Ocuphire Granted Two New US Patents Covering Late-Stage Drug Candidate Nyxol Including for the Treatment of Presbyopia

Ocuphire Pharma announced that the United States Patent and Trademark Office (USPTO) has issued two patents covering the company’s late-stage product candidate, Nyxol (phentolamine mesylate). Both patents are directed to categories of subject matter eligible for listing in the U.S. FDA Orange Book:   

• Nyxol for Treatment of Presbyopia: U.S. Patent No. 10,993,932 issued on May 4, 2021 with claims to methods of treating presbyopia using a combination of phentolamine mesylate and low-dose pilocarpine. The term of this patent is to year 2039.
• Nyxol for Daily Administration: U.S. Patent No. 11,000,509 issued on May 11, 2021 with claims to methods of improving visual performance by daily administration of phentolamine mesylate at or near bedtime of the patient alone or in combination with one or more additional therapeutic agents. The term of the patent is to year 2034.

“We are quite pleased to announce the issuance of these two new U.S. patents that further strengthen our already robust patent portfolio for Nyxol,” Mina Sooch, MBA, President and CEO of Ocuphire Pharma, said in a company news release. “As we continue to meet milestones in our ongoing clinical trials investigating Nyxol for various refractive indications, patents like these provide the protection necessary to ensure commercial success. Importantly, Ocuphire owns all of the worldwide rights to Nyxol for all indications. These broader and new claims for daily use and presbyopia respectively reflect several years of strategic effort by our team and our patent counsel Dechert LLP. The timing is ideal with our recent announcement of enrollment completion in the VEGA-1 phase 2 presbyopia trial and the upcoming expected topline results by the end of June.”

Nyxol Eye Drops Patent Estate

Ocuphire’s patent estate for Nyxol includes patents and patent applications for phentolamine mesylate formulations and methods of using phentolamine mesylate. Patent expiry on issued patents in the U.S. and globally are at least through 2034. As of May 17, 2021, Ocuphire’s patent estate relating to Nyxol contains seven issued U.S. patents, five pending U.S. non-provisional patent applications, one pending U.S. provisional patent application, as well as issued patents in Australia, Europe, Japan, and Mexico and pending patent applications in Australia, Canada, Japan, and other foreign countries. Ocuphire owns all of the worldwide rights to Nyxol for all indications.