Ocuphire Pharma, Inc. (Nasdaq: OCUP), a clinical-stage ophthalmic
biopharmaceutical company focused on developing and commercializing
therapies for the treatment of several eye disorders, today
announced that it will host a key opinion leader (KOL) event on
Nyxol, its late-stage product candidate under development as a
potential new treatment option for reversing pharmacologically
induced mydriasis (dilation of pupil for eye exams).
The Webinar will feature a roundtable discussion among three
KOLs from across the spectrum of eye care providers - optometry,
ophthalmology, and retina:
- Paul M. Karpecki, O.D., F.A.A.O. – Cornea and Refractive
Optometrist, Kentucky Eye Institute
- Jay Pepose, M.D., Ph.D. – Cornea and Refractive Surgeon, Pepose
Vision Institute
- Peter Kaiser, M.D. – Vitreoretinal Surgeon, Cole Eye Institute,
Cleveland Clinic
Please register ahead of time for the Webinar on Wednesday, May
26, 2021 at 1:00 pm EDT using this link.
Drs. Karpecki, Pepose, and Kaiser will discuss the large unmet
need for a treatment to reverse approximately 100 million
pharmacological dilations that occur each year. Dr. Pepose will
present the positive Phase 3 results from the recently completed
pivotal MIRA-2 trial for Nyxol for the reversal of
pharmacologically induced mydriasis, which met its primary endpoint
and multiple secondary endpoints. The panel will also discuss the
pharmacological approaches that have been considered in the past,
how Nyxol has the potential to address an unmet medical need as
there are no commercial treatments currently available for reversal
of mydriasis, and how a reversal agent could benefit their clinical
practice and patients. An update will be provided on the reversal
of mydriasis program, including the remaining steps prior to NDA
submission and plans for commercialization. The KOLs and Ocuphire
management will be available to answer questions following the
panel discussion.
“There is a significant unmet need for patients with regards to
the reversal of mydriasis, an indication that currently lacks a
treatment. We are excited to hear from these experts who will
provide their clinical perspective on how Nyxol will benefit both
patients and physicians alike,” says Susan Benton, MBA, a 30-year
veteran of the ophthalmic pharmaceutical and device industry and a
director on Ocuphire’s Board. “As we plan our commercial strategy
for launch, it is critical to work closely with eye care
professionals who will play an important role in the adoption of
this potential new treatment option if approved by the FDA.”
About the KOLs
Paul M. Karpecki O.D.,
F.A.A.O. currently serves as Director of Cornea Services
for Kentucky Eye Institute in Lexington KY, Gaddie Eye Centers in
Louisville KY, and Center for Sight in Carmel IN. He is the Chief
Medical Editor for Review of Optometry, chairman of the NTT
Conferences and heads the journal’s clinical content. He is the
Medical Director for KEPLR Vision. He was appointed co-chair for
the previous two Tear Film and Ocular Surface Society (TFOS)
Symposia and served on the DEWS II Diagnostic Methodology
Committee. In 2017-2018 he completed a full year preceptorship in
advanced retinal disease at Retina Associates of Kentucky, one of
the top 20 retina programs in the country. He currently serves as
an Associate Professor at the Kentucky College of Optometry and on
the board of the charitable organization Optometry Giving Sight.
Dr. Karpecki received his Doctor of Optometry degree from Indiana
University and completed a Durrie Fellowship in Cornea &
Refractive Surgery in Kansas City in affiliation with the
Pennsylvania College of Optometry.
Jay Pepose, M.D., Ph.D. is a board-certified
ophthalmologist specializing in cataract, corneal, and refractive
surgery. He is the founder and an attending surgeon of Pepose
Vision Institute and Professor of Clinical Ophthalmology and Visual
Sciences at Washington University School of Medicine, where he held
the Bernard Becker Chair. An advisor and consultant to numerous
ophthalmic companies throughout the world, he has published
hundreds of peer reviewed articles, holds ophthalmology related
patents, and has been at the forefront of the industry's
evolutionary changes throughout his career. He is recipient of
the Lifetime Achievement Award from the American Academy of
Ophthalmology, the Cogan Award from the Association of Research in
Vision and Ophthalmology and has been elected to the American
Ophthalmological Society. Dr. Pepose is actively involved in
clinical research and has been the recipient of R-01 grant support
from the National Eye Institute. He has served as executive editor
of The American Journal of Ophthalmology, as well as on the
editorial board of Investigational Ophthalmology and Visual
Science, Cornea, and The Journal of Refractive Surgery. After
obtaining a Bachelor of Arts degree Magna Cum Laude with High
Honors in Biology along with a Master of Arts in Neurophysiology
from Brandeis University, Dr. Pepose completed the MD-PhD program
at UCLA School of Medicine as a Regent’s Scholar and was inducted
into the Alpha Omega Alpha Honor Medical Society. Dr. Pepose
received residency training in ophthalmology and the Distinguished
Alumnus Award from The Wilmer Institute of The Johns Hopkins
Hospital and fellowship training in cornea, external disease and
refractive surgery at Georgetown University Medical Center.
Peter K. Kaiser, M.D., is a clinical research
expert, serving as Study Chairman of 5 major, multi-center,
international clinical trials, and principal investigator in
numerous studies for Age-related Macular Degeneration, Diabetic
Retinopathy, and other retinal disorders. He is the founder and
director of the Digital Optical Coherence Tomography Reading Center
(DOCTR), Editor-in-Chief of Retinal Physician, Associate Editor of
International Ophthalmology Clinics, and serves on the editorial
boards of Retina, Retina Today, and Ocular Surgery News. He is a
National Institute of Health (NIH) funded investigator, leading a
team involved in the evaluation of vascular biology in age-related
macular degeneration and diabetic retinopathy. Dr. Kaiser serves on
numerous scientific advisory boards and addresses his research
interests as an invited speaker at national and international
conferences. He is a major contributor to the medical literature
having authored 7 textbooks and more than 250 peer-reviewed papers,
has been recognized by the American Academy of Ophthalmology and
American Society of Retina Specialists with Senior Achievement
Awards and is listed as one of the “Best Doctors in America.” Dr.
Kaiser graduated magna cum laude with Highest Honors from Harvard
College and Harvard Medical School. He completed an ophthalmology
residency at the Massachusetts Eye and Ear Infirmary, and a
vitreoretinal fellowship at Bascom Palmer Eye Institute before
joining the vitreoretinal department of the Cole Eye Institute,
Cleveland, Ohio.
About the Reversal of Mydriasis Market
Every year in the U.S., approximately 100 million eye exams are
performed that require dilation of the pupil (mydriasis) to examine
the back of the eye either for routine check-ups, disease
monitoring or surgical procedures. Depending on the individual and
the color of their eyes, the pharmacologically-induced dilation can
last anywhere from 6 to 24 hours. Dilated eyes have heightened
sensitivity to light and an inability to focus on near objects,
causing difficulty with reading, working, and driving.
Market research conducted by GlobalData surveyed several hundred
patients and eye care providers (optometrists and ophthalmologists)
about reversal of mydriasis (as well as Night Vision Disturbances
and Presbyopia). Over 65% of surveyed patients reported moderate to
severe negative impact of a dilated exam. This underscores the
potential value of the role of the investigational product
candidate Nyxol in improving comfort and daily function after pupil
dilation. Additionally, an estimated 45% of patients responded that
they would be very likely to request a dilation reversal drop, and
more than 40% of eye care providers would be likely to use a
reversal drop if such a treatment were commercially available.
About Nyxol
Ocuphire’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 dim light or night vision disturbances (NVD), reversal of
pharmacologically-induced mydriasis (RM), and presbyopia. Nyxol has
been studied in 8 clinical trials demonstrating a favorable safety
and tolerability profile. Ocuphire recently reported positive
top-line data for pivotal MIRA-2 Phase 3 trial for treatment of RM
in March 2021. Nyxol met its primary endpoint in more rapidly
reversing a dilated pupil back to its baseline diameter, as well as
multiple secondary endpoints in this 185-patient clinical trial.
Nyxol is also currently in Phase 2 for presbyopia with top-line
results expected Q2 2021, and in Phase 3 clinical development for
NVD with top-line results expected Q3 2021. Please
visit www.clinicaltrials.gov to learn more about
Ocuphire’s completed Phase 2 trials in RM, Glaucoma, and NVD,
recently completed Phase 3 registration trial in
RM (NCT04620213), and ongoing Phase 2 trial in presbyopia
(NCT04675151) and Phase 3 registration trial in
NVD (NCT04638660).
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 – Nyxol and APX3330 – targeting
front and back of the eye indications. 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 in key global markets. For more information,
please 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 Ocuphire’s product candidates, results
of ongoing and future clinical trials, and commercialization and
market opportunities. 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
Advisorscdavis@lifescieadvisors.com
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