EyePoint Pharmaceuticals Reports Positive 30-day Safety Results for all Cohorts from the DAVIO Trial of EYP-1901 for wet-AMD
“We are pleased by the 30-day safety data seen for all three cohorts of the EYP-1901 DAVIO trial in patients with wet AMD,” said Nancy Lurker, CEO of EyePoint Pharmaceuticals. “These early results continue to support our belief in the potential of EYP-1901 to be a safe and effective therapeutic for long-term treatment of wet AMD. We are looking forward to releasing interim efficacy results once we have sufficient follow-up data for all dose cohorts in the fourth quarter of this year. Additionally, we continue to progress toward initiating our clinical trials of EYP-1901 for diabetic retinopathy and retinal vein occlusion.”
The DAVIO clinical trial of EYP-1901 enrolled 17 wet AMD patients across three dose cohorts. Key safety observations through at least 30-Day post-dosing follow-up for all patients include:
- No serious adverse events (SAEs), ocular or systemic, were reported
- The three subjects in cohort 1 have been followed for a minimum of four months with no reported SAE’s
- To date, there are no reported adverse events (AEs) related to significant intraocular inflammation, best-corrected visual acuity (BCVA) reduction, or elevation of intraocular pressure (IOP)
- No events of endophthalmitis, retinal detachment or migration into the anterior chamber have been reported to date
The patients enrolled in the Phase 1 DAVIO open-label, dose escalation trial were previously treated with standard of care anti-VEGF therapies. EYP-1901 is delivered via a single intravitreal injection in the physician's office. The primary endpoint of the trial is safety, and key secondary endpoints are best corrected visual acuity (BCVA) and central subfield thickness (CST) as measured by optical coherence tomography (OCT).
EYP-1901 utilizes the Company’s proprietary Durasert® drug delivery technology that has been used in four FDA-approved products, including EyePoint’s YUTIQ® for chronic non-infectious uveitis affecting the posterior segment of the eye.
EYP-1901 is a potential twice-yearly sustained delivery intravitreal anti-VEGF treatment for wet age-related macular degeneration. EYP-1901 combines a bioerodible formulation of EyePoint’s proprietary Durasert® sustained release technology with vorolanib, a tyrosine kinase inhibitor. Vorolanib provided clear efficacy signals in two prior human trials in wet AMD as an orally delivered therapy with no significant ocular adverse events. Preclinical studies of EYP-1901 have shown anti-VEGF activity in disease models of ocular neovascularization and no serious safety issues were observed. EYP-1901 is initially being developed as a treatment of wet AMD, with the potential for additional indications in diabetic retinopathy and retinal vein occlusion.
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 anticipated use of proceeds for the proposed 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 our expectations regarding the timing and clinical development of our product candidates, including EYP-1901; the potential for EYP-1901 as a novel twice-yearly treatment for serious eye diseases, including wet age-related macular degeneration, diabetic retinopathy and retinal vein occlusion; 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; our ability to achieve profitable operations and access to needed capital; fluctuations in our operating results; our ability to successfully produce sufficient commercial quantities of YUTIQ and DEXYCU and to successfully commercialize YUTIQ and DEXYCU in the U.S.; our ability to sustain and enhance an effective commercial infrastructure and enter into and maintain commercial agreements for YUTIQ and DEXYCU; the development of our YUTIQ line extension shorter-duration treatment for non-infectious uveitis affecting the posterior segment of the eye; the success of current and future license agreements, including our agreements with Ocumension Therapeutics and Equinox Science; termination or breach of current license agreements, including our agreements with Ocumension Therapeutics and Equinox Science; 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 products; market acceptance of products; effects of guidelines, recommendations and studies; protection of intellectual property and avoiding intellectual property infringement; retention of key personnel; product liability; industry consolidation; compliance with environmental laws; manufacturing risks; risks and costs of international business operations; volatility of stock price; possible dilution; absence of dividends; 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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Source: EyePoint Pharmaceuticals, Inc.