Update on Late-Stage Clinical Trials in the APX3330 and Nyxol Programs as well as Commercial Insights for Nyxol for RM and Presbyopia by Six Leading KOLs
Webinar to Take Place on Monday, January 31st @ 10am ET
FARMINGTON HILLS, Mich., Jan. 25, 2022 (GLOBE NEWSWIRE) -- Ocuphire Pharma, Inc. (Nasdaq: OCUP), a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing therapies for the treatment of refractive and retinal eye disorders, today announced that it will host a virtual investor R&D Day on Monday, January 31, 2022 from 10:00am to 12:15pm ET.
The Ocuphire Investor R&D Day will feature six ophthalmic Key Opinion Leaders (KOLs) from refractive surgery, optometry and retina practice areas who will share their thoughts on three large unmet indications addressed by Ocuphire’s two late-stage clinical drug assets. Two leading indications for Nyxol®, reversal of pharmacologically-induced mydriasis (RM) (reversing dilated pupils) and presbyopia (age-related blurry near vision) will be discussed as will APX3330 for diabetic retinopathy (DR) (a leading cause of vision loss due to diabetes). Topics will include a review of previous Phase 2 and 3 readouts from 2021, status updates for ongoing clinical trials, a preview of expected 2022 catalysts including a potential NDA submission for the RM indication, and prospective commercial dynamics and competitive positioning of Nyxol in RM and presbyopia, and APX3330 in retinal diseases.
Ocuphire’s lead product candidate, Nyxol eye drops (0.75% phentolamine ophthalmic solution), is a non-selective alpha-1 and alpha-2 adrenergic inhibitor for the treatment of refractive conditions; its second product candidate, APX3330, is an first-in-class oral Ref-1 inhibitor with a novel, dual anti-VEGF and anti-inflammatory mechanism for the treatment of diabetic retinal diseases.
Mina Sooch, MBA, CEO and founder of Ocuphire Pharma, said, “The KOLs participating at our upcoming Investor R&D Day have earned distinction in retina, anterior segment and optometry as panelists, authors, clinical investigators, educators, innovators and commercially-minded physicians. We look forward to their insights on the evolving landscape, the addressable markets, and the differentiated and innovative drug candidates offered by Ocuphire’s Nyxol and APX3330 across reversal of mydriasis, presbyopia, and diabetic eye diseases.”
Slate of Key Opinion Leaders include:
David Boyer, M.D. – Retina-Vitreous Assoc. Medical Group, Los Angeles, CA
Peter Kaiser, M.D. – Cole Eye Institute, Cleveland Clinic, Cleveland, OH
Paul Karpecki, O.D., F.A.A.O. – Kentucky Eye Institute, Lexington, KY
Mitchell Jackson, M.D. – Jacksoneye, Lake Villa, IL
Jay Pepose, M.D., Ph.D. – Pepose Vision Institute, St. Louis, MO
James Katz, M.D. – Midwest Center for Sight, Des Plaines, IL
The agenda for the Investor R&D day will kick-off with Mina Sooch, CEO of Ocuphire providing a company overview. Mark Kelley, Ph.D., scientific advisor for the APX Program and discoverer of the Ref-1 target, will provide an overview of APX3330’s mechanism and preclinical data. Drs. Kaiser and Boyer will present APX3330’s prior clinical safety data and provide an update on the ongoing ZETA-1 Phase 2b DR study. Drs. Karpecki and Jackson will discuss the positive Phase 3 MIRA-2 results for Nyxol in reversal of mydriasis, and the significant addressable market where there are currently no commercially available treatment options. Bindu Manne, Ocuphire’s newly appointed Head of Market Development and Commercialization, will join the KOLs and discuss the current patient-physician dynamic and the utility of Nyxol for RM across different eyecare practice areas. Lastly, Drs. Pepose and Katz will discuss the positive VEGA-1 Phase 2 results in light of the recent launch of Vuity™ by Allergan (an AbbVie Company), the first FDA-approved eyedrop treatment for presbyopia, and provide updates on the planned VEGA Phase 3 clinical programs.
Each of these presentations will be followed by a live Q&A session. To register for the R&D Day, please click here.
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 refractive and retinal indications. The company’s lead product candidate, Nyxol® eye drops (0.75% phentolamine ophthalmic solution) 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 reversal of pharmacologically-induced mydriasis (RM), presbyopia and dim light or night vision disturbances (NVD), and has been studied in 9 completed clinical trials through the end of 2021. Ocuphire reported positive top-line data in March 2021 for MIRA-2, the first Phase 3 registration trial for treatment of RM, and recently initiated the second Phase 3 registration trial (MIRA-3) in RM. Ocuphire also reported positive top-line data in June 2021 for VEGA-1, a Phase 2 trial for the treatment of presbyopia. Nyxol also currently completed enrollment in its Phase 3 clinical development for NVD and launched a pediatric trial in RM (MIRA-4). 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 (ZETA-1) 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 ongoing 2nd Phase 3 registration trial in RM (NCT05134974), and Phase 2 trial in DR/DME (NCT04692688). Ocuphire previously completed the 1st Phase 3 registration trial in RM (NCT04620213), Phase 2 trial in presbyopia (NCT04675151) and enrollment in the Phase 3 registration trial in NVD (NCT04638660). For more information, 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 the future clinical trials in RM, presbyopia, NVD and DR/DME. 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.