WATERTOWN, Mass. and BEIJING, June 21, 2022 (GLOBE NEWSWIRE) — EyePoint Prescription drugs, Inc. (NASDAQ: EYPT), a pharmaceutical firm dedicated to growing and commercializing therapeutics to assist enhance the lives of sufferers with critical eye issues, and OcuMension Therapeutics (HKSE: 1477), a fast-growing ophthalmology targeted pharmaceutical firm in China, as we speak introduced that China’s Middle for Drug Analysis (CDE) of the Nationwide Medical Merchandise Administration (NMPA) has accepted YUTIQ® (fluocinolone acetonide intravitreal implant) 0.18mg for the remedy of power non-infectious uveitis affecting the posterior section of the attention. YUTIQ is the primary drug accepted for commercialization in China based mostly solely on real-world information, in addition to the primary drug accepted for industrial use in OcuMension’s modern pipeline.
In September 2020, OcuMension launched a real-world research of YUTIQ for the remedy of power, non-infectious uveitis affecting the posterior section of the attention at Boao Lecheng Tremendous Hospital in Hainan Province by way of the pressing medical want channel granted to Boao Lecheng Pilot Zone. In April 2021, the CDE accepted OcuMension’s new drug utility (NDA) for YUTIQ that was filed with the real-world information collected at Boao Lecheng Tremendous Hospital.
“YUTIQ’s approval in China marks an vital milestone for EyePoint and OcuMension’s shared mission of bringing sustained-release drug supply therapies to sufferers with debilitating illnesses of the attention,” mentioned Nancy Lurker, Chief Govt Officer of EyePoint Prescription drugs. “Since YUTIQ’s U.S. approval over three years in the past, EyePoint has been capable of ship this modern ocular remedy and supply an improved normal of look after sufferers by offering as much as three years of steady management in power, non-infectious uveitis affecting the posterior section of the attention. We’re proud to associate with OcuMension and increase YUTIQ’s international attain within the rising Chinese language market as we work collectively to enhance the lives of sufferers with critical eye issues.”
“We’re thrilled to announce the brand new drug approval for YUTIQ in China. This approval marks the first-ever remedy accepted from OcuMension’s modern pipeline and, extra importantly, a vital therapeutic development for sufferers affected by power, non-infectious uveitis affecting the posterior section of the attention,” mentioned Ye Liu, Chief Govt Officer of OcuMension Therapeutics. “The OcuMension group has been working diligently to deliver this potential best-in-class drug to Chinese language sufferers as quickly as doable, and I want to specific my sincerest gratitude to all of our colleagues in R&D, registration and commercialization that contributed diligently to YUTIQ’s approval. We might additionally prefer to thank Boao Lecheng Tremendous Hospital for serving to us execute the real-world research of YUTIQ and our companions at EyePoint for his or her help on this registration and utility. We’re dedicated to bringing YUTIQ to market as quickly as doable to profit Chinese language sufferers in want.”
YUTIQ obtained approval by the U.S. Meals and Drug Administration (FDA) on October 18, 2018. The remedy is at present marketed by EyePoint within the U.S., and EyePoint maintains growth and commercialization rights for YUTIQ for the remedy of non-infectious uveitis affecting the posterior section of the attention within the Americas and in Asia.
About Non-Infectious Uveitis Affecting the Posterior Phase of the Eye
Non-infectious uveitis affecting the posterior section of the attention is a power type of uveitis which will trigger quite a lot of issues, together with cataracts and glaucoma. When the irritation isn’t managed in a well timed method, it might probably result in visible impairment and even everlasting imaginative and prescient loss. The advanced medical presentation of non-infectious uveitis and the excessive diploma of similarity between subtypes pose a major problem for correct prognosis. There are 1.4 million sufferers with this situation in China.
YUTIQ® (fluocinolone acetonide intravitreal implant) 0.18 mg is indicated for the remedy of power, non-infectious uveitis affecting the posterior section of the attention, and was accepted by the FDA on October 12, 2018. A hyperlink to the complete product label is offered on the YUTIQ web site at: https://yutiq.com/downloads/US-YUT-2100035percent20YUTIQpercent20Prescribingpercent20Information-2021.pdf.
About EyePoint Prescription drugs
EyePoint Prescription drugs (Nasdaq: EYPT) is a pharmaceutical firm dedicated to growing and commercializing therapeutics to assist enhance the lives of sufferers with critical eye issues. The Firm’s pipeline leverages its proprietary Durasert® expertise for sustained intraocular drug supply together with EYP-1901, an investigational sustained supply intravitreal anti-VEGF remedy initially concentrating on moist age-related macular degeneration. The confirmed Durasert drug supply platform has been safely administered to hundreds of sufferers’ eyes throughout 4 U.S. FDA accepted merchandise, together with YUTIQ® for the remedy of power non-infectious uveitis affecting the posterior section of the attention, which is at present marketed by the Firm. EyePoint Prescription drugs is headquartered in Watertown, Massachusetts.
OcuMension is a China-based ophthalmic pharmaceutical platform firm devoted to figuring out, growing and commercializing first- or best-in-class ophthalmic therapies. Its imaginative and prescient is to offer a world-class pharmaceutical complete resolution to deal with important unmet ophthalmic medical wants in China. We imagine that our ophthalmic pharmaceutical platform with a transparent first-mover benefit will safe us a number one place within the ophthalmic business in China. So far, the Firm has 22 drug belongings within the instant and posterior segments of the attention, establishing a complete ophthalmic drug pipeline, of which six merchandise have entered Part III medical trials. The NDA for OT-401 (fluocinolone acetonide intravitreal implant), our core product, has been accepted by the CDE, and is the primary new drug utilized for NDA in China based mostly solely on actual world information. On 10 July 2020, OcuMension Therapeutics was listed on the Important Board of The Inventory Alternate of Hong Kong Restricted (inventory code: 01477). For extra info on OcuMension Therapeutics, please go to https://www.ocumension.com/.
EYEPOINT PHARMACEUTICALS SAFE HARBOR STATEMENTS UNDER THE PRIVATE SECURITIES LITIGATION ACT OF 1995: To the extent any statements made on this press launch take care of info that’s not historic, these are forward-looking statements below the Personal Securities Litigation Reform Act of 1995. Such statements embrace, however will not be restricted to, statements relating to using proceeds for the providing and different statements recognized by phrases similar to “will,” “potential,” “may,” “can,” “imagine,” “intends,” “proceed,” “plans,” “expects,” “anticipates,” “estimates,” “could,” different phrases of comparable that means or using future dates. Ahead-looking statements by their nature handle issues which might be, to totally different levels, unsure. Uncertainties and dangers could trigger EyePoint’s precise outcomes to be materially totally different than these expressed in or implied by EyePoint’s forward-looking statements. For EyePoint, this consists of uncertainties relating to the timing and medical growth of our product candidates, together with EYP-1901; the potential for EYP-1901 as a novel six-month remedy for critical eye illnesses, together with moist age-related macular degeneration; the effectiveness and timeliness of medical trials, and the usefulness of the information; the timeliness of regulatory approvals; the success of present and future license agreements; our dependence on contract analysis organizations, co-promotion companions, and different outdoors distributors and repair suppliers; results of competitors and different developments affecting gross sales of our commercialized merchandise, YUTIQ® and DEXYCU®; market acceptance of our merchandise; product legal responsibility; business consolidation; compliance with environmental legal guidelines; dangers and prices of worldwide enterprise operations; volatility of inventory worth; doable dilution; absence of dividends; the continued influence of the COVID-19 pandemic on EyePoint’s enterprise, the medical neighborhood and the worldwide financial system, and the influence of common enterprise and financial situations. Extra detailed info on these and extra elements that would have an effect on EyePoint’s precise outcomes are described in EyePoint’s filings with the SEC, together with its Annual Report on Type 10-Okay for the fiscal 12 months ended December 31, 2020, as revised or supplemented by its Quarterly Stories on Type 10-Q and different paperwork filed with the SEC. All forward-looking statements on this information launch converse solely as of the date of this information launch. EyePoint undertakes no obligation to replace or revise any forward-looking assertion, whether or not because of new info, future occasions or in any other case.
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