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EyePoint Pharmaceuticals Announces Completion of Enrollment of Phase 1 DAVIO Clinical Trial of EYP-1901 for the Potential Treatment of Wet AMD

·6 min read

WATERTOWN, Mass., May 25, 2021 (GLOBE NEWSWIRE) -- EyePoint Pharmaceuticals, Inc. (NASDAQ: EYPT), a pharmaceutical company committed to developing and commercializing therapeutics to help improve the lives of patients with serious eye disorders, today announced the completion of patient enrollment of its Phase 1 clinical trial of EYP-1901 as a potential twice-yearly sustained delivery anti-VEGF treatment targeting wet age-related macular degeneration (wet AMD).

“We are pleased to report the completion of enrollment of all three dose cohorts in our ongoing Phase 1 trial of EYP-1901,” said Nancy Lurker, CEO of EyePoint Pharmaceuticals. “EYP-1901 represents an exciting potential advancement for the treatment of wet AMD as a twice-yearly therapy using our proven Durasert® technology that provides reliable, sustained, controlled and consistent zero order kinetics delivery. The completion of enrollment of our Phase 1 trial continues to make us confident that the potential advantages of EYP-1901 are obvious to patients and providers. We remain on track to provide interim data from the trial in the fourth quarter of 2021. We would like to thank our investigators and our internal team for making this enrollment possible and for their continued confidence in EYP-1901.

The ongoing Phase 1 DAVIO trial for EYP-1901 is an open-label twelve-month dose escalation trial examining wet AMD patients who were responsive to previous anti-VEGF therapies. The primary endpoint of the trial is safety and key secondary endpoints are changes in best-corrected visual acuity (BCVA) and central subfield thickness. EYP-1901 is delivered via a single intravitreal injection in the physician's office. The Company anticipates that six-month interim data will include initial safety and efficacy evaluations. More information on the Phase 1 DAVIO trial may be found at www.clinicaltrials.gov (NCT04747197).

About EYP-1901

EYP-1901 is a potential twice-yearly sustained delivery intravitreal anti-VEGF treatment for wet age-related macular degeneration, currently being studied in a Phase 1 clinical trial. EYP-1901 combines a bioerodible formulation of EyePoint’s proprietary Durasert® drug release technology and vorolanib, a tyrosine kinase inhibitor. Durasert provides sustained, controlled and consistent zero order kinetics drug delivery, and vorolanib demonstrated 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 also anticipated to be studied for the potential treatment of diabetic retinopathy and retinal vein occlusion in future clinical trials.

About Wet Age-Related Macular Degeneration

Age-related macular degeneration (AMD) is a condition that affects the part of the eye that provides sharp, central vision needed for normal living activities. Wet AMD is an advanced form of the disease that can cause rapid and severe vision loss. The hallmark of wet AMD is the development of new, abnormal blood vessels in center of the retina resulting in fluid accumulation, bleeding and/or fibrosis. Wet AMD is the leading cause of vision loss in people over the age of 60,and the disease will affect even more people as the global population ages.

About EyePoint Pharmaceuticals, Inc. (Nasdaq:EYPT) is a pharmaceutical company committed to developing and commercializing therapeutics to help improve the lives of patients with serious eye disorders. The Company's pipeline leverages its proprietary Durasert® technology for sustained intraocular drug delivery including EYP-1901, a potential twice-yearly intravitreal anti-VEGF treatment initially targeting wet age-related macular degeneration. The Company has two commercial products: YUTIQ®, for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye, and DEXYCU®, for the treatment of postoperative inflammation following ocular surgery. EyePoint Pharmaceuticals is headquartered in Watertown, Massachusetts. To learn more about the Company, please visit www.eyepointpharma.com and connect on Twitter and LinkedIn.

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 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 expectations regarding the timing and clinical development of our product candidates, including EYP-1901; and 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; 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.

Investors:

Christina Tartaglia
Stern IR
Direct: 212-698-8700
christina.tartaglia@sternir.com

Media Contact

Green Room Public Relations
Caren Begun
Green Room Communications
Direct: (201) 396-8551
caren@greenroompr.com