Ocuphire Granted Two New US Patents Covering Late-Stage Drug Candidate 

Ocuphire Pharma, Inc. recently announced 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:  US 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:  US 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 US patents that further strengthen our already robust patent portfolio for Nyxol,” said Mina Sooch, MBA, President and CEO of Ocuphire Pharma. “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 top-line results by the end of June.”

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 US and globally are at least through 2034. As of May 17, 2021, Ocuphire’s patent estate relating to Nyxol contains seven issued US patents, five pending US non-provisional patent applications, one pending US 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.

Ocuphire is a publicly traded (NASDAQ: OCUP), clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing therapies for the treatment of several eye disorders. Ocuphire’s pipeline currently includes two small-molecule product candidates targeting front and back of the eye indications. The company’s lead product candidate, Nyxol (0.75% phentolamine ophthalmic solution) Eye Drops, is a once-daily preservative-free eye drop formulation of phentolamine mesylate, a non-selective alpha-1 and alpha-2 adrenergic antagonist designed to reduce pupil size, and is being developed for several indications, including dim light or night vision disturbances (NVD), reversal of pharmacologically-induced mydriasis (RM), and presbyopia, and has been studied in 8 clinical trials including the recently completed Phase 3 trial in RM. Ocuphire reported positive topline data in March 2021 for MIRA-2, a Phase 3 FDA registration study for treatment of RM. Nyxol is also currently in Phase 3 clinical development for NVD and in Phase 2 for presbyopia. Ocuphire’s second product candidate, APX3330, is an oral tablet designed to inhibit angiogenesis and inflammation pathways relevant to retinal and choroidal vascular diseases, such as diabetic retinopathy (DR) and diabetic macular edema (DME) and has been studied in 11 Phase 1 and 2 trials. APX3330 is currently enrolling subjects in a Phase 2 clinical trial in subjects with DR/DME. As part of its strategy, Ocuphire will continue to explore opportunities to acquire additional ophthalmic assets and to seek strategic partners for late-stage development, regulatory preparation, and commercialization of drugs in key global markets. Please visit www.clinicaltrials.gov to learn more about Ocuphire’s completed Phase 2 trials, recently completed Phase 3 registration trial (NCT04620213), ongoing Phase 3 registration trial (NCT04638660), Phase 2 trial in presbyopia (NCT04675151), and Phase 2 trial in DR/DME (NCT04692688). For more information, visit www.ocuphire.com.