WATERTOWN, Mass., April 18, 2018 (GLOBE NEWSWIRE) -- EyePoint Pharmaceuticals (NASDAQ:EYPT) (ASX:PVA), a specialty biopharmaceutical company committed to developing and commercializing innovative ophthalmic products, today announced that two abstracts supporting the Company's YUTIQ™ (fluocinolone acetonide intravitreal implant) 0.18 mg three-year micro-insert for noninfectious posterior segment uveitis have been accepted for presentation at the Association for Research in Vision and Ophthalmology (ARVO) 2018 Annual Meeting being held in Honolulu, Hawaii, from April 29 - May 3, 2018.
- The abstract accepted for a paper presentation is titled "Safety and Efficacy of an intravitreal 0.18 mg fluocinolone acetonide insert (FAi) for the treatment of non-infectious posterior segment uveitis (NIPU) - pooled results of two phase 3 trials". The data will be presented by Eric Suhler, M.D., Casey Eye Institute-OHSU and VA Portland HCS, Portland, Oregon, during the session titled: "Advances in Clinical Therapeutics for Uveitis" on Thursday, May 3, 2018, from 12:00 p.m. to 12:15 p.m. HST.
- The abstract accepted for a poster presentation is titled "Controlling Posterior Segment Uveitic Recurrences: Results from a Phase 3 Study of 0.18 mg fluocinolone acetonide insert (FAi) in subjects with chronic non-infectious
uveitis affecting the posterior segment". The data will be presented by Quan Nguyen, M.D., Byers Eye Institute, Stanford University, Palo Alto, California, during the session titled "Uveitis and Scleritis: Therapeutics" on Sunday, April 29, 2018, from 1:00 p.m. to 2:45 p.m. HST.
"ARVO is one of the most important ophthalmology conferences of the year and we are extremely pleased that data from our YUTIQ Phase 3 studies has been selected for presentations at ARVO and we look forward to sharing the data with retinal and uveitis specialists," commented Nancy Lurker, President and Chief Executive Officer. "Our NDA for YUTIQ for the treatment of noninfectious posterior segment
uveitis is currently under review by the FDA with a PDUFA date of November 5, 2018. We believe that, if approved, YUTIQ has the potential to become an important new treatment option for the thousands of patients suffering from this disease, which is the third leading cause of blindness."
About Noninfectious Posterior Segment Uveitis
Noninfectious posterior segment uveitis is a chronic inflammatory disease affecting the posterior segment of the eye, often involving the retina, which is believed to be a leading cause of blindness in the developed and developing countries. It affects people of all ages, producing swelling and destroying eye tissues, which can lead to severe vision loss and blindness. In the U.S., posterior segment uveitis affects between 80,000 -
100,000 people. Today, patients with posterior uveitis are typically treated with systemic steroids, but over time frequently develop serious side effects that can limit effective dosing. Patients then often progress to steroid-sparing therapy with systemic immune suppressants or biologics, which themselves can have severe side effects including an increased risk of cancer.
About EyePoint Pharmaceuticals
EyePoint Pharmaceuticals (formerly pSivida Corp.) (www.eyepointpharma.com), headquartered in Watertown, MA, is a specialty biopharmaceutical company committed to developing and commercializing innovative ophthalmic products in indications with high unmet medical need to help improve the lives of patients with serious eye disorders. The Company has developed three of only four FDA-approved sustained-release treatments for back-of-the-eye diseases. In addition, DEXYCU™ (dexamethasone intraocular suspension) 9% was approved by U.S. Food and Drug Administration (FDA) on February 9, 2018. DEXYCU is administered as a single intraocular dose at the end of ocular surgery for postoperative inflammation and it is the first and only FDA approved intraocular product with this indication. ILUVIEN® (fluocinolone acetonide intravitreal implant), a micro-insert for diabetic macular edema,
licensed to Alimera Sciences, is currently sold directly in the U.S. and several EU countries. Retisert ® (fluocinolone acetonide intravitreal implant), for posterior uveitis, is licensed to and sold by Bausch & Lomb. The New Drug Application (NDA) for our lead product candidate, YUTIQ™ micro-insert for the treatment of non-infectious uveitis affecting the posterior segment of the eye, has been accepted for filing by the FDA and is currently under standard review with a Prescription Drug User Fee Act (PDUFA) date of November 5, 2018. The Company's pre-clinical development program is focused on using its core Durasert platform technology to deliver drugs to treat wet age-related macular degeneration, glaucoma, osteoarthritis and other diseases. To learn more about the Company, please visit www.eyepointpharma.com and connect on Twitter, LinkedIn, Facebook and Google+.
SAFE HARBOR STATEMENTS UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995: Various statements made in this release are forward-looking, and are inherently subject to risks, uncertainties and potentially inaccurate assumptions. All statements that address activities, events or developments that we intend, expect or believe may occur in the future are forward-looking statements. Some of the factors that could cause actual
results to differ materially from the anticipated results or other expectations expressed, anticipated or implied in our forward-looking statements include uncertainties with respect to: our ability to achieve profitable operations and access to needed capital; fluctuations in our operating results; successful commercialization of, and receipt of revenues from, ILUVIEN® for diabetic macular edema ("DME"), which depends on Alimera's ability to continue as a going concern; Alimera's ability to obtain marketing approvals and the effect of pricing and reimbursement decisions on sales of ILUVIEN; the number of clinical trials and data required for the Durasert technology for the treatment of non-infectious uveitis affecting the posterior segment of the eye, uveitis marketing application approval in the U.S.; our ability to use data in
promotion for YUTIQ micro-insert for the treatment of noninfectious uveitis affecting the posterior segment of the eye, U.S. NDA approval which includes clinical trials outside the U.S.; our ability to successfully commercialize DEXYCU in the U.S.; our ability to obtain stockholder approval for portions of the EW and SWK investments; our ability to successfully commercialize YUTIQ three-year uveitis, if approved, in the U.S.; potential off-label sales of ILUVIEN for uveitis; consequences of fluocinolone acetonide side effects; the development of our next-generation Durasert shorter-duration treatment for posterior segment uveitis; potential declines in Retisert
® royalties; efficacy and the future development of an implant to treat severe osteoarthritis; our ability to successfully develop product candidates, initiate and complete clinical trials and receive regulatory approvals; our ability to market and sell products; the success of current and future license agreements, including our agreement with Alimera; termination or breach of current license agreements, including our agreement with Alimera; our dependence on contract research organizations, vendors and investigators; 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; effects of the potential U.K. exit from the EU; legislative or regulatory changes; volatility of stock price; possible dilution; absence of dividends; and other factors described in our filings with the Securities and Exchange Commission. You should read and interpret any forward-looking statements in light of these risks. 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.
Barbara Ryan - Investors
Thomas Gibson - Media
Source: EyePoint Pharmaceuticals, Inc.
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