EyePoint Pharmaceuticals Presents Interim Masked Safety Data and Patient Baseline Characteristics for DAVIO 2 Clinical Trial at OIS Retina Innovation Summit
Interim safety data from the Phase 2 DAVIO 2 trial continues to demonstrate EYP-1901 is well tolerated with no reported drug-related ocular or systemic SAEs
Patient demographics demonstrate the Phase 2 DAVIO 2 population has a better baseline BCVA and decreased CST compared to the Phase 1 DAVIO trial cohort at trial start
Phase 2 DAVIO 2 clinical trial remains on track to report topline data in December 2023
“EYP-1901 continues to demonstrate an excellent safety profile in the Phase 2 DAVIO 2 trial with no reported drug-related ocular serious adverse events (SAEs) and no reported drug-related systemic SAEs in the 160 enrolled patients as of
A masked safety summary as of
- Retinal detachment in a study eye detected at week 1 (one week post initial aflibercept injection, prior to EYP-1901 injection)
- Retinal hemorrhage in a non-study fellow eye
EyePoint also presented the Phase 2 DAVIO 2 trial screening characteristics and provided a comparison to baseline demographics of the Phase 1 DAVIO patients. Interim baseline data on patients in the Phase 2 DAVIO 2 trial as of
DAVIO 2 is a randomized, controlled Phase 2 clinical trial of EYP-1901 in patients with previously treated wet AMD. All enrolled patients had been previously treated with 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 BCVA compared to the aflibercept control, six-months after the EYP-1901 injection. Secondary efficacy endpoints include change in 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).
EYP-1901 is being developed as an investigational sustained delivery treatment for retinal disease 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 Phase 1 DAVIO clinical trial of EYP-1901 in wet AMD showed a positive safety profile with stable visual acuity and OCT. Further, the data demonstrated an impressive treatment burden reduction of 75% at six months and 73% at the 12-month visit following a single dose of EYP-1901. Phase 2 trials are fully enrolled in wet AMD and non-proliferative diabetic retinopathy, and a diabetic macular edema trial is planned for initiation in Q1 2024. 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 sufficiency of our existing cash resources into 2025; our plans and any other statements about future expectations, prospects, estimates and other matters that are dependent upon future events or developments, including statements containing the words “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 our ability to realize the anticipated benefits of the 2023 sale of YUTIQ® to Alimera Sciences including our potential to receive additional payments from Alimera pursuant to the our agreements with Alimera; our ability to manufacture YUTIQ in sufficient quantities pursuant to our commercial supply agreements with Alimera and Ocumension Therapeutics; 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, non-proliferative diabetic retinopathy and diabetic macular edema; 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, including our agreements with Alimera, Ocumension,
Source: EyePoint Pharmaceuticals, Inc.