Ocuphire Expands Prestigious Medical Advisory Board with Six New KOLs to Support Advancement of Late-Stage Ophthalmic Assets Nyxol® and APX3330

Rhea-AI Summary

Ocuphire Pharma, a clinical-stage ophthalmic biopharmaceutical company, has appointed six new key opinion leaders to its Medical Advisory Board. This includes renowned specialists such as David Brown and Y. Ralph Chu, who bring extensive experience in ophthalmology. The new KOLs are expected to enhance Ocuphire's clinical trial designs and regulatory interactions, supporting the development of their lead candidates, Nyxol and APX3330. The appointment aims to address unmet medical needs in ophthalmic treatments, potentially broadening the company's market reach and clinical capabilities.

Positive

• Strengthened Medical Advisory Board with six new KOLs enhances clinical expertise.
• New members expected to improve clinical trial designs and regulatory engagement.
• Broader insights may accelerate development of Nyxol and APX3330.

Negative

• Concerns about continuity and experience gaps due to significant changes in the advisory board.

FARMINGTON HILLS, Mich, Dec. 08, 2021 (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 has appointed six new key opinion leaders (KOLs) across retina, refractive surgery, and optometry to its Medical Advisory Board (MAB).

“The opportunity to assemble such a dynamic and admired roster of medical advisors is exciting and will certainly broaden Ocuphire’s potential," said Mina Sooch, Founder and CEO of Ocuphire Pharma. "In the medical community, their clinical expertise and knowledge of ophthalmic drug development have earned them global distinction as key thought-leaders, panelists, authors, clinical investigators, and commercial launch experts in the field of ophthalmology. We look forward to their invaluable contributions and insights as we advance our lead clinical assets, Nyxol^® and APX3330 in reversal of mydriasis, presbyopia, night vision disturbance, and diabetic eye diseases.”

Jay Pepose, M.D., Ph.D., Member of Ocuphire’s Board of Directors and MAB commented, “We are privileged to have the opportunity to expand Ocuphire’s roster of thought-leaders. Over the last three years, our thirteen-member MAB has been vital in the design of our well-executed clinical trials, participating in regulatory interactions, and advancing discussions with global ophthalmic strategic partners. Additionally, the MAB has played an important role in presenting Nyxol and APX3330 to the medical community through peer-reviewed publications and industry conferences. The addition of these six world-class individuals, many of whom I have had the privilege of working with over several decades, will help to advance Ocuphire’s portfolio of innovative drug candidates to address unmet medical needs of our patients.”

The new members of the Medical Advisory Board are:

Retinal Specialists

• David Brown, M.D. F.A.C.S. is the director of research at Retina Consultants of Texas, chairs the Medical Leadership Board of Retina Consultants of America (RCA), and serves on the RCA board of directors. Additionally, Dr. Brown is a Clinical Professor of Ophthalmology at Baylor College of Medicine, vice-chair for research for Houston Methodist Hospital, and is a member of NASA’s research and clinical advisory panel. Dr. Brown is a renowned leader in the retina and has published over 500 national meeting presentations, abstracts, and scientific papers, including many of the primary papers that established the use of anti-VEGF agents for AMD, retinal vein occlusion, and diabetic retinopathy (DR). He serves as a peer-reviewer for 8 ophthalmology journals and has authored 9 book chapters. Dr. Brown is an investigator in Ocuphire’s ZETA-1 Phase 2 clinical trial evaluating the safety and efficacy of oral APX3330 in patients with diabetic retinopathy.
• David Lally, M.D. F.A.S.R.S. is a retina surgeon at Baystate Medical Center, an Assistant Professor of Ophthalmology at the University of Massachusetts Medical School-Baystate, and the director of the Retina Research Institute at New England Retina Consultants. His work has been published in over 25 articles in peer-reviewed ophthalmic journals, and he has delivered over 25 presentations at national meetings. Dr. Lally is part of several clinical trial steering committees and an exceptional recruiter as principal investigator in numerous retina clinical trials. Dr. Lally is an investigator in Ocuphire’s ZETA-1 Phase 2 clinical trial.

Refractive Surgeons

• Y. Ralph Chu, M.D. is the CEO and Chief Medical Officer of the Chu Vision Institute and Chu Surgery Center in Minnesota. Dr. Chu is an internationally recognized leader, innovator, and pioneer of new technologies in cataract and refractive surgery and has been involved in over 95 clinical trials across various ophthalmic diseases. He has published over 100 national meeting presentations, abstracts, and scientific papers. Dr. Chu has also been a member of several product launch committees for refractive surgery products. Dr. Chu is a clinical investigator in Ocuphire's MIRA-3 Phase 3 clinical trial evaluating the safety and efficacy of Nyxol for reversal of mydriasis.
• James Katz, M.D. is a board-certified ophthalmologist at the Midwest Center for Sight in Chicago. Dr. Katz specializes in cornea, cataract, and refractive surgery and is well-published in distinguished ophthalmologic journals with over 50 publications and over 300 presentations. He is an editorial board member of ophthalmology publications, including Cataract & Refractive Surgery Today and Presbyopia Physician. Dr. Katz has been a principal investigator in numerous FDA trials including several studies for the treatment of presbyopia. Dr. Katz speaks and teaches nationally and internationally on cataract, presbyopia and refractive surgery, and has received several notable awards and distinctions including the American Academy of Ophthalmology Achievement Award and the CEDARS ASPENS Founders Award.
• Mitchell A. Jackson, M.D. is the founder and CEO of Jacksoneye in Illinois and has practiced as a comprehensive ophthalmologist for 28 years. Dr. Jackson has been involved in over 40 pharmaceutical and surgical device clinical studies, including several presbyopia studies. Dr. Jackson serves on 7 editorial advisory boards, including Presbyopia Physician. Dr. Jackson serves as a member of the medical advisory board of several companies, and a speaker for some of the largest ophthalmic companies. Dr. Jackson has been voted Best Cataract Surgeon in America 2021 as well as a Top 50 global Key Opinion Leaders (KOL). He is a clinical investigator in Ocuphire's MIRA-3 Phase 3 clinical trial.
  

Optometrists

• Douglas Devries, O.D. is the co-founder of Eye Care Associates of Nevada and Associate Clinical Professor of Optometry. Dr. Devries has participated in numerous clinical trials and has published over 500 national and international meeting presentations, lectures, abstracts, and scientific papers. He is an advisor and speaker for some of the largest ophthalmic pharmaceutical and device companies. He is a clinical investigator in Ocuphire's MIRA-3 Phase 3 clinical trial.
  

Additional information and biographies are available at: https://www.ocuphire.com/about/medical-advisory-board

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 reversal of pharmacologically-induced mydriasis (RM), presbyopia and dim light or night vision disturbances (NVD), 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 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 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 ongoing Phase 3 (2^nd) registration trial in RM (NCT05134974), Phase 3 registration trial in NVD (NCT04638660), and Phase 2 trial in DR/DME (NCT04692688). Ocuphire recently completed a Phase 3 (1^st) registration trial in RM (NCT04620213), and a Phase 2 trial in presbyopia (NCT04675151). 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.

Ocuphire Contacts

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

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

FAQ

What is the recent development in Ocuphire Pharma's Medical Advisory Board?

Ocuphire Pharma has appointed six new key opinion leaders to its Medical Advisory Board to enhance its clinical expertise and support its drug development efforts.

Who are the new members of Ocuphire Pharma's Medical Advisory Board?

New members include David Brown, David Lally, Y. Ralph Chu, James Katz, Mitchell A. Jackson, and Douglas Devries, all recognized experts in ophthalmology.

What impact will the new KOLs have on Ocuphire Pharma?

The new KOLs are expected to enhance clinical trial strategies, regulatory submissions, and broaden market opportunities for Ocuphire's lead products.

What are Ocuphire Pharma's lead product candidates?

Ocuphire's lead product candidates include Nyxol for mydriasis and presbyopia, and APX3330 for diabetic eye diseases.