Ocugen Provides an Update on its COVAXIN™ Pediatric (2-18) Emergency Use Authorization (EUA) Request
04 März 2022 - 1:01PM
Ocugen, Inc. (NASDAQ: OCGN), a clinical-stage biopharmaceutical
company focused on discovering, developing, and commercializing
gene therapies to cure blindness diseases and developing a vaccine
to save lives from COVID-19, today announced that the U.S. Food and
Drug Administration (FDA), at this time, has declined to issue an
EUA for COVAXIN™ for active immunization to prevent COVID-19 caused
by SARS-CoV-2 in individuals 2 to 18 years of age. Ocugen intends
to continue working with FDA to evaluate the regulatory pathway for
the pediatric use of COVAXIN™.
About Ocugen,
Inc.Ocugen, Inc. is a clinical-stage
biopharmaceutical company focused on discovering, developing, and
commercializing gene therapies to cure blindness diseases and
developing a vaccine to save lives from COVID-19. Our breakthrough
modifier gene therapy platform has the potential to treat multiple
retinal diseases with one drug – “one to many” and our novel
biologic product candidate aims to offer better therapy to patients
with underserved diseases such as wet age-related macular
degeneration, diabetic macular edema and diabetic retinopathy. We
are co-developing Bharat Biotech’s COVAXIN™ vaccine candidate for
COVID-19 in the U.S. and Canadian markets. 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. Such forward-looking statements within
this press release include, without limitation, our intent to work
with the FDA with respect to the regulatory pathway for COVAXIN. 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 our current expectations, such as market and other
conditions. 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 quarterly and annual reports
that we file with the SEC. Any forward-looking statements that we
make in this press release speak only as of the date of this press
release. Except as required by law, we assume 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.
Ocugen Contact:Ken
InchaustiHead, Investor Relations &
CommunicationsIR@Ocugen.com
Please submit investor-related inquiries to: IR@ocugen.com
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