Chloramphenicol/Colistimethate sodium

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.” 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. 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. 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). 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. The content above comes from the network. if any infringement, please contact us to modify.

TAIPEI, March 4, 2024 /PRNewswire/ -- Taiwan-based Formosa Pharmaceuticals (6838.TWO) and AimMax Therapeutics (United States) announced today that the U.S. Food and Drug Administration (FDA) has approved clobetasol propionate ophthalmic suspension 0.05% (APP13007), for the treatment of post-operative inflammation and pain following ocular surgery. Utilizing a super potent corticosteroid, clobetasol propionate ophthalmic suspension 0.05% is derived from Formosa Pharma's proprietary APNT™ nanoparticle formulation platform. This innovative formulation represents the first FDA-approved ophthalmic clobetasol propionate product and the first new steroid in over 15 years on the ophthalmic market, offering patients a convenient and straightforward dosing regimen (twice daily for 14 days without tapering). Two Phase 3 clinical trials demonstrated rapid and sustained clearance of inflammation and pain relief that was statistically and clinically superior to its matching placebo (p<0.001). This novel eyedrop enters a $1.3 billion dollar market for topical ophthalmic steroids and steroid combinations, driven by an estimated seven million ocular surgeries performed annually in the United States. "This approval marks Formosa Pharma's entry into the global marketplace and provides a critical foundation and momentum for continued development, as well as advancement of new endeavors. With immense gratitude, we thank our development colleagues at AimMax Therapeutics for their wisdom and tenacity in guiding the program through to success. Equally, we recognize the tireless efforts of our employees and unwavering support from colleagues in the realization of this corporate milestone," said Erick Co, President and CEO of Formosa Pharmaceuticals. With FDA approval now secured, we look forward to working with our U.S. commercialization partner, Eyenovia, Inc., to reach ophthalmologists and ocular surgery patients, while in parallel working to expand into additional territories and advance our earlier stage pipeline." "We congratulate Formosa Pharma for the achievements and are extremely pleased with the collaborative opportunity to bring this novel and impressive formulation to the market to benefit millions of patients for the ease of use and rapid recovery and regain of visual acuity after ocular surgery" said AimMax Therapeutics' Founder and Chief Executive Officer, Laurene Wang, Ph.D. "We believe clobetasol propionate ophthalmic suspension 0.05% will be a very synergistic addition to our commercial product portfolio, and we are honored that Formosa has entrusted Eyenovia with the marketing of this important asset in the United States," stated Michael Rowe, Chief Executive Officer of Eyenovia. "We are already working diligently toward a robust launch of this differentiated and desirable product mid-year, and we believe that, given its more favorable posology and profile compared to other post-surgical steroid options, it has the potential to capture a significant share of an estimated $1.3 billion annual market opportunity." About Formosa Pharmaceuticals, Inc. Formosa Pharmaceuticals, Inc. (6838.TWO) is a clinical stage biotechnology company with primary focus in the areas of ophthalmology and oncology. The company's proprietary nanoparticle formulation technology (APNT™) improves the dissolution and bioavailability of APIs for topical, oral, and inhaler administration. Subsequent formulations have high purity, uniformity, and stability, thereby allowing the utilization of poorly soluble or extremely potent drug agents which otherwise may face insurmountable challenges in delivery and penetration to target tissues. For more details about Formosa Pharma and APNT™, visit Formosapharma.com. About AimMax Therapeutics, Inc. AimMax Therapeutics, Inc., engages in the research and development of pharmaceuticals at various stages of development through its discovery or by co-development with strategic partners. The company's R&D strengths derive from extensive and synergistic experience in basic and nonclinical research, translational medicine, clinical trial design, and regulatory and commercial strategy. 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 proprietary Optejet dispensing 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% (APP13007) for pain and inflammation post ocular surgery. Eyenovia is also advancing late-stage development of medications in the Optejet device, including MicroPine for myopia progression (partnered with Arctic Vision in China and South Korea), and Apersure for presbyopia. For more information, visit Eyenovia.com. SOURCE Formosa Pharmaceuticals