Ocuphire Pharma, Inc. (Nasdaq: OCUP), a clinical-stage
ophthalmic biopharmaceutical company focused on developing and
commercializing therapies for the treatment of several eye
disorders, announced today that it has completed
enrollment in the VEGA-1 Phase 2 clinical trial (NCT04675151)
evaluating the safety and efficacy of a combination kit of Nyxol®
and low-dose pilocarpine in presbyopia. VEGA-1 successfully
recruited 150 subjects in just under 3 months.
“Achieving our enrollment completion target for the VEGA-1 trial
is yet another important milestone in our Nyxol program and tracks
for top-line results by the end of June,” said Mina Sooch, MBA,
President and CEO of Ocuphire Pharma. “Nyxol has the potential to
address multiple unmet needs initially with the large market
opportunity in reversal of mydriasis supported by our recent
positive Phase 3 data results and then adding this very large
presbyopia market opportunity that is estimated at over $5 billion
in the US alone. We are excited to develop Nyxol with low-dose
pilocarpine as a potential option for the growing number of
presbyopic patients and to also realize commercial synergies if
products are approved given the common targeted optometrists and
ophthalmologists.”
The global prevalence of presbyopia is estimated to be 2
billion. An estimated 120 million Americans live with presbyopia, a
large prevalence that is expected to exceed 150 million by 2034. To
assist with their near vision deficiencies, individuals with
presbyopia use reading glasses and contact lenses, and in some
cases undergo surgical interventions. However, there are currently
no approved drug therapies for presbyopia. As there are several
drawbacks to reading glasses and contact lenses, including
inconvenience, eye strain, and night vision disturbances, eye drops
are increasingly being explored as an alternative. As for payment,
presbyopia corrective devices have been mostly out-of-pocket cash
pay by patients.
Marguerite McDonald, M.D., F.A.C.S, Clinical Professor of
Ophthalmology at the NYU Langone Medical Center and Ocuphire
Medical Advisory Board member, stated, “Presbyopia is a condition
that affects nearly everyone over the age of 40. Many patients
reliant on reading glasses and contact lenses desire more
flexibility and convenience and continually request alternatives or
a complementary choice. Development of eyedrop treatments for
Presbyopia has recently become very active, led by Allergan having
recently submitted an NDA for this indication. There is room for
many options given the large unmet need, and I am encouraged by
Nyxol eye drops in combination with low-dose pilocarpine
eye drops as a differentiated solution that works both on the
iris dilator and sphincter muscles. This combination product should
allow for moderate unopposed pupil constriction and provide the
ability to see both at near and at distance without the
side-effects such as brow ache, headache, blurry vision, and loss
of distance night vision associated with the use of higher doses of
pilocarpine.”
Based on a GlobalData market research report, 69% of patients
would consider an eye drop as an alternative to reading glasses.
Importantly, over 70% of patients indicated that they wear reading
glasses in the morning, afternoon, and evening, suggesting that
patients desire a solution with durability. Over 50% of responders
also indicated that using drops 2 to 4 times per day would be
moderately to very convenient to them. In addition, 66% of surveyed
eyecare providers indicated interest in a Nyxol and low-dose
pilocarpine product profile as a potential therapeutic alternative
to reading glasses.
About VEGA-1 Phase 2 Clinical Trial
The VEGA-1 clinical trial is designed to evaluate the
efficacy and safety of Nyxol in combination with low-dose
pilocarpine compared to placebo in presbyopic subjects. A
total of 150 subjects (planned target was 140 to 152)
have been enrolled at 17 investigational sites in the US from
mid-February to mid-May this year. The Phase 2 trial is randomized,
double-masked, placebo-controlled with 4 treatment arms. At the
first visit, subjects are randomized to receive either Nyxol or
placebo drops that are instilled at home near bedtime for 3 to 4
days prior to Visit 2; at Visit 2 subjects then receive either
low-dose pilocarpine or no treatment with efficacy and safety
measurements collected at multiple timepoints through 6 hours. The
primary endpoint is the percentage of subjects with
≥ 15 letters of improvement in photopic binocular near vision (i.e.
distance-corrected near visually acuity, DCNVA) at 1 hour on Visit
2 for Nyxol + low-dose pilocarpine arm compared to placebo alone
arm. Secondary endpoints at multiple timepoints include
improvements of 3 lines of DCNVA without any loss of distance
vision, pupil diameter, and improvements of DCNVA at 1 and 2 lines
compared to placebo as well as to each Nyxol and low-dose
pilocarpine alone. Top-line results are expected by
the end of Q2 2021.
Ocuphire collaborated closely with Oculos Development Services,
a Tampa, Florida based clinical research organization and a
subsidiary of Iuvo BioScience, on the launch and execution of the
VEGA-1 trial. “We are pleased by the rapid enrollment in
this Phase 2 trial, which speaks to the unmet need of an eye
drop to benefit vision correction for patients with presbyopia. We
thank our investigators, clinical coordinators, staff, and
subjects for their support and ease of trial execution at 17
sites across the U.S.,” said Chuck Slonim, MD, Chief Medical
Officer and Medical Monitor of Oculos Development
Services.
For more information about the VEGA-1 Phase 2 trial design and
its U.S. clinical sites, please
visit www.clinicaltrials.gov (NCT04675151).
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 dim light or night vision disturbances
(NVD), reversal of pharmacologically-induced mydriasis (RM), and
presbyopia, and has been studied in 8 clinical trials including the
recently completed Phase 3 trial in RM. Ocuphire reported positive
topline data in March 2021 for MIRA-2, a Phase 3 FDA registration
study for treatment of RM. Nyxol is also currently in Phase 3
clinical development for NVD and in Phase 2 for presbyopia.
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
completed Phase 2 trials, recently completed Phase 3 registration
trial (NCT04620213), ongoing Phase 3 registration
trial (NCT04638660), Phase 2 trial in presbyopia
(NCT04675151), and Phase 2 trial in DR/DME (NCT04692688). 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, and (ix) the success and
timing of commercialization of any of Ocuphire’s product
candidates. 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@lifescieadvisors.com
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