Bausch + Lomb announces XIPERE commercial launch in US

Bausch + Lomb and Clearside Biomedical Inc. are rolling out the new therapeutic, approved by the FDA for suprachoroidal use for the treatment of macular edema associated with uveitis.

Bausch + Lomb and Clearside Biomedical Inc. this week announced the US commercial launch of XIPERE (triamcinolone acetonide injectable suspension), the first and only therapy approved by the U.S. Food and Drug Administration (FDA) for suprachoroidal use for the treatment of macular edema associated with uveitis, a form of eye inflammation.1

According to Joseph C. Papa, chairman and CEO, Bausch Health, XIPERE is the first and only therapy available in the United States that utilizes the suprachoroidal space to treat patients who struggle with macular edema associated with uveitis, which is the leading cause of vision loss in people with uveitis.2

“Throughout the past several months, we have been training eye care professionals all over the country on how to properly administer XIPERE using its unique suprachoroidal injection method, which enables targeted delivery and compartmentalization of the medication,” Papa said in a statement. “We are pleased that XIPERE is now broadly available as a new and unique treatment option for the 300,000 Americans who suffer from this serious condition."3

According to the companies, 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," George Lasezkay, Pharm.D., JD, president and CEO, Clearside, said in a statement. "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

Steven Yeh, MD noted in a statement that suprachoroidal administration, which provides exceptional access and high bioavailability to the posterior segment of the eye, has been well tolerated by patients. He is a professor of Ophthalmology and director of Retinal Disease and Uveitis, Stanley M. Truhlsen Eye Institute, University of Nebraska Medical Center, and principal investigator for the XIPERE Phase 3 pivotal study.

“This administration technique is unlike traditional intraocular administration, and therefore, training for how to properly inject patients with this new medicine is importan,” he said. “I encourage eye care professionals to take advantage of the trainings being offered by Bausch + Lomb."

References
1. XIPERE [prescribing information]. Alpharetta, GA: Clearside Biomedical, Inc.; 2021.
2. 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
3. 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.
4. American Academy of Ophthalmology. Retrieved from https://www.aao.org/eye-health/diseases/what-is-macular-edema . Accessed August 20, 2021.
5. 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.