Bausch + Lomb and Clearside Biomedical Announce FDA Approval of Xipere for the Treatment of Macular Edema Associated with Uveitis

Bausch + Lomb and Clearside Biomedical announced that the FDA has approved Xipere (triamcinolone acetonide injectable suspension) for suprachoroidal use for the treatment of macular edema associated with uveitis, a form of eye inflammation.¹

"With this FDA approval, XIPERE is the first and only therapy available in the United States that utilizes the suprachoroidal space to treat patients suffering from macular edema associated with uveitis, which is the leading cause of vision loss in people with uveitis.² The utilization of the suprachoroidal space provides targeted delivery and compartmentalization of medication," Joseph C. Papa, chairman and CEO, Bausch Health, said in a company news release. "The approval of Xipere exemplifies our commitment to bringing innovative new options to help patients improve their treatment journey. We expect to make Xipere available during the first quarter of 2022."

"The suprachoroidal space is an untapped frontier in eye health. We are proud to be the pioneers in treating serious retinal diseases by implementing this novel, targeted approach. With this approval, we begin a new era in delivering therapies to the back of the eye," said George Lasezkay, PharmD, JD, president and CEO, Clearside. "Xipere is the first commercial product developed by Clearside, the first product approved for injection into the suprachoroidal space and the first therapy approved for macular edema associated with uveitis. Our unique approach now has the potential to positively impact this patient population, which previously had no other treatment options approved for this indication."

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.³ Xipere is designed to treat macular edema associated with uveitis via suprachoroidal administration using the proprietary SCS Microinjector developed by Clearside. Suprachoroidal administration is an innovative technique for delivering ocular therapies that may facilitate more targeted delivery of therapeutic agents to the retina and choroid.

The SCS Microinjector offers unique access to the back of the eye where sight-threatening disease often occurs. It is designed to provide targeted and compartmentalized delivery and higher proportions of absorption relative to intravitreal injection (IVT).⁴ Targeted drug delivery via the suprachoroidal space (SCS) may also limit corticosteroid exposure to the anterior segment⁵ with the potential to reduce the risk of certain adverse events, such as cataracts, intraocular pressure elevation and exacerbation of glaucoma, that are commonly associated with local delivery techniques.⁶

"The safety and efficacy data of Xipere was demonstrated in multiple clinical studies and its unique suprachoroidal administration approach provides exceptional access and high bioavailability to the posterior segment of the eye," 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 (PEACHTREE) pivotal study. "With the approval of Xipere, eye care professionals now have a new and innovative treatment option for their patients with macular edema associated with uveitis."

XIPERE Clinical Data

The clinical program for Xipere included the pivotal phase 3 trial (PEACHTREE), a phase 3, multicenter, non-interventional extension study (MAGNOLIA), and an open-label safety trial (AZALEA).

The FDA approval of Xipere was based on results from PEACHTREE, a randomized, multicenter, double-masked, sham-controlled phase 3 clinical trial of 160 patients with macular edema associated with uveitis. Xipere is the first and only uveitic macular edema treatment to demonstrate clinical efficacy with a BCVA primary endpoint.

The primary efficacy endpoint was the proportion of patients in whom BCVA had improved by at least 15 letters from baseline after 24 weeks of follow-up. In the trial, a statistically significantly greater proportion of patients treated with Xipere (47%) achieved at least a 15-letter improvement in BCVA than patients in the control arm (16%, P< 0.01) at Week 24.⁷

The most common adverse reactions reported by greater than or equal to 10% of patients and at a rate greater than control included elevated intraocular pressure and eye pain.

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. American Academy of Ophthalmology. Retrieved from https://www.aao.org/eye-health/diseases/what-is-macular-edema. Accessed August 20, 2021.
4. Viral S. Kansara, Leroy W. Muya, Thomas A. Ciulla; Evaluation of Long-Lasting Potential of Suprachoroidal Axitinib Suspension Via Ocular and Systemic Disposition in Rabbits. Trans. Vis. Sci. Tech. 2021;10(7):19. doi: https://doi.org/10.1167/tvst.10.7.19.
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. doi:10.1016/j.addr.2018.03.001.
6. Moisseiev E, Loewenstein A, Yiu G. The suprachoroidal space: from potential space to a space with potential. Clin Ophthalmol. 2016;10:173-178. Published 2016 Jan 25. doi:10.2147/OPTH.S89784.
7. Yeh, S., Khurana, R. N., Shah, M., Henry, C. R., Wang, R. C., Kissner, J. M., Ciulla, T. A., & Noronha, G. (2020). Efficacy and safety of suprachoroidal CLS-TA for macular edema secondary to noninfectious uveitis. Ophthalmology, 127(7), 948–955. https://doi.org/10.1016/j.ophtha.2020.01.006.