LAVAL, Quebec and ALPHARETTA, Ga., Jan.
28, 2020 /CNW/ -- Bausch Health Companies Inc.
(NYSE/TSX: BHC) ("Bausch Health") and Bausch + Lomb, its leading
global eye health business, and 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 that Ophthalmology, the peer-reviewed journal of the
American Academy of Ophthalmology, has published results from the
randomized, controlled, double-masked Phase 3 clinical trial
(PEACHTREE study) of XIPERETM (triamcinolone acetonide
suprachoroidal injectable suspension), an investigational therapy
with a proposed indication of treatment of macular edema associated
with uveitis.1
"Macular edema is the leading cause of vision loss in patients
with uveitis," said Steven Yeh,
M.D., lead author and principal investigator for the PEACHTREE
study, and M. Louise Simpson Associate professor of ophthalmology,
Emory Eye Center. "The efficacy and safety data from the PEACHTREE
Phase 3 trial showed that delivery of XIPERE via suprachoroidal
administration, an alternative technique for delivering ocular
therapies, may facilitate more targeted delivery of therapeutic
agents to the retina and choroid. Targeted drug delivery via the
suprachoroidal space may also limit corticosteroid exposure to the
anterior segment with the potential to decrease adverse events,
such as cataracts, intraocular pressure elevation and exacerbation
of glaucoma, that can commonly arise from other local
corticosteroid delivery techniques."
The data demonstrated that patients with noninfectious uveitis
in the XIPERE study arm experienced clinically significant
improvement in vision relative to the control arm, demonstrating
the potential efficacy of suprachoroidal injection of XIPERE for
the treatment of macular edema associated with uveitis. No
serious adverse events (AEs) considered by the investigators
related to treatment were reported.
"The publication of our positive Phase 3 XIPERE clinical trial
results is an important milestone for Clearside as it expands the
understanding of our suprachoroidal treatment approach," said
Thomas A. Ciulla, M.D., MBA, chief
medical officer, Clearside Biomedical. "We are coordinating closely
with Bausch Health, our exclusive licensee of XIPERE in
the United States and Canada, and are excited for the potential to
add this treatment option to the repertoire for retinal
specialists."
"We are encouraged by the results of these data as they
demonstrated clinically meaningful improvement in vision for nearly
half of the patients treated, further supporting the efficacy
profile of XIPERE," said Joseph C.
Papa, chairman and CEO, Bausch
Health. "We look forward to continuing to advance this
promising therapy with Clearside, and we are hopeful that, if
approved, we will quickly bring forward this potential new
treatment option for patients."
About the Phase 3 PEACHTREE Study
The PEACHTREE study was a randomized, controlled, masked, Phase 3
clinical trial that evaluated the safety and efficacy of XIPERE in
160 patients with macular edema associated with noninfectious
uveitis. Patients were randomized to receive XIPERE at baseline and
at 12 weeks versus control. The PEACHTREE study met its primary
endpoint, with 47 percent of patients in the XIPERE arm gaining at
least 15 letters in best corrected visual acuity from baseline at
week 24, compared to 16 percent of patients in the control arm
(p<0.001), using the standardized Early Treatment of Diabetic
Retinopathy Study scale (visual acuity testing). All key secondary
and additional endpoints of the PEACHTREE study were also achieved.
No serious AEs considered by the investigators to be related to
treatment were reported. Corticosteroid-associated AEs of elevated
intraocular pressure occurred in 11.5% and 15.6% of the XIPERE and
control groups, respectively. Cataract AE rates were comparable
(7.3% and 6.3%, respectively).
About XIPERE™
XIPERE™ (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 that is being investigated
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. An affiliate of Bausch Health acquired the exclusive license
for the commercialization and development of XIPERE in the
United States and Canada in October 2019.
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.
About Bausch + Lomb
Bausch + Lomb, the leading global eye
health business of Bausch Health Companies Inc., is solely focused
on helping people see. Its core businesses include over-the-counter
products, dietary supplements, eye care products, ophthalmic
pharmaceuticals, contact lenses, lens care products, ophthalmic
surgical devices and instruments. Bausch + Lomb develops,
manufactures and markets one of the most comprehensive product
portfolios in the industry, which is available in more than 100
countries. For more information, visit
www.bausch.com.
About Bausch Health
Bausch Health Companies Inc.
(NYSE/TSX: BHC) is a global company whose mission is to improve
people's lives with our health care products. We develop,
manufacture and market a range of pharmaceutical, medical device
and over-the-counter products, primarily in the therapeutic areas
of eye health, gastroenterology and dermatology. We are delivering
on our commitments as we build an innovative company dedicated to
advancing global health. More information can be found at
www.bauschhealth.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 potential approval of XIPERE for the treatment of macular edema
associated with uveitis, opportunities for expanding Clearside's
internal pipeline, and the potential benefits of XIPERE and the SCS
injection platform. 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 September
30, 2019, filed with the SEC on November 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.
Bausch Health Forward-looking Statements
This news
release may contain forward-looking statements, which may generally
be identified by the use of the words "anticipates," "expects,"
"intends," "plans," "should," "could," "would," "may," "believes,"
"estimates," "potential," "target," or "continue" and variations or
similar expressions. These statements are based upon the current
expectations and beliefs of Bausch Health management and are
subject to certain risks and uncertainties that could cause actual
results to differ materially from those described in the
forward-looking statements. These risks and uncertainties include,
but are not limited to, risks and uncertainties discussed in Bausch
Health's most recent annual or quarterly report and detailed from
time to time in Bausch Health's other filings with
the U.S. Securities and Exchange Commission and the
Canadian Securities Administrators, which factors are incorporated
herein by reference. Readers are cautioned not to place undue
reliance on any of these forward-looking statements. These
forward-looking statements speak only as of the date hereof. Bausch
Health undertakes no obligation to update any of these
forward-looking statements to reflect events or circumstances after
the date of this news release or to reflect actual outcomes, unless
required by law.
References:
1. Steven Y, et al. Efficacy and Safety of Suprachoroidal CLS-TA
for Macular Edema Secondary to Noninfectious Uveitis: Phase 3,
Randomized Trial. Ophthalmology. 2020:
doi:10.1016/j.ophtha.2020.01.006.
Any product/brand names are trademarks of the respective owners.
XIPERE is a trademark of Clearside Biomedical, Inc.
Investor
Contact:
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Media
Contact:
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Arthur
Shannon
|
Lainie
Keller
|
arthur.shannon@bauschhealth.com
|
lainie.keller@bauschhealth.com
|
(514)
856-3855
|
(908)
927-0617
|
(877) 281-6642 (toll
free)
|
|
|
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Clearside
Biomedical:
|
|
Jenny
Kobin
|
|
Remy
Bernarda
|
|
ir@clearsidebio.com
|
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(678)
430-8206
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SOURCE Bausch Health Companies Inc.; Clearside Biomedical,
Inc.