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EyePoint Pharmaceuticals Reports Fiscal First Quarter 2019 Financial Results and
Highlights Recent Clinical and Operational Developments
-YUTIQ approved by U.S. FDA; anticipated launch in calendar 1Q19-
-Exclusive license granted to Ocumension Therapeutics to develop and commercialize EyePoints three-year micro-insert product using the Durasert technology for posterior segment uveitis in Greater China-
-Commercial preparations underway for anticipated launch of DEXYCU in the first half of calendar year 2019-
-Cash injection of $28.9 million from warrant exercise-
-Conference call and webcast today, November 6th, at 8:00 AM ET-
WATERTOWN, Mass., November 6, 2018 (GLOBE NEWSWIRE) EyePoint Pharmaceuticals, Inc. (NASDAQ: EYPT), a specialty biopharmaceutical company committed to developing and commercializing innovative ophthalmic products, today reported operating and financial results for its fiscal 2019 first quarter ended September 30, 2018 and highlighted recent clinical and operational developments.
The approval of YUTIQ by the U.S. FDA in October marked a significant achievement for EyePoint and validates the Companys innovation and ability to develop an effective treatment to decrease recurrence of uveitic flares from non-infectious posterior segment uveitis that can result in blindness, said Nancy Lurker, President and Chief Executive Officer of EyePoint Pharmaceuticals. Following the positive reception by retina and uveitis specialists of the clinical data presented for YUTIQ at the American Academy of Ophthalmology 2018 Annual Meeting, we believe that we are well-positioned for a successful product launch planned in the first quarter of calendar 2019. In addition, we are scaling up our manufacturing of DEXYCU ahead of an anticipated launch in the first half of calendar 2019.
Recent Clinical & Operational Highlights
In October 2018, the U.S. Food and Drug Administration (FDA) approved YUTIQ (fluocinolone acetonide intravitreal implant) 0.18 mg, a three-year micro-insert for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye. YUTIQ utilizes the Companys Durasert drug delivery technology and is an intravitreal micro-insert designed to deliver drug consistently over 36 months. The approval occurred 24 days in advance of the PDUFA date of November 5th.
The following information was filed by Eyepoint Pharmaceuticals, Inc. (EYPT) on Tuesday, November 6, 2018 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-Q Quarterly Report statement of earnings and operation as management may choose to highlight particular information in the press release.
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