Bausch + Lomb and Clearside Biomedical Announce the U.S. Commercial Launch of XIPERE® (Triamcinolone Acetonide Injectable Suspension) For Suprachoroidal Use for the Treatment of Macular Edema Associated with Uveitis
XIPERE® is the First and Only FDA-Approved Therapy for Delivery via Suprachoroidal Injection
"XIPERE® is the first and only therapy available in
Macular edema is the buildup of fluid in the macula, which causes retinal swelling and distorted vision, and if left untreated, may lead to permanent vision loss.4 XIPERE® is approved for the treatment of macular edema associated with uveitis via suprachoroidal administration using the proprietary SCS Microinjector® developed by Clearside.
"The commercialization of XIPERE® is an exciting step forward for the treatment of macular edema associated with uveitis, and also for increasing education and recognition of the suprachroidal space as a highly effective administration route for back-of-the-eye therapies," said George Lasezkay, Pharm.D., J.D., president and CEO, Clearside. "As the first commercial product developed by Clearside and the first therapy approved for macular edema associated with uveitis, XIPERE® represents our commitment to delivering much needed treatments for those living with serious retinal diseases."
Suprachoroidal administration is an innovative approach for delivering ocular therapies that may facilitate more targeted delivery of therapeutic agents to the retina and choroid. The suprachoroidal space is located between the sclera and the choroid, which expands upon injection, allowing delivery of XIPERE® to the posterior structures of the eye.5
"Suprachoroidal administration, which provides exceptional access and high bioavailability to the posterior segment of the eye, has been well tolerated by patients," said
Physicians interested in attending a XIPERE® training session can register at https://www.xipere.com/hcp/xipere-training. For more information on XIPERE®, visit www.xipere.com.
Important Safety Information about XIPERE®
XIPERE® (triamcinolone acetonide injectable suspension) is a corticosteroid used to treat macular edema associated with an eye disease called uveitis.
IMPORTANT SAFETY INFORMATION
- Your eye doctor will monitor you for elevated eye pressure following treatment and manage it with medication or surgery if required.
- See your eye doctor right away if your eyes become red, sensitive to light or painful, or if you notice changes in vision.
- XIPERE is not appropriate for use in patients with eye infections. It should be used with caution in patients with a history of herpes simplex in the eye.
- XIPERE is not appropriate for use in patients with a known allergy to triamcinolone acetonide or any other components of this product.
- Use of corticosteroids such as XIPERE may produce cataracts, increased eye pressure and glaucoma, and may increase the likelihood of eye infections.
- Patients being treated with XIPERE for extended periods of time will be monitored for problems with the body's hormonal system, which controls the ability to respond to stress.
- In clinical studies, the most common eye-related side effects were increased eye pressure and eye pain. Other side effects included cataract, floaters or flashes of light, injection site pain, burst blood vessels, reduced or blurred vision, dry eye, light sensitivity, redness, infection, swelling, watery eyes, eye or eyelid irritation, bumps on the eyelid, itchy eyes, and drooping eyelid.
The most common non-eye-related side effect was headache.
- Corticosteroids should be used during pregnancy or nursing only if the potential benefit justifies the potential risk to the fetus or nursing infant. Talk to your eye doctor.
To report SUSPECTED ADVERSE REACTIONS, contact Bausch + Lomb at 1-800-321-4576 or FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.
Please click here for full Prescribing Information
About Bausch + Lomb
Bausch + Lomb, a leading global eye health business of
Clearside Biomedical 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 commercial launch of XIPERE. 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, uncertainties regarding the COVID-19 pandemic and other risks and uncertainties that are described in Clearside's Annual Report on Form 10-K for the year ended
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," "hopes," "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 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, the risks and uncertainties discussed in
- XIPERE® [prescribing information]. Alpharetta, GA:
Clearside Biomedical, Inc.; 2021.
- Massa, H., Pipis, S. Y., Adewoyin, T., Vergados, A.,
Patra, S., & Panos, G. D. (2019). Macular edema associated with non-infectious uveitis: pathophysiology, etiology, prevalence, impact and management challenges. Clinical Ophthalmology ( Auckland, N.Z.), 13, 1761–1777. https://doi.org/10.2147/OPTH.S180580
- Thorne JE, Suhler E, Skup M, et al. Prevalence of Noninfectious Uveitis in
the United States: A Claims-Based Analysis. JAMA Ophthalmol. 2016;134:1237-1245. American Academy of Ophthalmology. Retrieved from https://www.aao.org/eye-health/diseases/what-is-macular-edema . Accessed August 20, 2021.
- Chiang B, Jung JH, Prausnitz MR. The suprachoroidal space as a route of administration to the posterior segment of the eye. Adv Drug Deliv Rev. 2018;126:58-66.
XIPERE®, SCS® and SCS Microinjector® are trademarks of Clearside
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