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Positive Results from Phase 2 Presbyopia (VEGA-1) and Phase 3 Reversal of Mydriasis (MIRA-2) Studies to be Presented at 2021 ASCRS Annual Meeting in Las Vegas
Ocuphire Presenting Nyxol® + Low Dose Pilocarpine Phase 2 Data in the Presbyopia Industry Panel at Eyecelerator@ASCRS in Las Vegas
Ocuphire to Highlight Novel Refractive and Retinal Approaches in Ophthalmology at Eye on Innovation Demy-Colton Virtual Salon Series
FARMINGTON HILLS, Mich., July 13, 2021 (GLOBE NEWSWIRE) -- Ocuphire Pharma, Inc. (Nasdaq: OCUP), a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing therapies for the treatment of several eye disorders, today announced that Dr. Jay S. Pepose, Medical Advisor and Board Director, will be presenting two papers on presbyopia and reversal of mydriasis (RM) at the 2021 American Society of Cataract and Refractive Surgery (ASCRS) Annual Meeting being held on July 23-27, 2021 and that Mina Sooch, CEO and Board Director, will be participating in the presbyopia industry panel at the Eyecelerator on July 22, 2021 and in the Eye on Innovation panel at the Virtual Salon Series on July 28, 2021.
“We are excited to share more broadly the results from our two Nyxol® programs in reversal of mydriasis and presbyopia at these global industry forums with physicians, strategic partners, and investors,” said Mina Sooch, MBA, President and CEO of Ocuphire Pharma. “We remain on track with our plans for the potential NDA submission for Nyxol in RM in late 2022. With respect to our presbyopia program, we believe the recently announced favorable safety profile and positive efficacy data from our Phase 2 VEGA-1 study position Nyxol + low dose pilocarpine to be a potentially best-in-class product for this extremely large age-related patient population. In the Presbyopia New Treatments session at ASCRS, Ocuphire will present new and differentiated data alongside the most advanced program AGN-190584 by Abbvie/Allergan.”
Presbyopia: Everybody gets it but... can it be fixed?
Thursday, July 22nd, 2021
Mandalay Bay South Convention Center, Las Vegas
2:15-2:55 pm PDT
Ocuphire, Mina Sooch, CEO (together with five leading companies in late-stage clinical development of eye drops for presbyopia)
2021 ASCRS Annual Meeting
Phase 2 Clinical Trial to Evaluate the Efficacy of Phentolamine Ophthalmic Solution and Low-Dose Pilocarpine for the Treatment of Presbyopia
Sunday, July 25th, 2021
8:45 am – 8:50 am PDT
Mandalay Bay Convention Center, Las Vegas
Jay S. Pepose, MD, PhD, ABO
Phase 3 Clinical Trial to Evaluate the Efficacy of Phentolamine Ophthalmic Solution on the Reversal of Pharmacologically Induced Mydriasis
Monday, July 26th, 2021
4:25 pm – 4:30 pm PDT
Mandalay Bay Convention Center, Las Vegas
Jay S. Pepose, MD, PhD, ABO
Demy-Colton Virtual Salon Series
Ophthalmic Drug Delivery: Eye on Innovation
Wednesday, July 28th, 2021
11:00 am – 12:15 pm ET
Mina Sooch, CEO
About Ocuphire Pharma
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 9 clinical trials including the recently completed Phase 3 trial in RM and Phase 2 trial in presbyopia. Ocuphire reported positive topline data in March 2021 for MIRA-2, a Phase 3 FDA registration study for treatment of RM. Ocuphire also reported positive top-line data in June 2021 for VEGA-1, a Phase 2 trial for the treatment of presbyopia. Nyxol is also currently in Phase 3 clinical development for NVD. 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 in RM (NCT04620213), recently completed Phase 2 trial in presbyopia (NCT04675151), ongoing Phase 3 registration trial in NVD (NCT04638660), and Phase 2 trial in DR/DME (NCT04692688). For more information, please visit www.ocuphire.com.
Forward Looking Statements
Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements concerning a potential Phase 3 trial in presbyopia, Nyxol + LDP’s potential to be a ‘best in class’ presbyopia treatment option, and the market and commercial potential of Nyxol + LDP. These forward-looking statements are based upon Ocuphire’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, including, without limitation: (i) the success and timing of regulatory submissions and pre-clinical and clinical trials, including enrollment and data readouts; (ii) regulatory requirements or developments; (iii) changes to clinical trial designs and regulatory pathways; (iv) changes in capital resource requirements; (v) risks related to the inability of Ocuphire to obtain sufficient additional capital to continue to advance its product candidates and its preclinical programs; (vi) legislative, regulatory, political and economic developments, (vii) changes in market opportunities, (viii) the effects of COVID-19 on clinical programs and business operations, (ix) the success and timing of commercialization of any of Ocuphire’s product candidates and (x) the maintenance of Ocuphire’s intellectual property rights. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the risk factors detailed in documents that have been and may be filed by Ocuphire from time to time with the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Ocuphire undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
Corey Davis, Ph.D.