Bausch + Lomb and Clearside Biomedical Announce US Commercial Launch of Xipere

Bausch + Lomb announced the US commercial launch of Xipere (triamcinolone acetonide injectable suspension), the first and only therapy approved by the FDA for suprachoroidal use for the treatment of macular edema associated with uveitis.

"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" said Joseph C. Papa, chairman and CEO, Bausch Health. "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. 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"

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, PharmD., JD, 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, which provides exceptional access and high bioavailability to the posterior segment of the eye, has been well tolerated by patients," said Steven Yeh, MD, 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 important. I encourage eye care professionals to take advantage of the trainings being offered by Bausch + Lomb."

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.

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.