NovaBay Pharmaceuticals and Eyenovia to Co-Promote Prescription Ophthalmic Products to U.S. Eyecare Professionals

2024-03-13

临床结果临床3期上市批准

March 13, 2024 -- NovaBay Pharmaceuticals, Inc. (NYSE American: NBY) and Eyenovia, Inc. (Nasdaq: EYEN) announced the signing of a co-promotion agreement to commercialize prescription ophthalmic products to eyecare professionals across the U.S. Under the agreement, NovaBay will market Eyenovia’s clobetasol propionate ophthalmic suspension 0.05% (“Clobetasol”), a steroid indicated for the treatment of inflammation and pain following ocular surgery, through its U.S. physician-dispensed channel. Eyenovia will market NovaBay’s prescription Avenova® Antimicrobial Lid & Lash Solution through its Mydcombi and Clobetasol sales representatives strategically located across the U.S.

Clobetasol propionate ophthalmic suspension 0.05%, 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 propionate ophthalmic suspension 0.05% from Formosa Pharmaceuticals in August 2023. Clobetasol propionate ophthalmic suspension 0.05% is expected to receive a tradename as soon as this summer.

“Clobetasol propionate ophthalmic suspension 0.05% was developed to provide ophthalmologists and ocular surgery patients with a compelling, rapid, sustained and more convenient postoperative anti-inflammatory and pain relief solution. It is the first new ophthalmic steroid to enter the U.S. market in over 15 years, making it an exciting product for our physician network, and providing NovaBay with the opportunity to further leverage this channel,” said Justin Hall, CEO of NovaBay. “Our physician-dispensed channel has become increasingly important in building our Avenova business. We have found that eyecare professionals carrying our products in their offices and recommending Avenova to their patients at the time of care delivers a halo effect by stimulating online product sales.”

“NovaBay has a nationwide established network of thousands of eyecare professionals through its physician-dispensed channel, thereby presenting a ready-made opportunity to complement our established salesforce and accelerate the commercialization of this product,” stated Michael Rowe, CEO of Eyenovia. “Although Avenova Antimicrobial Lid & Lash Solution has been on the market since 2015, there is considerable opportunity to generate professional awareness and grow sales. This co-promotion agreement reflects our shared commitment to bring scientifically developed, cutting-edge and high-quality ophthalmic products to physicians and the patients they treat.”

About Clobetasol Propionate Ophthalmic Suspension 0.05%

Clobetasol propionate ophthalmic suspension 0.05% demonstrated successful Phase 3 clinical results in resolving inflammation and pain following ocular surgery in a rapid and sustained manner. Adverse events were infrequent, with none occurring in over 2% of patients. Clobetasol propionate ophthalmic suspension 0.05% offers a convenient dosing regimen of one drop, twice daily for two weeks, whereas most other post-surgical eye drops are dosed up to four times each day.

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 a commercial-stage ophthalmic pharmaceutical technology company developing a pipeline of microdose array print therapeutics based on its Optejet platform. Eyenovia is currently focused on the commercialization of Mydcombi (tropicamide+phenylephrine ophthalmic spray) for mydriasis, as well as clobetasol propionate ophthalmic suspension 0.05% to reduce pain and inflammation following ocular surgery, which was approved by the FDA on March 4, 2024.

Eyenovia is also advancing late-stage development of medications in the Optejet device for presbyopia (Apersure/MicroLine) and myopia progression (MicroPine, both partnered with Arctic Vision in China and South Korea).

About NovaBay Pharmaceuticals, Inc.:

NovaBay Pharmaceuticals, Inc. develops and sells scientifically created and clinically proven eyecare, skincare and wound care products. NovaBay’s leading product Avenova® Antimicrobial Lid & Lash Solution is often prescribed by eyecare professionals for blepharitis and dry-eye disease and is also available directly to consumers through online distribution channels such as Amazon.com. NovaBay also manufactures and sells effective, yet gentle and non-irritating wound care products. The PhaseOne® brand is distributed through commercial partners in the U.S. for professional use only, and the NeutroPhase® brand is distributed in China by China Pioneer Pharma Holdings, Limited. More information about NovaBay is available here.

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