Bausch and Clearside Biomedical announce FDA approval of Xipere

Bausch and Clearside Biomedical yesterday announced that the US Food and Drug Administration (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.

“With this FDA approval, Xipere is the first and only therapy available in the United States that utilises 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. The utilisation of the suprachoroidal space provides targetted delivery and compartmentalisation of medication,” said Joseph C Papa, Chairman and CEO, Bausch Health.

He also said, “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.”

Adding to it, George Lasezkay, PharmD, JD, President and CEO, Clearside, said, “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, targetted approach. With this approval, we begin a new era in delivering therapies to the back of the eye. 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. 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 targetted delivery of therapeutic agents to the retina and choroid, Bausch notified in a statement.

“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, 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.

He added, “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.”

The statement also said that the clinical programme for Xipere included the Phase-III trial (Peachtree), a phase-III, multi-center, non-interventional extension study (Magnolia), and an open-label safety trial (Azalea).

The FDA approval of Xipere was based on results from Peachtree, a randomised, multi-centre, double-masked, sham-controlled phase-III 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 (Best Corrected Visual Acuity) primary endpoint, it added.