EyePoint Pharmaceuticals Reports Positive Interim Safety and Efficacy Data from Phase 1 DAVIO Clinical Trial Evaluating EYP-1901 for the Treatment of Wet AMD
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"We are very encouraged by these data that reinforce EYP-1901's positive safety profile and its durable anti-VEGF activity up to six months so far in the majority of enrolled patients after a single intravitreal injection," said Nancy Lurker, Chief Executive Officer of EyePoint Pharmaceuticals. "Wet AMD is a leading cause of blindness, and these data bring us one step closer to potentially changing the standard of care for patients by offering an in-office sustained delivery treatment option with the potential for up to every six-month dosing."
The Phase 1 DAVIO clinical trial is an open-label, dose escalation clinical trial of EYP-1901 that enrolled 17 patients with previously treated wet AMD. EYP-1901 is a sustained delivery anti-VEGF (voralanib) investigational treatment that utilizes a bioerodible formulation of EyePoint's Durasert® drug delivery technology that has been utilized in four FDA-approved products, including EyePoint's YUTIQ® for chronic non-infectious uveitis affecting the posterior segment of the eye.
Six-month interim data from the Phase 1 DAVIO clinical trial show no reports of ocular SAEs or drug-related systemic SAEs. Further, there were no reported adverse events such as vitreous floaters, endophthalmitis, retinal detachment, implant migration in the anterior chamber, retinal vasculitis, or posterior segment inflammation. These data showed 76% and 53% of patients did not require rescue following a single dose of EYP-1901 up to four and six months, stable and sustained BCVA (-2.5 letters) and CST (-2.7 μm), a 79% reduction in treatment burden at six months, and a median time to rescue of six months across all patients.
"We are grateful to the patients, investigators, and site staff who are participating in the DAVIO Phase 1 trial. We are very encouraged by today's data results, which demonstrated the safety and sustained anti-VEGF activity of EYP-1901 in wet AMD patients," said
"Our clinical trial includes patients with previously treated wet AMD, who received frequent anti-VEGF injections prior to entering DAVIO. We were thrilled to see how well tolerated the EYP-1901 inserts appear to be and how well patients responded to EYP-1901 for both vision and anatomical endpoints over the six-month interim report of this 12-month study. These results are not only promising as we plan to move EYP-1901 into Phase 2 in wet AMD, but also for the potential to change the treatment paradigm for many wet AMD patients," said
EyePoint plans to initiate a Phase 2 wet AMD clinical trial in 2022 and the Company has scheduled a Type C meeting with the FDA on
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EYP-1901 is an investigational agent combining a bioerodible formulation of EyePoint's proprietary Durasert® sustained release technology with vorolanib, a tyrosine kinase inhibitor. Vorolanib provided efficacy signals in two prior human trials in wet AMD as an orally delivered therapy with no significant ocular adverse events. Interim six-month data from the ongoing Phase 1 DAVIO clinical trial of EYP-1901 show no reports of ocular serious adverse events (SAEs) or drug-related systemic SAEs and efficacy data up to six months in the majority of enrolled patients after a single intravitreal injection. EYP-1901 is initially being developed as a treatment for wet AMD, with the potential for additional indications in DR and RVO.
About Wet AMD
AMD impacts as many as 11 million Americans, and up to 15 percent of those patients are impacted by the wet form of AMD, which can lead to blindness. With the current standard of care requiring monthly or bimonthly intravitreal injections, treatment adherence remains an ongoing challenge for patients and physicians.
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 potential for EYP-1901 as a twice-yearly sustained delivery intravitreal anti-VEGF treatment targeting wet AMD, with potential in DR and RVO; our expectations regarding the timing and outcome of our Phase 1 DAVIO clinical trial for EYP-1901 for the potential treatment of wet AMD; our expectations regarding the timing and clinical development of our product candidates, including EYP-1901 and YUTIQ 50; and the potential advantages of our product candidates for the treatment of eye diseases; 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 effectiveness and timeliness of clinical trials, and the usefulness of the data; the timeliness of regulatory approvals; the continued impact of the COVID-19 pandemic on EyePoint's business, the medical community and the global economy and the impact of general business and economic conditions; the success of current and future license agreements; protection of our intellectual property and avoiding 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, anticipated or implied in any forward-looking statement 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, anticipated or implied in our forward-looking statements. Should known or unknown risks materialize, or should underlying assumptions prove inaccurate, actual results could differ materially from past results and those anticipated, estimated or projected in the forward-looking statements. You should bear this in mind as you consider any forward-looking statements. Our forward-looking statements speak only as of the dates on which they are made. We do not undertake any obligation to publicly update or revise our forward-looking statements even if experience or future changes makes it clear that any projected results expressed or implied in such statements will not be realized.
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