FDA Approves New Method for Macular Edema Treatment

 

Today, the U.S. Food and Drug Administration (FDA) greenlit Xipere, the first suprachoroidal injectable medicine for macular edema associated with uveitis, co-developed by Clearside Biomedical and Bausch & Lomb.

Xipere (triamcinolone acetonide injectable suspension) was approved for suprachoroidal use for the treatment of macular edema associated with uveitis, a form of eye inflammation. Suprachoroidal injection is a method designed for targeted delivery of drugs to the retina and choroid. 

George Lasezkay, president and chief executive officer of Georgia-basedClearside, called the suprachoroidal space an “untapped frontier” in eye health. The approval of Xipere launches a new era in delivering therapies to the back of the eye. 

Macular edema is the buildup of fluid in the macula, which causes retinal swelling and distorted vision. If left untreated, the condition may lead to permanent vision loss. Xipere harnesses the capabilities of the proprietary SCS Microinjector technology developed by Clearside. The SCS Microinjector allows 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, Clearside said in its announcement.  

The companies believe that delivering drugs to the suprachoroidal space can potentially reduce adverse events, including cataracts, intraocular pressure elevation and exacerbation of glaucoma.

“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,” Lasezkay said in a statement. 

Joseph C. Papa, chairman and CEO of Bausch Health, the parent company of Bausch + Lomb, noted that Xipere is the first and only therapeutic that uses the suprachoroidal space to treat patients suffering from macular edema associated with uveitis. That disorder is the leading cause of vision loss in people with uveitis. He also noted that the suprachoroidal space allows for targeted delivery of therapeutics and facilitates the compartmentalization of medication.

Xipere was approved by the FDA based on data from the pivotal Phase III PEACHTREE study. In that study, 47% of patients who were treated with Xipere achieved at least a 15-letter Best Corrected Visual Acuity improvement after 24 weeks, which was the primary endpoint. The 47% was statistically significant. Other data that also demonstrated the efficacy of Xipere was seen in the MAGNOLIA and AZALEA studies.

Xipere is expected to be available for use in the United States in the first quarter of 2022.