EyePoint Pharmaceuticals Receives Preliminary Extension to Pass-Through Payment Status for DEXYCU®

Rhea-AI Summary

EyePoint Pharmaceuticals (NASDAQ: EYPT) announced a nine-month extension of DEXYCU®'s pass-through payment status following a draft ruling by the Centers for Medicare and Medicaid Services (CMS). This extension, set to last until December 31, 2022, aids in the coverage of outpatient drugs during cataract surgeries, impacting approximately 60% of Medicare Part B patients. The final ruling from CMS is expected in November 2021. CEO Nancy Lurker expressed optimism about the extension, emphasizing its significance for DEXYCU's commercial strategy.

Positive

• Nine-month extension of DEXYCU's pass-through payment status until December 31, 2022.
• Extension supports coverage for approximately 60% of patients undergoing cataract surgery.

Negative

• None.

WATERTOWN, Mass., July 20, 2021 (GLOBE NEWSWIRE) -- EyePoint Pharmaceuticals, Inc. (NASDAQ: EYPT), a pharmaceutical company committed to developing and commercializing therapeutics to help improve the lives of patients with serious eye disorders, announced today that the Company expects to receive a nine month extension on DEXYCU^®’s pass-through payment status, which otherwise would expire on March 31, 2022.

On July 19, 2021, The Centers for Medicare and Medicaid Services (CMS) released its 2022 draft Hospital Outpatient Prospective Payment System (HOPPS) rule, which indicates that CMS plans to extend the pass-through period for select outpatient drugs and device products, such as DEXYCU, due to the public health emergency associated with the COVID-19 pandemic. The draft rules are subject to a public comment period prior to the issuance by CMS of the final 2022 HOPPS rule, which is anticipated in November 2021.

“We are extremely pleased that the CMS has indicated it intends to provide additional pass-through time, subject to public comment, allowing for another nine months of pass through status for important innovative products such as DEXYCU,” said Nancy Lurker, Chief Executive Officer of EyePoint Pharmaceuticals. “The continuation of pass-through status by the CMS is an important step as we continue to execute on our commercial strategy of expanding the use of DEXYCU by physicians for their patients.”

Approximately 60% of patients who undergo cataract surgery are covered by Medicare Part B. Drugs that are administered as part of the cataract surgery procedure can be covered under a CMS administered transitional-pass-through payment. The pass-through payment was established by the U.S. government to help foster innovative drug development. Drug applications must meet certain qualifications for inclusion. The transitional pass-through status is typically three years.

About EyePoint Pharmaceuticals, Inc. (Nasdaq:EYPT) is a pharmaceutical company committed to developing and commercializing therapeutics to help improve the lives of patients with serious eye disorders. The Company’s pipeline leverages its proprietary Durasert^® technology for sustained intraocular drug delivery including EYP-1901, a potential twice-yearly intravitreal anti-VEGF treatment initially targeting wet age-related macular degeneration. The Company has two commercial products: YUTIQ^®, for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye, and DEXYCU^®, for the treatment of postoperative inflammation following ocular surgery. EyePoint Pharmaceuticals is headquartered in Watertown, Massachusetts. 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: To the extent any statements made in this press release deal with information that is not historical, these are forward-looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements regarding the anticipated use of proceeds for the proposed offering and other statements identified by words such as “will,” “potential,” “could,” “can,” “believe,” “intends,” “continue,” “plans,” “expects,” “anticipates,” “estimates,” “may,” other words of similar meaning or the use of future dates. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause EyePoint’s actual results to be materially different than those expressed in or implied by EyePoint’s forward-looking statements. For EyePoint, this includes the continued impact of the COVID-19 pandemic on EyePoint’s business, the medical community and the global economy and the impact of general business and economic conditions, our expectations regarding the timing and clinical development of our product candidates, including EYP-1901; and the potential for EYP-1901 as a novel twice-yearly treatment for serious eye diseases, including wet age-related macular degeneration, diabetic retinopathy and retinal vein occlusion; 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; the success of current and future license agreements, including our agreements with Ocumension Therapeutics and Equinox Science; termination or breach of current license agreements, including our agreements with Ocumension Therapeutics and Equinox Science; our dependence on contract research organizations, co-promotion partners, and other outside vendors and service providers; 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.

Investors:

Christina Tartaglia
Stern IR
Direct: 212-698-8700
christina.tartaglia@sternir.com

Media Contact

Green Room Public Relations
Caren Begun
Green Room Communications
Direct: (201) 396-8551 
caren@greenroompr.com   

FAQ

What is the significance of the DEXYCU pass-through payment extension for EyePoint Pharmaceuticals (EYPT)?

The extension allows DEXYCU to remain covered for an additional nine months, facilitating access for Medicare patients undergoing cataract surgery.

When will the final ruling on the pass-through payment status for DEXYCU be released?

The final ruling from CMS is anticipated in November 2021.

How does DEXYCU's pass-through status benefit patients?

It ensures coverage for outpatient drug administration during cataract surgeries, benefiting the majority of Medicare Part B patients.

What percentage of cataract surgery patients are covered by Medicare?

Approximately 60% of patients undergoing cataract surgery are covered by Medicare Part B.