Ocuphire hosts Virtual Investor R&D Day on January 31st – Tips & Results

Update on late-stage clinical trials in the APX3330 and Nyxol programs and commercial insights for Nyxol for RM and presbyopia from six leading KOLs

Webinar on Monday, January 31stSt @ 10 p.m. ET

FARMINGTON HILLS, Mich., Jan. 25, 2022 (GLOBE NEWSWIRE) — Ocuphire Pharma, Inc. (Nasdaq: OCUP), a clinical-stage ophthalmology biopharmaceutical company focused on the development and commercialization of therapies for the treatment of refractive diseases and Retinal Eye Diseases, announced today that it will host a Virtual Investor R&D Day on Monday, January 31, 2022 from 10:00 a.m. to 12:15 p.m. ET.

The Ocuphire Investor R&D Day will feature six Key Opinion Leaders (KOLs) from the fields of refractive surgery, optometry and the retinal practice of ophthalmology, who will share their thoughts on three major unmet indications being addressed by Ocuphire’s two late-stage clinical compounds will. Two leading indications for Nyxol®, reversal of pharmacologically induced mydriasis (RM) (reversal of dilated pupils) and presbyopia (age-related blurred near vision), and 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 results from 2021, status updates for ongoing clinical trials, a preview of the catalysts expected for 2022, including a potential NDA filing for the RM indication, and anticipated commercial momentum 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 diseases; its second product candidate, APX3330, is a first-in-class oral Ref-1 inhibitor with a novel dual anti-VEGF and anti-inflammatory mechanism for the treatment of diabetic retinal disease.

Mina Sooch, MBA, CEO and Founder of Ocuphire Pharma said, “The KOLs attending our upcoming Investor R&D Day have made a name for themselves in the retinal space as panelists, authors, clinical investigators, educators, innovators and commercially-minded physicians , anterior section and optometry done . We look forward to their insights into the evolving landscape, addressable markets, and the differentiated and innovative drug candidates that Ocuphire’s Nyxol and APX3330 offer for the elimination of mydriasis, presbyopia and diabetic eye disease.”

Key opinion leaders include:

  • David Boyer, MD – Retina-Vitreous Assoc. Medical Group, Los Angeles, CA
  • Peter Kaiser, MD – Cole Eye Institute, Cleveland Clinic, Cleveland, OH
  • Paul Karpecki, OD, FAAO – Kentucky Eye Institute, Lexington, KY
  • Mitchell Jackson, MD – Jacksoneye, Lake Villa, IL
  • Jay Pepose, MD, Ph.D. – Pepose Vision Institute, St. Louis, MO
  • James Katz, MD—Midwest Center for Sight, Des Plaines, IL

The Investor R&D Day agenda begins with Mina Sooch, CEO of Ocuphire, providing a company overview. Mark Kelley, Ph.D., Scientific Advisor to the APX program and discoverer of the Ref-1 target, will provide an overview of the mechanism and preclinical data of APX3330. dr Kaiser and Boyer will present the previous APX3330 clinical safety data and provide an update on the ongoing ZETA-1 Phase 2b DR study. dr Karpecki and Jackson will discuss the positive Phase 3 MIRA-2 results for Nyxol in reversing mydriasis and the important addressable market that currently has no commercially available treatment options. Bindu Manne, the newly appointed Head of Market Development and Commercialization at Ocuphire, will join the KOLs and discuss current patient-physician dynamics and the utility of Nyxol for RM in various areas of ophthalmology. Finally, dr. Pepose and Katz will discuss the positive Phase 2 results of VEGA-1 in light of the recent launch of Allergan’s (an AbbVie company) Vuity™, the first FDA-approved eye drop treatment for presbyopia, and updates on the planned clinical phase 3 of VEGA give 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 the development and commercialization of therapies to treat various eye diseases. 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 eye solution), is a once-daily, preservative-free eye drop formulation of phentolamine mesylate, a non-selective alpha-1 and alpha-2 adrenergic antagonist useful for reducing Pupil was sized and is being developed for multiple indications including reversal of pharmacologically induced mydriasis (RM), presbyopia and low light or night vision disorders (NVD) and has been evaluated in 9 completed clinical studies by the end of 2021. Ocuphire reported positive top-line data in March 2021 for MIRA-2, the first pivotal Phase 3 study in RM, and recently initiated the second pivotal Phase 3 study (MIRA-3) in RM. Ocuphire also reported positive top-line data for VEGA-1, a Phase 2 study in the treatment of presbyopia, in June 2021. Nyxol has also currently completed recruitment for its Phase 3 clinical development in NVD and has initiated a pediatric study in RM (MIRA-4). Ocuphire’s second product candidate, APX3330, is an oral tablet designed to inhibit angiogenesis and inflammatory pathways relevant to retinal and choroidal vascular diseases such as diabetic retinopathy (DR) and diabetic macular edema (DME) and has been developed in 11 phases 1 and 2 examines experiments. APX3330 is currently enrolling in a Phase 2 clinical trial (ZETA-1) in subjects with DR/DME. As part of its strategy, Ocuphire will continue to evaluate opportunities to acquire additional ophthalmic assets and seek strategic partners for late-stage development, pre-registration and commercialization of drugs in key global markets. Please visit www.clinicaltrials.gov to learn more about Ocuphire’s ongoing 2ndnd Pivotal Phase 3 study in RM (NCT05134974) and Phase 2 study in DR/DME (NCT04692688). Ocuphire previously graduated from the 1St Pivotal phase 3 study in RM (NCT04620213), phase 2 study in presbyopia (NCT04675151) and enrollment in the pivotal phase 3 study in NVD (NCT04638660). Visit www.ocuphire.com for more information.

Forward-Looking Statements
Statements 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 regarding future clinical trials in RM, Presbyopia , NVD and DR/DME. These forward-looking statements are based on Ocuphire’s current expectations and involve assumptions that may never come to pass or prove to be incorrect. Actual results and timing of events could differ materially from those anticipated in such forward-looking statements due to various risks and uncertainties, including but not limited to: (i) the success and timing of regulatory filings and pre-clinical and clinical trials, including registration and data reading; (ii) regulatory requirements or developments; (iii) changes in clinical trial designs and regulatory pathways; (iv) changes in capital requirements; (v) risks related to Ocuphire’s inability to raise sufficient additional capital to further advance its product candidates and preclinical programs; (vi) legal, regulatory, political and economic developments, (vii) changes in market opportunities, (viii) the impact of COVID-19 on clinical programs and business operations, (ix) the success and timing of commercialization of any Ocuphire candidate product and (x) respecting Ocuphire’s intellectual property rights. The foregoing summary 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 the statements contained herein and elsewhere, including the risk factors contained in documents that have been filed and may be filed by Ocuphire from time to time with the SEC. Any forward-looking statements contained in this press release speak only as of the date they are made. Ocuphire undertakes no obligation to update any such statements to reflect events or circumstances after the date on which they are made.

Ocuphire contacts
Mina Sooch, President and CEO
Ocuphire Pharma, Inc.
ir@ocuphire.com
www.ocuphire.com

Corey Davis, Ph.D.
LifeSci Advisor
cdavis@lifesciadvisors.com

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