Eric D. Donnenfeld, MD of OCLI, Ophthalmic Consultants of Connecticut (“OCC”), Spectrum Vision Partners (“SVP”) managed practices, often sought for his expertise and innovation in the field of Ophthalmology, has successfully performed the first Cataract Surgery in the United States, utilizing FDA approved DEXYCU™ (dexamethasone intraocular suspension) 9%, at Island Eye Surgicenter in Westbury, NY. EyePoint Pharmaceuticals, Inc. is a specialty biopharmaceutical company committed to developing and commercializing innovative ophthalmic products, announced yesterday that it has commercially launched DEXYCU™ (dexamethasone intraocular suspension) 9% in the United States. DEXYCU is the first and only U.S. Food and Drug Administration (FDA) approved intraocular steroid for the treatment of postoperative inflammation and is administered as a single dose at the end of cataract surgery. DEXYCU is intended to replace the use of steroid eye drops which have a dosing regimen that, depending on the brand, can require self-administration for up to four times a day and titrating down over four weeks. This complicated dosing regimen can often lead to poor patient compliance.
Dr. Donnenfeld expresses his support of innovation to enhance patient outcome, “Today was an important day for Ophthalmology. The FDA approval of DEXYCU allows patients having cataract surgery to have their medication placed inside their eye. This improves patient compliance, quality of life and is the first step in eliminating eye drops in cataract surgery.”
The launch of DEXYCU will be phased, with the initial phase being to leading cataract surgery experts such as Dr. Donnenfeld, to ensure proper training on DEXYCU’s administration ahead of its wider availability in the ophthalmology community. EyePoint Assist, the Company-sponsored program designed to ensure access to DEXYCU, is available for eligible patients in need of financial assistance.
Tom Burke, CEO of Spectrum Vision Partners commented on today’s news, “Spectrum Vision Partners is proud to continue its collaboration with national leaders who bring the latest innovations in advanced cataract surgery to their patients. Dr. Donnenfeld, the OCLI vision experts and the Island Eye Surgicenter team have delivered another advancement to improve visual outcomes and their patients’ lives. Performing the first FDA approved DEXYCU drug delivery in the United States is another example of their leadership in the ophthalmic field. We applaud the success of Eye Point Pharmaceuticals with this application of their delivery system and look forward to continuing SVP’s collaboration with our doctors as they continue to improve patient care.”
“EyePoint is proud to announce the U.S. commercial launch of our second innovative ophthalmic product, DEXYCU, which is now available to cataract surgery patients to treat inflammation that occurs after this common surgical procedure. There are approximately 4.8 million cataract surgeries a year in the US,” said Nancy Lurker, President and Chief Executive Officer of EyePoint Pharmaceuticals. “DEXYCU offers a single-dose, sustained release treatment option conveniently administered at the end of cataract surgery which can eliminate the complicated and burdensome steroid eyedrop regimen following surgery.”
DEXYCU is the first long-acting intraocular steroid approved by the FDA for the treatment of postoperative inflammation. Cataract surgery is the most frequent surgical procedure in the U.S., with approximately 4.8 million performed annually. DEXYCU employs the Company’s Verisome sustained-release drug delivery technology to deliver a biodegradable extended-release formulation of the steroid dexamethasone into the posterior chamber of the eye via a single injection at the end of surgery, eliminating the burden of self-administering steroid eye drops up to four times a day for several weeks on a titrated schedule, in a primarily elderly patient population.
Learn more about Eric Donnenfeld, MD
Learn more about Spectrum Vision Partners
Learn more about OCLI
Learn more about OCC
Learn more about Island Eye Surgicenter
Learn more about DEXYCU™
Learn more about EyePoint Pharmaceuticals
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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 commercialization of 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 successful release of our YUTIQ line extension shorter-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.