“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
The new members of the
Vitreoretinal Surgeons
Anat Loewenstein , M.D. is Chair of theDepartment of Ophthalmology atTel Aviv Sourasky Medical Center and Professor of Ophthalmology and Vice Dean atTel Aviv University .Dr. Loewenstein earned her medical degree at theHebrew University inJerusalem , completed residency in ophthalmology at theTel Aviv Medical Center , and completed a fellowship in vitreoretinal disease at theWilmer Eye Institute atSt. Johns Hopkins Hospital .Caroline Baumal , M.D. is a Professor of Ophthalmology atTufts Medical Center and co-director of the retina service and medical retina fellowship atNew England Eye Center inBoston, MA. Dr. Baumal earned her medical degree and completed ophthalmology residency at theUniversity of Toronto Medical School . She completed fellowships in Medical Retina and Lasers research at theNew England Eye Center and in Vitreoretinal Diseases atWills Eye Hospital .
Cornea and Refractive Surgeons
Zaina Al-Mohtaseb , M.D. is a cornea, cataract, and refractive surgeon atWhitsett Vision Group inTexas and chairs the ASCRS Young Eye Surgeons Clinical Committee.Dr. Al-Mohtaseb earned her medical degree and ophthalmology residency atBaylor College of Medicine , and a fellowship in cornea/external disease, cataract and refractive surgery at the University of Miami’sBascom Palmer Eye Institute .Inder Paul Singh , M.D. is President ofThe Eye Centers of Racine andKenosha inWisconsin .Dr. Singh earned his medical degree fromFinch University ofHealth Sciences/The Chicago Medical School , completed residency in ophthalmology atCook County Hospital , and completed fellowship in glaucoma atDuke 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 theAmerican Academy of Optometry (AAO) and one of six Tear Film and Ocular Surface Society Global Ambassadors forthe United States . She also serves as the Secretary forIntrepid Eye Society . Dr. O’Dell graduated from theSalus College of Optometry and completed residency at theBaltimore VA hospital. Selina McGee , O.D. is Founder, Chief Optometrist, Executive and Visionary at BeSpoke Vision inOklahoma and Adjunct Assistant Professor at theNortheastern State University College of Optometry . She is a Fellow of the AAO and Vice President of theIntrepid Eye Society .Dr. McGee earned her optometry degree fromNortheastern State University College of Optometry .Justin Schweitzer , O.D. is the optometric externship director atVance Thompson Vision inSioux Falls, South Dakota . He is a Fellow of theAmerican Academy of Optometry , Adjunct Clinical Professor at theIllinois College of Optometry andKentucky College of Optometry . He serves as current president of theSouth Dakota Optometric Society .Dr. Schweitzer earned his optometry degree fromPacific University College of Optometry and completed residency atVance Thompson Vision .
In addition to the appointment of new MAB members, Ocuphire announced the promotion of
About
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
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
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
Ocuphire Contacts
ir@ocuphire.com
www.ocuphire.com
cdavis@lifesciadvisors.com
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