Clearside Biomedical Provides New Drug Application Update for XIPEREᵀᴹ (triamcinolone acetonide suprachoroidal injectable...
22 Agosto 2019 - 6:05AM
Clearside Biomedical, Inc. (Nasdaq:CLSD), a biopharmaceutical
company dedicated to developing and delivering treatments that
restore and preserve vision for people with serious back of the eye
diseases, announced today an update regarding the
Company’s 505(b)(2) New Drug Application (NDA) for XIPERETM
(triamcinolone acetonide suprachoroidal injectable suspension) with
the U.S. Food and Drug Administration (FDA).
In a meeting this week, the FDA’s Office of
Pharmaceutical Quality (OPQ) requested that Clearside provide
stability data for the triamcinolone acetonide (TA) suspension
produced utilizing an enhanced manufacturing process implemented by
the Company. The formulation of the TA suspension has not changed;
however, OPQ requested the data to verify the comparability of the
stability profiles of the batches made with the enhanced
manufacturing process with that of the batches originally submitted
as part of the NDA. The requested data does not relate to or affect
the SCS Microinjector™ platform.
As a result of this request, Clearside expects
to receive a Complete Response Letter from the FDA on or before its
October 19, 2019 PDUFA (Prescription Drug User Fee Act) goal date.
The Company plans to re-submit the NDA in the first quarter of 2020
with the requested stability data.
“After a productive meeting with the FDA, the
Agency has provided clear guidance on the Chemistry, Manufacturing,
and Controls (CMC) data to be included in the NDA resubmission,”
stated George Lasezkay, Pharm.D., J.D., Chief Executive Officer.
“We believe this is primarily a timing issue since our stability
data from previously manufactured batches have been consistent and
predictable, and we have every reason to believe this will continue
to be the case. We will complete these efforts as quickly as
possible as we work towards approval of XIPERE as a potential
treatment option for patients suffering from uveitic macular edema.
Discussions with potential XIPERE out-licensing partners remain
ongoing. We continue to expect that we will have sufficient
resources to fund operations into the third quarter of 2020,
without relying on any partnership-related payments that we might
gain through XIPERE partnering or R&D collaboration
agreements.”
Dr. Lasezkay continued, “This request does not
impact in any way the SCS Microinjector platform targeting the
delivery of therapeutic agents to the suprachoroidal space. We
continue to focus on building our internal R&D initiatives and
advancing discussions with potential partners interested in
accessing the suprachoroidal space.”
Clearside believes the FDA will review the NDA
within six months of the receipt of the resubmission. The above
information is subject to the final meeting minutes and anticipated
receipt of a Complete Response Letter from the FDA.
About XIPERE™
XIPERETM (triamcinolone acetonide suprachoroidal
injectable suspension), formerly known as CLS-TA, is a proprietary
suspension of the corticosteroid triamcinolone acetonide formulated
for administration to the back of the eye for the treatment of
macular edema associated with uveitis. Clearside’s patented
technology is designed to deliver drug to the suprachoroidal space
located between the choroid and the outer protective layer of the
eye, known as the sclera. Suprachoroidal injection enables the
rapid and adequate dispersion of medicine to the back of the eye,
offering the potential for the medicine to act longer and minimize
harm to the surrounding healthy parts of the eye, thus potentially
providing advantageous and sustained efficacy with a favorable
safety profile.
About Clearside Biomedical
Clearside Biomedical, Inc. is a
biopharmaceutical company dedicated to developing and delivering
treatments that restore and preserve vision for people with serious
back of the eye diseases. Clearside’s proprietary SCS
Microinjector™ targeting the suprachoroidal space (SCS) offers
unique access to the macula, retina and choroid where
sight-threatening disease often occurs. The Company’s SCS injection
platform is an inherently flexible, in-office, non-surgical
procedure, intended to provide targeted delivery to the site of
disease and to work with both established and new formulations of
medications, as well as future therapeutic innovations such as gene
therapy. For more information, please visit
www.clearsidebio.com.
Cautionary Note Regarding
Forward-Looking Statements
Any statements contained in this press release
that do not describe historical facts may constitute
forward-looking statements as that term is defined in the Private
Securities Litigation Reform Act of 1995. These statements may be
identified by words such as “believe”, “expect”, “may”, “plan”,
“potential”, “will”, and similar expressions, and are based on
Clearside’s current beliefs and expectations. These forward-looking
statements include statements regarding the timing for resubmitting
the XIPERE NDA, the receipt of a Complete Response Letter from the
FDA, the potential out-licensing of XIPERE and the economic terms
such a license might include, opportunities for expanding
Clearside’s internal pipeline and entering into other licensing
arrangements, the potential benefits of XIPERE and the SCS
injection platform and the period of time over which Clearside
expects its current financial resources to be sufficient to fund
its planned operations. These statements involve risks and
uncertainties that could cause actual results to differ materially
from those reflected in such statements. Risks and uncertainties
that may cause actual results to differ materially include
uncertainties inherent in the conduct of clinical trials,
Clearside’s reliance on third parties over which it may not always
have full control, and other risks and uncertainties that are
described in Clearside’s Annual Report on Form 10-K for the year
ended December 31, 2018, filed with the U.S. Securities and
Exchange Commission (“SEC”) on March 15, 2019, Clearside’s
Quarterly Report on Form 10-Q for the quarter ended June 30, 2019,
filed with the SEC on August 8, 2019, and Clearside’s other
Periodic Reports filed with the SEC. Any forward-looking statements
speak only as of the date of this press release and are based on
information available to Clearside as of the date of this release,
and Clearside assumes no obligation to, and does not intend to,
update any forward-looking statements, whether as a result of new
information, future events or otherwise.
Investor and Media Contacts: Jenny Kobin Remy
Bernarda ir@clearsidebio.com(678) 430-8206
Source: Clearside Biomedical, Inc.
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