EyePoint Pharmaceuticals and Harrow Health’s ImprimisRx Announce U.S. Commercial Alliance for DEXYCU®
DEXYCU will be marketed as a top priority program within our commercial organization and our initial focus will be on accounts currently purchasing Tri-Moxi.
WATERTOWN, Mass. and NASHVILLE, Tenn., Aug. 04, 2020 (GLOBE NEWSWIRE) -- EyePoint Pharmaceuticals, Inc. (NASDAQ: EYPT), a pharmaceutical company committed to developing and commercializing innovative ophthalmic products, and ImprimisRx, the nation’s leading ophthalmic-focused outsourcing facility and pharmaceutical compounding business and a wholly-owned subsidiary of Harrow Health, Inc. (NASDAQ: HROW), today announced the signing of a commercial alliance for the joint promotion of DEXYCU® (dexamethasone intraocular suspension) 9% for the treatment of post-operative inflammation following ocular surgery in the U.S.
“EyePoint is excited to collaborate with the ImprimisRx team to expand the commercial reach of DEXYCU to cataract surgeons and patients in need of more effective treatments to manage ocular inflammation following surgery,” said Nancy Lurker, President and Chief Executive Officer of EyePoint Pharmaceuticals. “Through this agreement, we are able to access the established and complementary ImprimisRx commercial operations in cataract surgery to include DEXYCU as a prioritized product in its existing portfolio of product offerings. The combination of the EyePoint sales and marketing team with the depth of ImprimisRx in the cataract surgery space, positions DEXYCU for accelerated growth bringing its many benefits to more physicians and patients.”
“We are thrilled to add the first and only FDA-approved intracameral injectable steroid product to our portfolio of surgical formulations, which will help us address unmet medical needs in the ocular surgery market,” said John Saharek, President of ImprimisRx. “Based on the conversations we’ve have had with our customers, there is strong demand and preference for FDA-approved products, which gives me confidence that our customers will embrace the option of using DEXYCU. DEXYCU will be marketed as a top priority program within our commercial organization and our initial focus will be on accounts currently purchasing Tri-Moxi®. Having sold over 250,000 ophthalmic injectable units used during cataract surgery in 2019 to our loyal customer base, the choice to use DEXYCU, an innovative FDA-approved injectable steroid product with a specific and permanent reimbursement J-code, will give hundreds of our surgical customers a new tool to improve the health outcomes of their patients. We look forward to working in collaboration with the EyePoint team to greatly enhance the level of commercial success of DEXYCU and build customer demand in this attractive and growing market.”
Under the terms of the commercial alliance, ImprimisRx will deploy its sales specialists and their inside sales team to promote DEXYCU to ophthalmologist, hospital, and ambulatory surgical center (ASC) customers beginning immediately. ImprimisRx will initially focus on accounts currently purchasing Tri-Moxi and will be prioritizing its Tri-Moxi resources to support DEXYCU moving forward. EyePoint will be responsible for the marketing, selling, pricing, manufacturing, and contracting for DEXYCU while also seeking additional volume-based agreements with ASCs and integrated health care networks to expand patient access. ImprimisRx will be entitled to receive a commission on the incremental sales that exceed pre-specified volume targets. EyePoint will retain all commercial rights for DEXYCU outside of the U.S.
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 intraocular drug delivery including EYP-1901, a potential six month VEGF inhibitor initially targeting wet age-related macular degeneration. 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.
About Harrow Health
Harrow Health, Inc. (NASDAQ: HROW) owns a portfolio of healthcare businesses, including ImprimisRx, the nation’s leading ophthalmology outsourcing facility and pharmaceutical compounding business. The company holds large equity positions in Eton Pharmaceuticals, Surface Pharmaceuticals, and Melt Pharmaceuticals. Harrow also owns Mayfield Pharmaceuticals, Stowe Pharmaceuticals, and Visionology, all companies founded as subsidiaries of Harrow Health. The Company also owns royalty rights in certain drug candidates being developed by Surface, Melt, and Mayfield. Harrow intends to create, invest in and grow paradigm shifting healthcare businesses that put patients first. For more information about Harrow Health, please visit the Investor Relations section of the corporate website by clicking here.
About ImprimisRx
ImprimisRx is the nation’s leading ophthalmology-focused outsourcing facility and pharmaceutical compounding business, serving thousands of ophthalmologists and optometrists in all 50 states, with 40 proprietary ophthalmic formulations. ImprimisRx is headquartered in San Diego, CA and owns two FDA-inspected production and dispensing facilities in Ledgewood, New Jersey. There have been over three million eyes served by the formulations produced at these facilities. For more information about ImprimisRx, including ordering instructions, please visit our website, www.imprimisrx.com/.
EyePoint Forward-Looking Statements
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.
Harrow Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this release that are not historical facts may be considered such "forward-looking statements." Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties which may cause results to differ materially and adversely from the statements contained herein. Some of the potential risks and uncertainties that could cause actual results to differ from those predicted include our ability to make commercially available our compounded formulations and technologies in a timely manner or at all; physician interest in prescribing our formulations; risks related to our compounding pharmacy operations; our ability to enter into other strategic alliances, including arrangements with pharmacies, physicians and healthcare organizations for the development and distribution of our formulations; our ability to obtain intellectual property protection for our assets; our ability to accurately estimate our expenses and cash burn, and raise additional funds when necessary; risks related to research and development activities; the projected size of the potential market for our technologies and formulations; unexpected new data, safety and technical issues; regulatory and market developments impacting compounding pharmacies, outsourcing facilities and the pharmaceutical industry; competition; and market conditions. These and additional risks and uncertainties are more fully described in Harrow Health’s filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Such documents may be read free of charge on the SEC’s web site at www.sec.gov. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made. Except as required by law, Harrow Health undertakes no obligation to update any forward-looking statements to reflect new information, events or circumstances after the date they are made, or to reflect the occurrence of unanticipated events.
EyePoint Contacts:
Investors:
Argot Partners
Sam Martin or Joe Rayne
212-600-1902
[email protected]
Media:
Thomas Gibson
201-476-0322
[email protected]
Harrow Contacts:
Investors:
Andrew Boll
[email protected]
615-733-4731
Media:
Deb Holliday
Holliday Communications, Inc.
[email protected]
412.877.4519
