NovaBay Pharmaceuticals and Eyenovia Commence Co-Promotion Activities

Business Wire 1-Jul-2024 6:50 AM

Partnership co-promoting NovaBay's Avenova^® Antimicrobial Lid & Lash Solution to large ophthalmic surgery centers along with one of Eyenovia's FDA-approved product MydCombi™

Preparing for Eyenovia's launch of clobetasol propionate ophthalmic suspension, 0.05% to U.S. eyecare professionals

NovaBay^® Pharmaceuticals, Inc. (NYSE:NBY), a company developing and commercializing high-quality eyecare products, and Eyenovia, Inc. (NASDAQ:EYEN), a commercial-stage ophthalmic company with two FDA-approved products and a late-stage asset in pediatric progressive myopia, have commenced activities under a previously announced co-promotion agreement.

Under the agreement, Eyenovia is leveraging its ten-person field salesforce to promote NovaBay's Avenova Antimicrobial Lid & Lash Solution to large ophthalmic surgery centers along with one of Eyenovia's other FDA-approved products, MydCombi for mydriasis. In parallel, NovaBay has initiated reconnaissance and market preparation activities ahead of Eyenovia's launch of Clobetasol Propionate Ophthalmic Suspension, 0.05%, an innovative, rapid, sustained and more convenient solution for the treatment of postoperative inflammation and pain. Clobetasol is expected to be commercially available in August 2024. NovaBay will conduct outreach through its telephone-based physician dispensed channel to supplement geographic areas not covered by Eyenovia.

"We are excited the Eyenovia team is now selling prescription Avenova and look forward to offering Clobetasol as a complementary product to our nationwide established network of thousands of eyecare professionals," said Justin Hall, CEO of NovaBay. "This partnership is a cost-efficient means of generating greater awareness among eyecare professionals for both companies' products and provides an opportunity for us to further build our physician dispensed channel by promoting the first new ophthalmic steroid to enter the U.S. market in more than 15 years."

"Avenova is long established as the leading doctor-recommended hypochlorous-based lid and lash spray, making it ideal for our highly differentiated prescription ophthalmic product portfolio," stated Michael Rowe, CEO of Eyenovia. "We are delighted to offer this complementary, high-quality product through our sales team and to strengthen relationships with eyecare professionals prior to Clobetasol's launch later this summer."

Prescription Avenova is available through EyenoviaRx.com and Avenova.com. The non-prescription product is available directly to consumers through Amazon.com and other retailers.

About Clobetasol Propionate Ophthalmic Suspension, 0.05% Clobetasol, developed by Formosa Pharmaceuticals, was granted U.S. Food and Drug Administration (FDA) approval on March 4, 2024, based on clinical results showing nearly nine out of ten patients achieving complete absence of post-surgical pain and six out of ten achieving total absence of inflammation within 15 days post-ocular surgery. Eyenovia acquired the U.S. commercial rights to Clobetasol from Formosa Pharmaceuticals in August 2023. Clobetasol offers a convenient dosing regimen of one drop, twice daily for two weeks, whereas most other post-surgical eye drops for the treatment of pain and inflammation are dosed up to four times each day.

PLEASE GO TO CLOBETASOLBID.COM FOR IMPORTANT SAFETY INFORMATION for Clobetasol Proprionate Ophthalmic Suspension 0.05%

PLEASE GO TO MYDCOMBI.COM FOR IMPORTANT SAFETY INFORMATION for MYDCOMBI™ (tropicamide and phenylephrine hydrochloride ophthalmic spray) 1%/2.5%

About Avenova Manufactured in the U.S., Avenova spray is formulated with NovaBay's patented, proprietary, stable and pure form of hypochlorous acid. It is clinically proven to kill a broad spectrum of bacteria to help relieve the symptoms of bacterial dry eye yet is non-irritating and completely safe for regular use. A non-prescription version of Avenova is available directly to consumers through online distribution channels such as Amazon.com and Avenova.com.

About Eyenovia, Inc. Eyenovia, Inc. (NASDAQ:EYEN) is an ophthalmic technology company commercializing MydCombi™ (tropicamide and phenylephrine hydrochloride ophthalmic spray) 1%/2.5% for mydriasis, Clobetasol Propionate Ophthalmic Suspension, 0.05% for postsurgical inflammation and pain, and developing the Optejet^® device for use both in connection with its own drug-device therapeutic product for pediatric progressive myopia as well as out-licensing for additional indications. For more information, please visit Eyenovia.com.

The Eyenovia Corporate Information slide deck may be found at ir.eyenovia.com/events-and-presentations.

About NovaBay Pharmaceuticals, Inc. NovaBay's leading product Avenova^® Antimicrobial Lid & Lash Solution is often prescribed by eyecare professionals for blepharitis and dry eye disease and is available directly to consumers through online distribution channels such as Amazon.com. It is clinically proven to kill a broad spectrum of bacteria to help relieve the symptoms of bacterial dry eye, yet is non-irritating and completely safe for regular use. In addition to this Avenova OTC product line, NovaBay offers the Avenova Allograft, an amniotic tissue prescription-only product, is available through eyecare professionals in the United States.

Eyenovia Forward-Looking Statements Except for historical information, all the statements, expectations and assumptions contained in this press release are forward-looking statements. Forward-looking statements include, but are not limited to, statements that express our intentions, beliefs, expectations, strategies, predictions or any other statements relating to our future activities or other future events or conditions, including estimated market opportunities for our product candidates and platform technology, and the potential market for clobetasol propionate ophthalmic suspension 0.05%. These statements are based on current expectations, estimates and projections about our business based, in part, on assumptions made by management. These statements are not guarantees of future performance and involve risks, uncertainties and assumptions that are difficult to predict. Therefore, actual outcomes and results may, and in some cases are likely to, differ materially from what is expressed or forecasted in the forward-looking statements due to numerous factors discussed from time to time in documents which we file with the U.S. Securities and Exchange Commission.

In addition, such statements could be affected by risks and uncertainties related to, among other things: risks of our clinical trials, including, but not limited to, the costs, design, initiation and enrollment, timing, progress and results of such trials; the timing of, and our ability to submit applications for, obtaining and maintaining regulatory approvals for our products and product candidates; the potential advantages of our products, product candidates and platform technology; the rate and degree of market acceptance and clinical utility of our products and product candidates; our estimates regarding the potential market opportunity for our products and product candidates; reliance on third parties to develop and commercialize our products and product candidates; the ability of us and our partners to timely develop, implement and maintain manufacturing, commercialization and marketing capabilities and strategies for our products and product candidates; intellectual property risks; changes in legal, regulatory, legislative and geopolitical environments in the markets in which we operate and the impact of these changes on our ability to obtain regulatory approval for our products; and our competitive position.

Any forward-looking statements speak only as of the date on which they are made, and except as may be required under applicable securities laws, Eyenovia does not undertake any obligation to update any forward-looking statements.

NovaBay Pharmaceuticals Forward-Looking Statements Except for historical information herein, matters set forth in this press release may be forward looking within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including statements about the commercial progress and future financial performance of NovaBay Pharmaceuticals, Inc. This release contains forward-looking statements that are based upon management's current expectations, assumptions, estimates, projections and beliefs. These statements include, but are not limited to, statements regarding to potential financial impact of co-promotion agreements, as well as generally the Company's expected future financial results. These statements involve known and unknown risks, uncertainties and other factors that may cause actual results or achievements to be materially different and adverse from those expressed in or implied by the forward-looking statements. Factors that might cause or contribute to such differences include, but are not limited to, risks and uncertainties relating to the size of the potential market for our products, the possibility that the available market for the Company's products will not be as large as expected, the Company's products will not be able to penetrate one or more targeted markets, and revenues will not be sufficient to meet the Company's cash needs. Other risks relating to NovaBay's business, including risks that could cause results to differ materially from those projected in the forward-looking statements in this press release, are detailed in NovaBay's latest Form 10-Q/K filings and Registration Statement on Form S-1 filing with the Securities and Exchange Commission, especially under the heading "Risk Factors." The forward-looking statements in this release speak only as of this date, and NovaBay disclaims any intent or obligation to revise or update publicly any forward-looking statement except as required by law.

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