Ocugen Announces Completion of 50% of Enrollment of its Phase 3 Clinical Trial for ocular GVHD
December 09 2019 - 8:29AM
Ocugen, Inc., (NASDAQ: OCGN), ), a clinical-stage biopharmaceutical
company focused on discovering, developing and commercializing a
pipeline of innovative therapies that address rare and underserved
eye diseases, today announced that it has completed 50% of
enrollment of its Phase 3 clinical trial for OCU300 for patients
with ocular Graft Versus Host Disease (oGVHD). Ocugen is the
first and only company to receive Orphan Drug Designation for a
product candidate designed to treat oGVHD and is the first company
to conduct a Phase 3 clinical trial in patients with this disease.
The ongoing Phase 3 trial is a double-masked,
placebo-controlled 84-day trial, in which 60 patients will be
randomized in a 2:1 ratio to receive either OCU300 (brimonidine
0.18% nanoemulsion) or a placebo. The purpose of the trial is
to evaluate the safety and efficacy of brimonidine tartrate
nanoemulsion eye drop solution in the treatment of ocular redness
and ocular discomfort in patients with oGVHD. The trial has
co-primary endpoints of ocular discomfort based on a 10-point
visual analog scale and ocular redness based on a 100-point
validated bulbar redness score.
Daniel Jorgensen, M.D., M.P.H., M.B.A., Chief
Medical Officer of Ocugen, stated, “The achievement of 50%
enrollment is a key milestone towards the completion of this
important Phase 3 trial. oGVHD is a severe ocular autoimmune
disease that occurs in up to 60% of allogeneic bone marrow
transplant patients. There is no approved therapy for this
debilitating condition, and it is our belief that OCU300 will
provide needed relief for patients suffering from this disease.”
Dr. Jorgensen continued, “We remain on track to report topline
results from this trial in the second half of 2020.”
About OCU300 OCU300 is in pivotal
stage clinical development for treating ocular discomfort and
ocular redness in patients with the debilitating autoimmune
condition called ocular Graft Versus Host Disease (oGVHD), which
develops in many patients following an allogeneic bone marrow
transplant. It is the only product candidate to be granted Orphan
Drug Designation for this indication from the U.S. Food and Drug
Administration (FDA), and it consists of an improved 0.18%
ophthalmic nanoemulsion of brimonidine tartrate, an FDA-approved
drug with established safety for ocular use, enabling Ocugen to
develop OCU300 under the accelerated 505(b)(2) regulatory pathway.
Ocugen's patented OcuNanoE™ technology is designed to enhance
efficacy by prolonging retention of this potent anti-inflammatory
drug on the eye surface. In addition, it allows OCU300 to be
sterile filtered into single-use vials as preservative-free
nanoemulsion, thereby eliminating potentially irritating effects of
preservatives.
About Ocugen, Inc. Ocugen, Inc. is
a clinical-stage biopharmaceutical company focused on discovering,
developing and commercializing a pipeline of innovative therapies
that address rare and underserved eye diseases. The Company offers
a robust and diversified ophthalmology portfolio that includes
novel gene therapies, biologics, and small molecules and targets a
broad range of high-need retinal and ocular surface diseases.
Ocugen is leveraging its groundbreaking modifier gene therapy
platform to address genetically diverse inherited retinal disorders
(IRDs) and dry age-related macular degeneration (AMD), based on
nuclear hormone receptor genes NR2E3 (OCU400) and RORA (OCU410),
respectively. OCU400 has received two Orphan Drug
Designations targeting two distinct IRDs. Ocugen is also
developing novel biologic therapies for wet-AMD, diabetic macular
edema and diabetic retinopathy (OCU200), as well as for retinitis
pigmentosa (OCU100). The Company’s late-stage Phase 3 trial
for patients with oGVHD(OCU300) leverages Ocugen’s patented
OcuNanoE – Ocugen’s ONE Platform™ technology to enhance the
efficacy of topical ophthalmic therapeutics. OCU300 is the first
and only product candidate to receive Orphan Drug Designation for
the treatment of oGVHD, providing certain regulatory and economic
benefits. For more information, please visit www.ocugen.com.
Cautionary Note on Forward-Looking
StatementsThis press release contains forward-looking
statements within the meaning of The Private Securities Litigation
Reform Act of 1995, which are subject to risks and
uncertainties. We may, in some cases, use terms such as “predicts,”
“believes,” “potential,” “proposed,” “continue,” “estimates,”
“anticipates,” “expects,” “plans,” “intends,” “may,” “could,”
“might,” “will,” “should” or other words that convey uncertainty of
future events or outcomes to identify these forward-looking
statements. Such statements are subject to numerous important
factors, risks and uncertainties that may cause actual events or
results to differ materially from the Company’s current
expectations. These and other risks and uncertainties are more
fully described in our periodic filings with the Securities and
Exchange Commission (the “SEC”), including the risk factors
described in the section entitled “Risk Factors”
in the Company’s Quarterly Report on Form 10-Q filed with
the SEC on November 12, 2019. Any forward-looking statements
that the Company makes in this press release speak only as of the
date of this press release. The Company assumes no obligation to
update forward-looking statements contained in this press
release whether as a result of new information, future events
or otherwise, after the date of this press release.
Corporate Contact:
Ocugen, Inc.
Kelly Beck
kelly.beck@ocugen.com
+1 484-328-4698
Media Contact:
LaVoieHealthScience
Emmie Twombly
etwombly@lavoiehealthscience.com
+1 857-389-6042
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