• Ocuphire Expands Medical Advisory Board with Seven New KOLs and Strengthens Leadership Team

    来源: Nasdaq GlobeNewswire / 29 9月 2022 07:00:01   America/Chicago

    FARMINGTON HILLS, Mich., Sept. 29, 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 has appointed seven new Key Opinion Leaders (KOLs) across retina, cornea/refractive, and medical optometry to its Medical Advisory Board (MAB). In addition, Ronil Patel, M.S. has been promoted to Vice President, Business Development and Market Strategy.

    “The collective and extensive clinical experience on landmark ophthalmic trials over decades is central to this accomplished group of advisors being added to our MAB. Their guidance will be invaluable as we advance our late-stage candidates Nyxol and APX3330 through important clinical and regulatory milestones across our targeted indications,” said Mina Sooch, Founder and CEO of Ocuphire Pharma. “In addition, Ronil has established himself as very capable strategist, and I am confident he will continue to position Ocuphire for significant growth in his new role as Vice President, Business Development and Market Strategy.”

    Jay Pepose, M.D., Ph.D., Ocuphire’s Chief Medical Advisor continued, “Ocuphire is one of few companies with a diverse medical advisory board spanning across retinal surgeons, refractive surgeons, and medical optometrists. We are honored to have these ophthalmic leaders join our existing MAB, now totaling over 20, which represents a distinguished roster of global thought leaders. I look forward to leveraging the expertise of the expanded group who will guide us as we develop and commercialize innovative treatments for front and back of the eye conditions.”

    The new members of the Medical Advisory Board are:

    Vitreoretinal Surgeons

    • Anat Loewenstein, M.D. is Chair of the Department of Ophthalmology at Tel Aviv Sourasky Medical Center and Professor of Ophthalmology and Vice Dean at Tel Aviv University. Dr. Loewenstein earned her medical degree at the Hebrew University in Jerusalem, completed residency in ophthalmology at the Tel Aviv Medical Center, and completed a fellowship in vitreoretinal disease at the Wilmer Eye Institute at St. Johns Hopkins Hospital.
    • Caroline Baumal, M.D. is a Professor of Ophthalmology at Tufts Medical Center and co-director of the retina service and medical retina fellowship at New England Eye Center in Boston, MA. Dr. Baumal earned her medical degree and completed ophthalmology residency at the University of Toronto Medical School. She completed fellowships in Medical Retina and Lasers research at the New England Eye Center and in Vitreoretinal Diseases at Wills Eye Hospital.

    Cornea and Refractive Surgeons

    • Zaina Al-Mohtaseb, M.D. is a cornea, cataract, and refractive surgeon at Whitsett Vision Group in Texas and chairs the ASCRS Young Eye Surgeons Clinical Committee. Dr. Al-Mohtaseb earned her medical degree and ophthalmology residency at Baylor College of Medicine, and a fellowship in cornea/external disease, cataract and refractive surgery at the University of Miami’s Bascom Palmer Eye Institute.
    • Inder Paul Singh, M.D. is President of The Eye Centers of Racine and Kenosha in Wisconsin. Dr. Singh earned his medical degree from Finch University of Health Sciences/The Chicago Medical School, completed residency in ophthalmology at Cook County Hospital, and completed fellowship in glaucoma at Duke University.

    Medical Optometrists

    • Leslie O’Dell, O.D. is the medical director of Medical Optometry America in Pennsylvania. Dr. O’Dell is a Fellow of the American Academy of Optometry (AAO) and one of six Tear Film and Ocular Surface Society Global Ambassadors for the United States. She also serves as the Secretary for Intrepid Eye Society. Dr. O’Dell graduated from the Salus College of Optometry and completed residency at the Baltimore VA hospital.
    • Selina McGee, O.D. is Founder, Chief Optometrist, Executive and Visionary at BeSpoke Vision in Oklahoma and Adjunct Assistant Professor at the Northeastern State University College of Optometry. She is a Fellow of the AAO and Vice President of the Intrepid Eye Society. Dr. McGee earned her optometry degree from Northeastern State University College of Optometry.
    • Justin Schweitzer, O.D. is the optometric externship director at Vance Thompson Vision in Sioux Falls, South Dakota. He is a Fellow of the American Academy of Optometry, Adjunct Clinical Professor at the Illinois College of Optometry and Kentucky College of Optometry. He serves as current president of the South Dakota Optometric Society. Dr. Schweitzer earned his optometry degree from Pacific University College of Optometry and completed residency at Vance Thompson Vision.

    In addition to the appointment of new MAB members, Ocuphire announced the promotion of Ronil Patel, M.S, to Vice President, Business Development and Market Strategy. Mr. Patel has over 15 years of experience in medical research, biotech R&D, and pharmaceutical business development. He has worked in ophthalmology since 2012 and has managed multiple clinical stage assets that achieved FDA approval and are currently being commercialized in the US. Mr. Patel’s global business development experience has involved in-licensing clinical stage assets for development in the US and several biotech exits. He holds a Master of Science degree with specialization in Biotechnology from Florida Institute of Technology.

    About Ocuphire Pharma

    Ocuphire is a publicly traded (Nasdaq: OCUP), clinical-stage, ophthalmic biopharmaceutical company focused on developing and commercializing small-molecule therapies for the treatment of refractive and retinal eye disorders.

    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). Nyxol has been studied in 12 completed clinical trials, with positive data reported from the MIRA-2 and MIRA-3 registration trials and the MIRA-4 pediatric safety trial for the treatment of RM. Ocuphire also reported positive top-line data from the VEGA-1 Phase 2 trial of Nyxol for treatment of presbyopia, which evaluated both Nyxol as a single agent and Nyxol with low dose pilocarpine (“LDP”) 0.4% as adjunctive therapy. The Company announced positive top-line results from the LYNX-1 Phase 3 trial of Nyxol for night vision disturbances (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). APX3330 has been studied in 11 Phase 1 and 2 trials. The Company announced the completion of last patient last visit in late August with top-line results expected in 4Q22.

    Please visit www.clinicaltrials.gov to learn more about Ocuphire’s ongoing APX3330 Phase 2b trial in DR/DME ZETA-1 (NCT04692688) and completed Nyxol trials: Phase 3 registration trial in NVD LYNX-1 (NCT04638660), Phase 3 registration trials in RM MIRA-2 (NCT04620213) and MIRA-3 (NCT05134974), MIRA-4 Phase 3 pediatric safety study (NCT05223478), and Phase 2 trial in presbyopia VEGA-1 (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 clinical and regulatory milestones for Ocuphire’s indications, business strategy and potential growth, and commercialization of Ocuphire’s product candidates. 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


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