetics drug delivery. I look forward to initiation of phase 3 and potentially bringing this innovative and much needed new drug to market for patients suffering from these blinding eye diseases,” said Nancy Lurker, executive vice chair of EyePoint Pharmaceuticals. “I want to congratulate the EyePoint team on the continued execution of this program.”
DAVIO 2 topline interim results include:
- Both EYP-1901 doses (2mg and 3mg) achieved all primary and secondary endpoints.
- Statistical non-inferiority in change in BCVA (at a confidence interval of 95%) compared to aflibercept control, at weeks 28 and weeks 32 combined. The 2mg and 3mg doses were only -0.3 and -0.4 letters different, respectively, versus on-label aflibercept. The lower limit of the non-inferiority margin is defined as a -4.5 letters by the FDA with 5 letters representing one line on the eye chart.
- Continued positive safety and tolerability profile with no EYP-1901-related ocular or systemic SAEs.
- 89% and 85% reduction in treatment burden, respectively, for the 2mg and 3mg EYP-1901 doses.
- 65% and 64% of eyes were supplement free up to six-months, respectively, for the 2mg and 3mg doses of EYP-1901.
- Both EYP-1901 doses demonstrated strong anatomic control with OCT difference below 10 microns at week 32 compared to the aflibercept control.
- Patient discontinuation up to week 32 was low at 4%.
“Wet AMD is a prevalent and progressive lifetime disease. With frequent treatment, patients can maintain their visual acuity, but the unfortunate reality is that many patients end up undertreated due to the burden of dosing of the currently available, short-acting anti-VEGF therapies,” said Carl Regillo, MD, chief of Retina Service at Wills Eye Hospital. “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. 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.”