Phenylephrine Hydrochloride

Eyenovia, Inc. and Betaliq, Inc. could potentially be heading toward a “reverse merger transaction” to form a new ophthalmic company, the companies recently announced. We’ll start with Eyenovia. Based in New York, the commercial-stage ophthalmic pharmaceutical technology company is developing a pipeline of micro-dosed treatments for front-and-back-of-eye diseases, including presbyopia, mydriasis, and myopia. On the regulatory side: The company’s Mydcombi (tropicaide and phenylephrine hydrochloride ophthalmic spray) 1% / 2.5% for inducing mydriasis was cleared by the FDA in 2023. The Optejet device is exclusively designed for ocular therapeutics as a way to dispense topical eye medications using Eyenovia’s Microdose Array Print (MAP) technology as a topical delivery system (similar to an inkjet printer). The process: Medication is dispensed horizontally in a mist to coat the surface of the cornea, with contact to the eye occurring at a low velocity to reduce ocular impact. The glaucoma-focused, clinical-stage pharmaceutical company—launched via a collaboration with Novaliq GmbH—is developing a portfolio of topical glaucoma treatments featuring a unique delivery system of its own. Eyenovia entered into a non-binding LOI with Betaliq to consider a reverse merger transaction to create a new ophthalmic company focused on the aforementioned proprietary technologies. Its proposed therapeutic focus: glaucoma. While both the Optejet and EyeSol platforms provide similar benefits for enhancing products’ ease of use and compliance with therapeutics, the companies also noted that—most importantly—EyeSol is compatible with the Optejet. Plus: EyeSol delivers a 10 microliters (µL) drop size that can be replicated in the Optejet device. There is, actually. Per the companies, the value for each—assuming zero cash (net of liabilities) at the closing of this potential merger—would be: For equity holders: As a result of this exchange ratio, the intent would be for Betaliq and Eyenovia equity holders to own an estimated 83.7% and 16.3% of the newly-combined company, respectively. Eyenovia CEO Michael Rowe stated that a potential merger is “in the best interests of our company, our team members, patients, and shareholders.” Similarly: Betaliq CEO Barry Butler emphasized the “significant opportunity in the eyecare space” that the joining of both technologies could represent for patients with glaucoma and other ocular diseases—not to mention opportunities for pipeline expansion. No exact timeframe has been shared so far. Even further: The deal will be contingent on a number of factors and definitive agreements from both sides. There are! Eyenovia plans to file for U.S. regulatory approval of a user-filled version of the Optejet, designed to operate with a number of topical ophthalmic liquids such as artificial tears and rewetting products. So on both fronts—this merger and the user-filled Optejet—stay tuned for news!

AMERICAN FORK, Utah--( BUSINESS WIRE )--Today, Nathan Jones, CEO of Xlear Inc., a consumer hygiene products company, released this statement regarding the FDA’s proposal to remove popular over-the-counter decongestants, which contain the drug phenylephrine, from the market: “With the FDA concluding that this common decongestant isn’t effective, as we enter cold and flu season, and as families prepare to celebrate the holidays, many Americans need a new answer for the discomfort of sinus congestion,” Jones noted. “For people looking for help, the U.S. Centers for Disease Control (CDC) Guidance, ‘Relief for Symptoms of Colds and Coughs’, ‘instructions’ say to ‘use saline nasal spray to relieve congestion.’ i Similarly, CDC’s ‘Sinus Infection Basics’ say ‘How to Feel Better’ ‘use a . . . saline nasal spray,’” ii he pointed out. “You experience congestion because there is an irritant or pathogen in your upper airway that your body is trying to trap and wash away—your runny nose is your body flushing it out. Saline-based nasal sprays can help speed up that flushing, reduce pathogen load, and make it more effective. It’s commonsense: The faster the bad stuff is gone, the faster you feel better,” Jones added. “For congestion caused by pathogens—like colds and flus—people can enhance that effect by using a nasal spray that contains xylitol. A series of studies show xylitol (a natural sugar) deactivates and/or blocks the adhesion of many types of viruses and bacteria, to your airway cells,” iii Jones continued. Adhesion is the process by which a pathogen attaches to your tissue to initiate infection. Using a nasal spray with xylitol helps block adhesion of these pathogens. For example, a Randomized Controlled (clinical) Trial published in 2022, determined that a saline-nasal spray containing xylitol and other ingredients reduced the rate of COVID-19 infections by 62 percent above placebo. iv “Using a basic saline would be comparable to rinsing your hands with water; using a nasal spray with xylitol, like Xlear , would be comparable to washing your hands with soap. Expect more from your nasal hygiene products. Make sure they have xylitol so you can better and faster clean out the bad stuff while alleviating the congestion,” Jones added. Xlear nasal spray is a saline-based nasal spray containing xylitol. Xlear 12 Hour Nasal Decongestant is a saline-based nasal spray containing xylitol and the decongestant Oxymetazoline HCL. For more information on Xlear please visit www.xlear.com . ____________________________ i https://www.cdc.gov/antibiotic-use/media/pdfs/HCP-Relief-Colds-Cough-85by11-P.pdf ii https://www.cdc.gov/sinus-infection/about/index.html iii For example: T Kontiokari, M Uhari, M Koskela, Antiadhesive effects of xylitol on otopathogenic bacteria., Journal of Antimicrobial Chemotherapy , Volume 41, Issue 5, May 1998, Pages 563–565, https://academic.oup.com/jac/article-abstract/41/5/563/652694?redirectedFrom=fulltext - google_vignette ; Kontiokari, T., Uhari, M., & Koskela, M. (1998). Antiadhesive effects of xylitol on otopathogenic bacteria. The Journal of Antimicrobial Chemotherapy , 41 (5), 563–565, https://academic.oup.com/jac/article-abstract/41/5/563/652694?redirectedFrom=fulltext&login=false ; Jung, Kie Hoon. (2021). Antiviral Efficacy Against Virus Infections in Human-Derived Tracheal/Bronchial Epithelial Cells. Utah State University, https://xlrtmp.com/wp-content/uploads/2023/05/Antiviral-efficacy_USU2021.pdf ; Vega, J. C., et al., (2020). Iota carrageenan and xylitol inhibit SARS-CoV-2 in Vero cell culture. BioRxiv , https://professionals.xlear.com/portfolio/anti-adherence-of-viruses/ ; Ruiz, V., Rodríguez-Cerrato, V., Huelves, L. et al. Adherence of Streptococcus pneumoniae to Polystyrene Plates and Epithelial Cells and the Antiadhesive Potential of Albumin and Xylitol. Pediatr Res 69, 23–27, https://www.nature.com/articles/pr920116 - citeas . iv Damian Balmforth, et al., Evaluating the efficacy and safety of a novel prophylactic nasal spray in the prevention of SARS-CoV-2 infection: A multi-centre, double blind, placebo-controlled, randomised trial., Journal of Clinical Virology, 155; 2022, https://www.sciencedirect.com/science/article/pii/S1386653222001809 .