Ocuphire’s APX3330 for Retinal Diseases to be Presented at the 2021 Association for Research in Vision and Ophthalmology (A...
April 22 2021 - 08:00AM
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 data from pre-clinical studies and pharmacokinetic
modeling of the Company’s proprietary APX3330 drug candidate will
be presented on Sunday, May 2, 2021 during the upcoming Association
for Research in Vision and Ophthalmology (ARVO) virtual Annual
Meeting, May 1 – 7, 2021.
Details of the abstract and presentation are as follows:
Title: Oral APX3330 treatment reduces
L-CNV lesions in preclinical mouse model and confirms Phase 2
DR/DME clinical dose with sufficient distribution to human retina
using PBPK modelingSession: Diabetic
RetinopathyPresentation Type: Paper
PresentationDate: 11:15 AM – 12:45 PM EDT on
Sunday, May 2
On Saturday, May 1, 2021 at 7:00 AM ET, the virtual
presentations will be available on demand to registered attendees
of the ARVO Annual Meeting. Ocuphire plans to post the APX3330
abstract presentation to Ocuphire’s website under Posters and
Publications.
Data from this pre-clinical study showed that oral
administration of APX3330 was effective in reducing laser-induced
choroidal neovascularization (L-CNV) in a mouse model, which is a
widely validated model for studying antiangiogenic therapies.
Additionally, new data will be presented from PBPK modeling that
confirmed the dosing strategy for the ongoing ZETA-1 Phase 2 trial
in patients with diabetic retinopathy (DR) and diabetic macular
edema (DME).
Dr. Mark R. Kelley, Professor in the Department of Pediatrics
and Glick Eye Institute at Indiana University School of Medicine,
founder of the APX3330 program, and member of Ocuphire’s Medical
Advisory Board stated, “We are very pleased to share new data on
the PBPK modeling results of APX3330 which quantitatively predict
the amount of drug that would be reaching the retina. At present,
DR patients are less frequently treated with anti-VEGF intravitreal
injections, so we are excited to initially develop APX3330 as a
potential oral treatment option for DR patients.”
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 on March 15, 2021 for MIRA-2 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 has entered Phase 2
clinical development for 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
Advisorscdavis@lifescieadvisors.com
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