EyePoint Pharmaceuticals Completes Enrollment in Oversubscribed Phase 2 DAVIO 2 Clinical Trial of EYP-1901 for Maintenance Treatment of Wet AMD
- Significant investigator and patient interest drove strong recruitment, exceeding enrollment goals
- Topline DAVIO 2 data anticipated in Q4 2023
“We are thrilled to announce the completion of enrollment in our oversubscribed Phase 2 DAVIO 2 trial evaluating EYP-1901 in wet AMD, marking an important milestone as we continue to advance our pipeline of innovative sustained delivery treatments for serious eye disorders,” said
“We look forward to reporting topline data in the fourth quarter of this year. With these data and the promising results from our Phase 1 DAVIO trial, EYP-1901 will have the largest and most robust dataset of any tyrosine kinase inhibitor (TKI) product in development for wet AMD. These data will inform the design of our pivotal Phase 3 clinical trials and provide optionality as we seek to bring this promising product to patients. I would like to thank our dedicated team of employees and clinical partners, as well as the patients who enrolled in the Phase 1 and Phase 2 EYP-1901 trials and their caregivers for advancing the development of EYP-1901,” continued
DAVIO 2 is a randomized, controlled Phase 2 clinical trial of EYP-1901 in patients with wet AMD. Originally designed to enroll 144 patients, the trial enrolled 160 patients in total due to strong investigator and patient interest. All enrolled patients were previously treated with a standard-of-care anti-VEGF therapy and were randomly assigned to one of two doses of EYP-1901 (approximately 2 mg or 3 mg) or an aflibercept control. EYP-1901 is delivered with a single intravitreal injection in the physician's office, similar to current FDA approved anti-VEGF treatments. The primary efficacy endpoint of the DAVIO 2 trial is change in best corrected visual acuity (BCVA) compared to the aflibercept control, six-months after the EYP-1901 injection. Secondary efficacy endpoints include change in central subfield thickness (CST) as measured by optical coherence tomography (OCT), number of eyes that remain free of supplemental anti-VEGF injections, number of aflibercept injections in each group, and safety. More information about the trial is available at clinicaltrials.gov (identifier: NCT05381948).
“Our ‘Treat to Maintain’ therapeutic approach for EYP-1901 has the potential to transform the wet AMD treatment paradigm, and we are incredibly pleased to complete enrollment with more patients than planned in the DAVIO 2 clinical trial due to high demand to participate from investigators and patients,” said
Topline data from the Phase 2 DAVIO 2 trial of EYP-1901 in wet AMD is anticipated in Q4 2023.
EYP-1901 is being developed as an investigational sustained delivery treatment combining a bioerodible formulation of EyePoint's proprietary Durasert® delivery technology (Durasert® E) with vorolanib, a tyrosine kinase inhibitor. Positive safety and efficacy data from the DAVIO Phase 1 clinical trial of EYP-1901 showed a positive safety profile with stable visual acuity and OCT. Further, 53% and 35% of eyes did not require any supplemental anti-VEGF injections up to six and twelve months, respectively, following a single dose of EYP-1901. Phase 2 studies are underway for wet AMD and non-proliferative diabetic retinopathy and are planned in diabetic macular edema. Vorolanib is licensed to EyePoint exclusively by Equinox Sciences for the localized treatment of all ophthalmic diseases.
EYEPOINT SAFE HARBOR STATEMENTS UNDER THE PRIVATE SECURITIES LITIGATION ACT OF 1995: To the extent any statements made in this press release deal with information that is not historical, these are forward-looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements regarding the use of proceeds for the offering and other statements identified by words such as “will,” “potential,” “could,” “can,” “believe,” “intends,” “continue,” “plans,” “expects,” “anticipates,” “estimates,” “may,” other words of similar meaning or the use of future dates. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause EyePoint’s actual results to be materially different than those expressed in or implied by EyePoint’s forward-looking statements. For EyePoint, this includes uncertainties regarding the timing and clinical development of our product candidates, including EYP-1901; the potential for EYP-1901 as a novel sustained delivery treatment for serious eye diseases, including wet age-related macular degeneration and non-proliferative diabetic retinopathy; the effectiveness and timeliness of clinical trials, and the usefulness of the data; the timeliness of regulatory approvals; the success of current and future license agreements; our dependence on contract research organizations, co-promotion partners, and other outside vendors and service providers; effects of competition and other developments affecting sales of our commercialized products, YUTIQ® and DEXYCU®; the loss of pass-through reimbursement status for DEXYCU as of
Source: EyePoint Pharmaceuticals, Inc.