EyePoint Pharmaceuticals

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Oct 18, 2018

EyePoint Pharmaceuticals Announces Data Highlighting YUTIQ™ to be Presented at the American Academy of Ophthalmology (AAO) 2018 Annual Meeting

- Five oral abstracts to be presented at annual meeting and subspecialty days –
-24-month follow up YUTIQ data to be highlighted at a breakthrough presentation-

WATERTOWN, Mass., Oct. 18, 2018 (GLOBE NEWSWIRE) -- EyePoint Pharmaceuticals (NASDAQ: EYPT), a specialty biopharmaceutical company committed to developing and commercializing innovative ophthalmic products, today announced that five oral abstracts on YUTIQ™ (fluocinolone acetonide intravitreal implant) 0.18 mg, the Company’s three-year micro-insert for chronic non-infectious uveitis affecting the posterior segment of the eye, have been accepted for presentation at the American Academy of Ophthalmology (AAO) 2018 Annual Meeting being held October 27-30, 2018 in Chicago, IL.

“The recent regulatory approval of YUTIQ by the U.S. Food and Drug Administration (FDA) is a significant milestone achieved by the Company and supports our ability to develop and commercialize an innovative treatment solution for the third leading cause of blindness in the U.S.,” said Nancy Lurker, EyePoint’s President and Chief Executive Officer. “We are very pleased that our 24-month Phase 3 clinical data for YUTIQ was accepted as a Late Breaking Developments presentation during the Retina Subspecialty Day in addition to four other oral presentations throughout the meeting. We look forward to continuing our efforts of educating physicians about the benefits of YUTIQ and making this new treatment available to patients suffering from this disease in the first quarter of calendar 2019.”

Details for the AAO presentations are as follows:

  Title: 24-month Evaluation of Fluocinolone Acetonide Intravitreal Insert Treatment for Non-Infectious Posterior Uveitis
Presenter: Quan Nguyen, M.D., M.Sc., Professor of Ophthalmology, Byers Eye Institute, Stanford University School of Medicine
Topic: Late Breaking Developments, Part I, Retina Subspecialty Day 
Date and Time: Friday, October 26, 2018; 4:36 PM CT 
Location: McCormick Place
   
  Title: An Injectable Fluocinolone Implant for Posterior Uveitis: One-Year Results from Two Phase 3 Clinical Trials
Presenter: Glenn Jaffe, M.D., Professor of Ophthalmology, Duke University School of Medicine 
Topic: Innovative Retinal Interventions, Retina Subspecialty Day
Date and Time: Saturday, October 27, 2018; 1:53 PM CT 
Location: McCormick Place
   
  Title: Fluocinolone Acetonide Intravitreal Implant Trial Results
Presenter: Quan Nguyen, M.D., M.Sc., Professor of Ophthalmology, Byers Eye Institute, Stanford University School of Medicine
Topic: Avant-Garde Blues, Uveitis Subspecialty Day
Date and Time: Saturday, October 27, 2018; 4:48 PM CT
Location: McCormick Place
   
  Title: Impact of Baseline Status on Outcomes of Fluocinolone Acetonide Intravitreal Insert for Noninfectious Posterior Uveitis
Presenter: Quan Nguyen, M.D., M.Sc., Professor of Ophthalmology, Byers Eye Institute, Stanford University School of Medicine 
Abstract Number/Publication ID: PA038
Topic: Uveitis, Intraocular Inflammation
Data and Time: Monday, October 29, 2018; 9:18 AM CT 
Location: McCormick Place: Room S405
   
  Title: Fluocinolone Acetonide Intravitreal Insert Treatment for Noninfectious Posterior Uveitis: One-Year Pooled Results
Presenter: Eric Suhler, M.D., M.P.H., Professor of Ophthalmology, Oregon Health & Science University School of Public Health 
Abstract Number/Publication ID: PA040
Topic: Uveitis, Intraocular Inflammation
Date and Time: Monday, October 29, 2018; 9:42 AM CT
Location: McCormick Place: Room S405

About Chronic Non-infectious Uveitis Affecting the Posterior Segment of the Eye

Non-infectious posterior segment uveitis is a chronic, non-infectious inflammatory disease affecting the posterior segment of the eye, often involving the retina, which is believed to be a leading cause of blindness globally. 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 is estimated to affect between 55,000 - 120,000 people resulting in approximately 30,000 cases of blindness, making it the third leading cause of blindness in the U.S. 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, Inc. (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. With the approval of YUTIQTM, the Company has developed four of only five FDA-approved sustained-release treatments for back-of-the-eye diseases. In addition, DEXYCU™ was approved by the FDA on February 9, 2018. DEXYCU, administered as a single intraocular dose at the end of ocular surgery for the treatment of postoperative inflammation, is the first and only FDA-approved intraocular product with this indication. DEXYCU employs the Verisome® extended-release drug delivery technology, which encompasses a broad number of related, but distinct drug delivery systems capable of incorporating an extensive range of active agents, including small molecules, proteins and monoclonal antibodies. ILUVIEN® (fluocinolone acetonide intravitreal implant), a micro-insert for diabetic macular edema, licensed to Alimera Sciences, Inc., 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, Inc.  YUTIQ three-year treatment of chronic non-infectious uveitis affecting the posterior segment of the eye was approved by the FDA on October 12, 2018. The Company's pre-clinical development program is focused on using its core Durasert™ and the Verisome platform technologies to deliver drugs to treat wet age-related macular degeneration, glaucoma, 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 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, plan or believe may occur in the future, including but not limited to statements about our plans to commercialize YUTIQ and DEXYCU, the expected timing of release of the 24-month and 36-month patient follow-up data for YUTIQ and our expectations regarding the timing of a filing of an application for approval of a next-generation, shorter-duration treatment for posterior segment uveitis, 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; our ability to successfully produce commercial supply of YUTIQ and DEXYCU and commercialize YUTIQ and DEXYCU in the U.S.; our ability to successfully build a commercial infrastructure and enter into and maintain commercial agreements for the launch of DEXYCU and YUTIQ; the development of our next-generation YUTIQ short-acting treatment for uveitis;  potential off-label sales of ILUVIEN for non-infectious posterior segment uveitis (“NIPU”); consequences of fluocinolone acetonide side effects; successful commercialization of, and receipt of revenues from, ILUVIEN for diabetic macular edema (“DME”) which depends on the ability of Alimera Sciences, Inc. (“Alimera”) to continue as a going concern; Alimera’s ability to obtain additional marketing approvals and the effect of pricing and reimbursement decisions on sales of ILUVIEN for DME; Alimera’s ability to obtain marketing approval for ILUVIEN in its licensed territories for NIPU; potential declines in Retisert royalties; 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, contract sales 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 exit of the United Kingdom from the European Union; 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.

Contacts

Investors:
Argot Partners
Kimberly Minarovich
(646) 368-8014
kimberly@argotpartners.com

Joseph Rayne
(617) 340-6075
joseph@argotpartners.com

Media:
Thomas Gibson
201-476-0322
tom@tomgibsoncommunications.com

 

 

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Source: EyePoint Pharmaceuticals, Inc.

EyePoint Pharmaceuticals