WATERTOWN, Mass., May 18, 2020 (GLOBE NEWSWIRE) — EyePoint Pharmaceuticals, Inc. (NASDAQ: EYPT), a pharmaceutical company committed to developing and commercializing innovative ophthalmic products, today announced the presentation of positive retrospective case study data supporting DEXYCU® (dexamethasone intraocular suspension) 9% for the treatment of post-operative inflammation following ocular surgery. The data were presented in three electronic posters and one oral paper session at the American Society of Cataract and Refractive Surgery (ASCRS) 2020 Virtual Annual Meeting on May 16-17, 2020.
The ongoing retrospective study is designed to provide large-scale, real-world data from surgeons based on their early experiences with DEXYCU. The study is expected to enroll up to 600 patients at approximately 40 study sites. Each time point of data in the real-world study reflects patient chart data and frequency of measurement by participating physicians.“Preliminary results from the retrospective case review of real-world use of DEXYCU have re-confirmed the strong, early-acting anti-inflammatory activity of DEXYCU seen in clinical studies,” said Nancy Lurker, President and Chief Executive Officer of EyePoint Pharmaceuticals. “We are pleased with the ambulatory surgical center adoption seen to date and the positive reception around DEXYCU’s advantages compared to the burdensome steroid eye drop regimen. We are also encouraged by trends showing the re-opening of centers in areas where COVID-19 pandemic restrictions have been lifted, and we believe that DEXYCU may reduce the frequency of in-person physician follow-up visits and limit physician and caregiver contact with the patient’s face and eyes. The retrospective case study data provide additional validation of our belief that DEXYCU can improve patient compliance for this growing ocular unmet need.”DEXYCU administration technique was also featured during the ASCRS Scientific Film session in a video by Michael A. Saidel, M.D., Corneal Specialist and Comprehensive Ophthalmologist, North Bay Eye Associates, entitled, “Evolution of an Administration Technique for Dexamethasone Intraocular Suspension 9%.”Summaries of the ASCRS presentations are as follows:Paper Session Title: Retrospective Case Study Data on Dexamethasone Intraocular Suspension 9% for Inflammation Control after Cataract Surgery
Presenter: Robert J. Weinstock, M.D., Director of Cataract and Refractive Surgery, The Eye Institute of West Florida and the Weinstock Laser Eye Center
Session Title: Cataract Surgery – MedicationsInterim results presented were from 31 patients administered DEXYCU from Dr. Weinstock’s practice. The proportion of patients with complete anterior chamber cell clearing (cell score=0), a measurement of inflammation, was 45.2%, 90.0%, 90.0% and 100.0% at postoperative day 1, 8, 14 and 30, respectively. The proportion of patients with no anterior chamber flares (flare score=0), another measurement of inflammation, was 87.1%, 100.0%, 100.0% and 100.0% at postoperative day 1, 8, 14 and 30, respectively. Mean intraocular pressure at postoperative day 1 was 17.4 mmHg, with levels decreasing through to postoperative day 30. Title: Real-World Efficacy of Dexamethasone Intraocular Suspension 9%: Data from a Retrospective Case Study
Presenter: Cynthia Matossian, M.D., Founder and Chief Executive Officer, Matossian Eye AssociatesInterim results presented were from 271 patients administered DEXYCU with average age of 72. The proportion of eyes with complete anterior chamber cell clearing (cell score=0), a measurement of inflammation, was 51.2%, 60.9%, 86.2% and 90.5% at postoperative day 1, 8, 14 and 30, respectively. The proportion of patients with no anterior chamber flares (flare score=0), another measurement of inflammation, was 85.9%, 97.1%, 99.1% and 99.1% at postoperative day 1, 8, 14 and 30, respectively. Mean intraocular pressure at postoperative day 1 was 18.4 mmHg, with levels decreasing through to postoperative day 30. Poster Title: Analysis of Performance and Best Practices with Dexamethasone Intraocular Suspension 9%: Data from a Retrospective Case Study
Presenter: Cynthia Matossian, M.D., Founder and Chief Executive Officer, Matossian Eye AssociatesInterim results presented were from 25 patients administered DEXYCU from Dr. Matossian’s practice. The proportion of eyes with complete anterior chamber cell clearing (cell score=0), a measurement of inflammation, was 71.4%, 64.7%, 66.7% and 100.0% at postoperative day 1, 8, 14 and 30, respectively. The proportion of patients with no anterior chamber flares (flare score=0), another measurement of inflammation, was 97.1%, 100.0%, 100.0% and 100.0% at postoperative day 1, 8, 14 and 30, respectively. Mean intraocular pressure at postoperative day 1 was 19.4 mmHg, with levels decreasing through to postoperative day 30. DEXYCU was well tolerated.Poster Title: Surgeon and Patient Satisfaction with Sustained-Release Dexamethasone Intraocular Suspension 9% for Post-Cataract Inflammation Control
Presenter: Cathleen McCabe, M.D., Cataract and LASIK Surgeon, The Eye AssociatesSurgeons participating in the retrospective study were asked a series of questions related to their experience using DEXYCU. In 91.3% of cases, surgeons were “very satisfied” or “satisfied” with their use of DEXYCU on a per-patient basis. In 93.6% of cases, surgeons were
“very satisfied” or “satisfied” with the ease of use of DEXYCU on a per-patient basis. 79.0% of surgeons believed the efficacy of DEXYCU was superior to topical steroids. In 90.6% of cases, patients were “very satisfied” or “satisfied” with their use of DEXYCU according to surgeon reports. About DEXYCU®
DEXYCU® (dexamethasone intraocular suspension) 9% is indicated for the treatment of postoperative inflammation and was approved by the FDA on February 9, 2018. A link to the full product label is available at: https://dexycu.com/wp-content/uploads/2019/01/DEXYCU-PI-20181220.pdf.About EyePoint Pharmaceuticals
EyePoint Pharmaceuticals, Inc. (www.eyepointpharma.com) is a pharmaceutical 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 currently has two commercial products: DEXYCU®, the first approved intraocular product for the treatment of postoperative inflammation, and YUTIQ®, a three-year treatment of chronic non-infectious uveitis affecting the posterior segment of the eye. The Company’s pipeline leverages its proprietary bioerodible Durasert® technology for extended intravitreal drug delivery including EYP-1901, a VEGF inhibitor, targeting wet age-related macular degeneration, diabetic retinopathy and retinal vein occlusion. EyePoint Pharmaceuticals is headquartered in Watertown, Massachusetts with offices in Basking Ridge, New Jersey. 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: 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 expectations regarding the extent to which our business could be adversely impacted by the effects of the COVID-19 coronavirus pandemic, as well as the timing and clinical development of our product candidates, including EYP-1901; and the potential for EYP-1901 as a vital, novel six-month treatment for serious eye diseases, including wet age-related macular degeneration, diabetic retinopathy and retinal vein occlusion. 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 are risks and uncertainties inherent in our business including, without limitation: the extent to which COVID-19 impacts our business; 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; potential off-label sales of ILUVIEN for non-infectious uveitis affecting the posterior segment of the eye; consequences of fluocinolone acetonide side effects for YUTIQ; consequences of dexamethasone side effects for DEXYCU; successful commercialization of, and receipt of revenues from, ILUVIEN for diabetic macular edema, or DME; 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 commercialize ILUVIEN for non-infectious uveitis affecting the posterior segment of the eye in the territories in which Alimera is licensed to do so; our ability to market and sell products; the success of current and future license agreements, including our agreement with Equinox Science; termination or breach of current license agreements, including our agreement with Equinox Science; 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; 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.Contacts
Investors:
Argot Partners
Sam Martin or Joe Rayne
212-600-1902
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Thomas Gibson
201-476-0322
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