WATERTOWN, Mass., July 27, 2020 (GLOBE NEWSWIRE) -- EyePoint Pharmaceuticals, Inc. (NASDAQ: EYPT), a pharmaceutical company committed to developing and commercializing innovative ophthalmic products, today announced the presentation of data supporting YUTIQ® (fluocinolone acetonide intravitreal implant) 0.18 mg three-year micro-insert for chronic, non-infectious uveitis affecting the posterior segment of the eye. The data were presented in two oral sessions at the American Society of Retina Specialists (ASRS) Virtual Annual Meeting held July 24 – 26, 2020.
“These supportive results continue to build on the strong product profile of YUTIQ, which provides sustained and long-lasting anti-inflammatory activity for up to 36 months for this difficult to treat ocular disease,” said Nancy Lurker, President and Chief Executive Officer of EyePoint Pharmaceuticals. “These key product features have been particularly valuable during the global COVID-19 pandemic as they may reduce the need for patient visits and limit a physician’s interaction with a patient’s face and eyes. We look forward to continuing to advance this innovative therapy within the greater ocular disease community on behalf of patients in need.”
Data included in the two presentations at ASRS are from the first double-masked, randomized Phase 3 trial of YUTIQ, which enrolled 129 patients in 16 centers in the U.S. and 17 centers outside the U.S. 87 eyes were treated with YUTIQ and 42 eyes received sham injections.
Summaries of the ASRS presentations are as follows:
Title: Evaluating the True Rate of Recurrence of Non-Infectious Posterior Segment Uveitis Following Treatment with an Injectable Fluocinolone Acetonide Insert (FAi)
Presenter: Dilraj Grewal, M.D., Associate Professor of Ophthalmology, Duke Eye Center
Session Title: Inflammatory and Infectious Diseases Symposium
A post-hoc analysis of the Phase 3 results examined imputed recurrences driven by the use of confounding systemic medications to determine the true recurrence rate for YUTIQ and sham eyes through 36 months. There were 10 patients in the YUTIQ arm that received systemic treatment due to fellow eye or for non-ocular conditions. 48% of YUTIQ eyes had a reported imputed recurrence of which 40% were due to adjunctive medicine use, 31% from systemic treatments and 9% from local injections. 71% of sham eyes had a reported imputed recurrence, of which 64% were due to adjunctive medicine use, 21% from systemic treatments and 43% from local injections. Over half of the recurrences were imputed as a result of a confounding systemic medication use, which suggests the recurrence rate of YUTIQ is likely lower than 56% as reported in the primary analysis.
Title: Course of Macular Edema Through 36 Months With Fluocinolone Acetonide Intravitreal Insert for Non-infectious Uveitis Affecting the Posterior Segment,
Presenter: Seenu M. Hariprasad, M.D., Shui-Chin Lee Professor Of Ophthalmology, University of Chicago
Session Title: Inflammatory and Infectious Diseases Symposium
At 36-months, rates of macular edema, as determined by investigator clinical interpretation, were reduced by 48% from baseline for YUTIQ eyes compared to 41% for sham eyes despite a greater proportion of sham patients receiving local or systemic medications. In patients with macular edema at baseline, the proportion of eyes gaining 3 or more lines of vision was higher for YUTIQ eyes compared to sham eyes (50% vs 22%). The proportion of eyes losing 3 or more lines of vision was higher for sham eyes compared to YUTIQ eyes (9% vs 0%). These results demonstrated YUTIQ increased the resolution of macular edema and improved visual acuity, key components of treating chronic, non-infectious uveitis affecting the posterior segment of the eye.
YUTIQ® (fluocinolone acetonide intravitreal implant) 0.18 mg is indicated for the treatment of chronic, non-infectious uveitis affecting the posterior segment of the eye, and was approved by the FDA on October 12, 2018. A link to the full product label is available on the EyePoint Pharma website at: www.eyepointpharma.com/wp-content/uploads/2019/01/YUTIQ-USPI-20181120.pdf.
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 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 either local steroid injections, with limited duration of effect, or 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. (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.
Sam Martin or Joe Rayne
Source: EyePoint Pharmaceuticals, Inc.