Full Press Release Details
EyePoint Pharmaceuticals Provides 2019 Commercial Update
- DEXYCUTM commercial launch now expected in 1Q19, earlier than prior guidance of 1H19
- YUTIQTM commercial launch on track for 1Q19 -
WATERTOWN, Mass., January 3, 2019 EyePoint Pharmaceuticals (NASDAQ: EYPT), a specialty biopharmaceutical company committed to developing
and commercializing innovative ophthalmic products, today provided a 2019 commercial update.
EyePoint has made significant progress in
building its commercial infrastructure in preparation for two ophthalmic product launches in the near-term, said Nancy Lurker, President and Chief Executive Officer of EyePoint Pharmaceuticals. As a result of the diligence with which our
team has worked to execute on commercial manufacturing scale-up, communicate with payors, build our distribution network and our hub for patient and physician support, I am pleased to be able to announce that
along with the launch of YUTIQTM in the first quarter of calendar 2019, we also now anticipate launching DEXYCUTM in the first quarter of
calendar 2019, earlier than initially expected. We are excited to be able to commercialize both of these innovative ocular products and we look forward to making a meaningful difference in the established treatment paradigms for cataract surgery and
posterior uveitis, which are both areas of high unmet medical need.
Key Commercial Updates
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 by the FDA on October 12, 2018 of
YUTIQ three-year treatment of chronic non-infectious uveitis affecting the posterior segment of the eye, the Company has developed five of the six FDA-approved
sustained-release treatments for eye diseases. The most common adverse reactions reported for YUTIQ were cataract development and increases in intraocular pressure. 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. The most common adverse
reactions reported by 5-15% of patients were intraocular pressure increased, corneal edema and iritis. DEXYCU employs the Verisome extended-release
drug delivery technology, which encompasses a broad number of related, but distinct drug delivery systems with the potential 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. 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.