- Significant interest from investigators and patients led to strong enrollment and exceeded enrollment targets
- DAVIO 2 Key Data forecast for Q4 2023
WATERTOWN, Mass., March 27, 2023 (GLOBE NEWSWIRE) -- EyePoint Pharmaceuticals, Inc. (NASDAQ: EYPT), a company dedicated to developing and commercializing therapies to improve the lives of patients suffering from serious eye conditions announced today that it has completed enrollment in the Phase 2 Durasert® and Vorolanib in Ophthalmology 2 (DAVIO 2 ) clinical trial evaluating EYP-1901 as a potential six-month maintenance treatment for wet age-related macular degeneration (AMD). The study exceeded its original target of 144 patients and enrolled a total of 160 patients. All patients were previously treated with standard anti-VEGF therapy and were randomly assigned to receive one of two labeled doses of EYP-1901 or an aflibercept control.
“We are pleased to announce the completion of enrollment for our oversubscribed Phase 2 DAVIO 2 study evaluating EYP-1901 in wet AMD, which represents an important milestone as we sustainably advance our portfolio of innovative delivery treatments for ocular diseases. said Nancy Lurker, CEO of EyePoint Pharmaceuticals. “Wet AMD patients face an immense treatment burden and require monthly or bi-monthly eye injections for the rest of their lives to prevent severe vision loss. The strong interest shown by patients and physicians in participating in the study further demonstrates the great unmet need in this population for a safe, effective, long-lasting, and convenient maintenance treatment option.”
“We expect to release top-line data in the fourth quarter of this year. With these data and the encouraging results from our Phase 1 DAVIO study, EYP-1901 will have the largest and most robust dataset of any tyrosine kinase inhibitor (TKI) product in development for wet AMD. This data will inform the design of our pivotal phase 3 clinical trials and provide options as we seek to bring this promising product to patients. I would like to thank our dedicated team of clinical staff and partners, as well as the patients who enrolled in the Phase 1 and Phase 2 studies of EYP-1901, and their caregivers for promoting the development of EYP-1901,&CloseCurlyDoubleQuote ; Mrs Mirón continued.
DAVIO 2 is a Phase 2 randomized controlled clinical trial of EYP-1901 in patients with wet AMD. Originally designed to enroll 144 patients, a total of 160 patients were enrolled in the study due to strong investigator and patient interest. All enrolled patients were previously treated with standard anti-VEGF therapy and were randomized to receive one of two doses of EYP-1901 (approximately 2 mg or 3 mg) or an aflibercept control. EYP-1901 will be administered as 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 study is the change in best corrected visual acuity (BCVA) compared to aflibercept control six months after EYP-1901 injection. Secondary efficacy endpoints include change in central subfield thickness (CST) as measured by optical coherence tomography (OCT), number of eyes relieved of additional anti-VEGF injections, number of aflibercept injections in each group, and safety . More information about the study can be found at Clinicaltrials.gov (ID: NCT05381948).
“Our attempt to keep and close CurlyQuote; EYP-1901's therapeutic approach has the potential to change the paradigm of wet AMD treatment and we are very pleased to complete enrollment into the larger than expected DAVIO 2 clinical trial given the demand for investigators and patients is very high. ” said Jay Duker, M.D., President and Chief Operating Officer of EyePoint Pharmaceuticals. “The compelling results from DAVIO Phase 1 demonstrate the potential of EYP-1901’ Most patients transitioned to 6 months of treatment for wet AMD, which is “maintenance” treatment. Therapy approach using EYP-1901 as background therapy after application of large molecule anti-VEGF with the goal of significantly prolonging the patient's treatment interval. Based on extensive past clinical data evaluating Durasert in four FDA-approved indications, we are confident that EYP-1901’ to consistently deliver the active drug vorolanib with zero-order drug-release kinetics using our bioerodible sustained-release technology, Durasert®E. Additionally, vorolanib offers a novel mechanism of action for patients with wet AMD and may have additional neuroprotective benefits. We are convinced of the potential of EYP-1901’ to improve adherence to therapy, improve clinical experience and ultimately achieve better patient outcomes.”
Key data from the DAVIO 2 Phase 2 test of EYP-1901 in wet AMD is expected in Q4 2023.
About EYP-1901
EYP-1901 is being developed as an experimental maintenance-dose treatment combining Durasert's proprietary biodegradable formulation®Delivery Technology (Durasert®E) with vorolanib, a tyrosine kinase inhibitor. Positive safety and efficacy data from DAVIO's Phase 1 clinical trial of EYP-1901 demonstrated a positive safety profile with stable visual acuity and OCT. In addition, 53% and 35% of the eyes required up to six and 6 eyelids, respectively, after a single dose of EYP-1901 No additional anti-VEGF injections for 12 months. Phase 2 trials in wet AMD and nonproliferative diabetic retinopathy are ongoing and planned for diabetic macular edema. Vorolanib has been licensed exclusively to EyePoint by Equinox Sciences for the localized treatment of all eye disorders.
Sobre EyePoint Pharmaceuticals
EyePoint Pharmaceuticals (Nasdaq: EYPT) is a company dedicated to the development and commercialization of therapies to improve the lives of patients suffering from serious eye diseases. The company's project portfolio leverages its Durasert® Sustained Intraocular Drug Delivery Technology Including EYP-1901, an Investigational Intravitreal Anti-VEGF Treatment Currently in Phase 2 Clinical Trials, Including YUTIQ® for the treatment of posterior segment uveitis currently marketed by the Company. EyePoint Pharmaceuticals is headquartered in Watertown, Massachusetts.
EYEPOINT SAFE HARBOR STATEMENTS PURSUANT TO THE PRIVATE SECURITIES DISPUTES ACT OF 1995: Statements made in this press release that are not historical information constitute forward-looking statements within the meaning of the Security of 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” "next,” "Plans,” "wait,” "anticipate,” "Estimates,” "can,” other words with a similar meaning or the use of data in the future. By their nature, forward-looking statements address matters that are, to varying degrees, uncertain. Uncertainties and risks could cause the actual results of EyePoint’ materially from the forward-looking statements of EyePoint’ expressed or implied. For EyePoint, this includes uncertainties about the timing and clinical development of our product candidates, including EYP-1901; the potential of EYP-1901 as a new long-acting drug for serious eye diseases, including wet age-related macular degeneration and nonproliferative 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 third party vendors and service providers; Impact of competition and other developments affecting the sale of our marketed products, YUTIQ® and DEXYCU®; the loss of ticket refund status to DEXYCU as of January 1, 2023; market acceptance of our products; product liability; industry consolidation; compliance with environmental laws; risks and costs of international business operations; stock price volatility; possible dilution; absence of dividends; the potential impact of the COVID-19 pandemic on EyePoint's business, the medical community and the global economy; the impact of instability on general business and economic conditions, including changes in inflation, interest rates and the labor market; protect our intellectual property and prevent intellectual property infringement; retention of key personnel; manufacturing risks; and other factors described in our filings with the Securities and Exchange Commission. We cannot guarantee that the results and other expectations expressed, expected or implied by any forward-looking statements will be realized. A variety of factors, including these risks, could cause our actual results and other expectations to differ materially from the anticipated results or other expectations expressed, expected or implied in our forward-looking statements. Should known or unknown risks materialize, or underlying assumptions prove inaccurate, actual results could differ materially from previous results and from those anticipated, estimated or projected in the forward-looking statements. You should consider this when considering any forward-looking statements. Our forward-looking statements speak only as of the date they are made. EyePoint undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
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