Ocuphire Granted Two New U.S. Patents Covering Late-Stage Drug Candidate Nyxol®, Including for the Treatment of Presbyopia


Newly Issued Claims Lengthen Patent Safety to Yr 2039 for Nyxol® Mixture Remedy for Presbyopia

Supplies Broader Safety for Nyxol® Throughout Indications on Strategies of Use as Every day Administration

FARMINGTON HILLS, Mich. , Could 18, 2021 (GLOBE NEWSWIRE) — Ocuphire Pharma, Inc. (Nasdaq: OCUP), a clinical-stage ophthalmic biopharmaceutical firm targeted on growing and commercializing therapies for the remedy of a number of eye problems, introduced at the moment that america Patent and Trademark Workplace (USPTO) has issued two patents overlaying the Firm’s late-stage product candidate, Nyxol (phentolamine mesylate). Each patents are directed to classes of material eligible for itemizing within the U.S. FDA Orange Ebook:   

  • Nyxol for Remedy of Presbyopia:  U.S. Patent No. 10,993,932 issued on Could 4, 2021 with claims to strategies of treating presbyopia utilizing a mixture of phentolamine mesylate and low-dose pilocarpine. The time period of this patent is to yr 2039.
  • Nyxol for Every day Administration:  U.S. Patent No. 11,000,509 issued on Could 11, 2021 with claims to strategies of bettering visible efficiency by every day administration of phentolamine mesylate at or close to bedtime of the affected person alone or together with a number of further therapeutic brokers. The time period of the patent is to yr 2034.

“We’re fairly happy to announce the issuance of those two new U.S. patents that additional strengthen our already strong patent portfolio for Nyxol,” mentioned Mina Sooch, MBA, President and CEO of Ocuphire Pharma. “As we proceed to satisfy milestones in our ongoing medical trials investigating Nyxol for varied refractive indications, patents like these present the safety mandatory to make sure business success. Importantly, Ocuphire owns the entire worldwide rights to Nyxol for all indications. These broader and new claims for every day use and presbyopia respectively replicate a number of years of strategic effort by our staff and our patent counsel Dechert LLP. The timing is good with our latest announcement of enrollment completion within the VEGA-1 Part 2 presbyopia trial and the upcoming anticipated top-line outcomes by the top of June.”

Nyxol® Eye Drops Patent Property

Ocuphire’s patent property for Nyxol consists of patents and patent functions for phentolamine mesylate formulations and strategies of utilizing phentolamine mesylate. Patent expiry on issued patents within the U.S. and globally are at the least by way of 2034. As of Could 17, 2021, Ocuphire’s patent property referring to Nyxol comprises seven issued U.S. patents, 5 pending U.S. non-provisional patent functions, one pending U.S. provisional patent utility, in addition to issued patents in Australia, Europe, Japan, and Mexico and pending patent functions in Australia, Canada, Japan, and different overseas international locations. Ocuphire owns the entire worldwide rights to Nyxol for all indications.

About Ocuphire Pharma

Ocuphire is a publicly traded (NASDAQ: OCUP), clinical-stage ophthalmic biopharmaceutical firm targeted on growing and commercializing therapies for the remedy of a number of eye problems. Ocuphire’s pipeline presently consists of two small-molecule product candidates focusing on back and front of the attention indications. The corporate’s lead product candidate, Nyxol® (0.75% phentolamine ophthalmic answer) 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 scale back pupil dimension, and is being developed for a number of indications, together with dim gentle or night time imaginative and prescient disturbances (NVD), reversal of pharmacologically-induced mydriasis (RM), and presbyopia, and has been studied in 8 medical trials together with the not too long ago accomplished Part 3 trial in RM. Ocuphire reported constructive topline knowledge in March 2021 for MIRA-2, a Part 3 FDA registration research for remedy of RM. Nyxol can also be presently in Part 3 medical improvement for NVD and in Part 2 for presbyopia. Ocuphire’s second product candidate, APX3330, is an oral pill designed to inhibit angiogenesis and irritation pathways related to retinal and choroidal vascular ailments, equivalent to diabetic retinopathy (DR) and diabetic macular edema (DME) and has been studied in 11 Part 1 and a pair of trials. APX3330 is presently enrolling topics in a Part 2 medical trial in topics with DR/DME. As a part of its technique, Ocuphire will proceed to discover alternatives to accumulate further ophthalmic property and to hunt strategic companions for late-stage improvement, regulatory preparation, and commercialization of medication in key international markets. Please go to www.clinicaltrials.gov to study extra about Ocuphire’s accomplished Part 2 trials, not too long ago accomplished Part 3 registration trial (NCT04620213), ongoing Part 3 registration trial (NCT04638660), Part 2 trial in presbyopia (NCT04675151), and Part 2 trial in DR/DME (NCT04692688). For extra info, please go to www.ocuphire.com

Ahead Wanting Statements

Statements contained on this press launch relating to issues that aren’t historic details are “forward-looking statements” inside the that means of the Non-public Securities Litigation Reform Act of 1995. Such statements embrace, however should not restricted to, statements regarding Ocuphire’s product candidates, outcomes of ongoing and future medical trials, and commercialization and market alternatives. These forward-looking statements are primarily based upon Ocuphire’s present expectations and contain assumptions that will by no means materialize or could show to be incorrect. Precise outcomes and the timing of occasions might differ materially from these anticipated in such forward-looking statements because of varied dangers and uncertainties, together with, with out limitation: (i) the success and timing of regulatory submissions and pre-clinical and medical trials, together with enrollment and knowledge readouts; (ii) regulatory necessities or developments; (iii) modifications to medical trial designs and regulatory pathways; (iv) modifications in capital useful resource necessities; (v) dangers associated to the shortcoming of Ocuphire to acquire enough further capital to proceed to advance its product candidates and its preclinical packages; (vi) legislative, regulatory, political and financial developments, (vii) modifications in market alternatives, (viii) the results of COVID-19 on medical packages and enterprise operations, (ix) the success and timing of commercialization of any of Ocuphire’s product candidates and (x) the upkeep of Ocuphire’s mental property rights. The foregoing evaluation of vital components that might trigger precise occasions to vary from expectations shouldn’t be construed as exhaustive and must be learn along side statements which are included herein and elsewhere, together with the danger components detailed in paperwork which were and could also be filed by Ocuphire occasionally with the SEC. All forward-looking statements contained on this press launch communicate solely as of the date on which they have been made. Ocuphire undertakes no obligation to replace such statements to replicate occasions that happen or circumstances that exist after the date on which they have been made.

Ocuphire Contacts

Mina Sooch, President & CEO  

Ocuphire Pharma, Inc.  



Corey Davis, Ph.D. 

LifeSci Advisors 


Primary Logo


Source link

Related posts

Leave a Comment