Clearside Biomedical has announced additional data from PEACHTREE, the company’s pivotal phase 3 trial of Xipere (formerly suprachoroidal CLS-TA) in patients with uveitic macular edema. These results were presented at the AAO annual meeting by Rahul N. Khurana, MD, vitreoretinal surgeon at Northern California Retina Vitreous Associates and a principal PEACHTREE investigator. In the PEACHTREE trial, at week 24, 40.9% of patients with baseline scores of 2+ vitreous haze, based on the Standardization of Uveitis Nomenclature (SUN) scale, experienced resolution in the Xipere arm, compared to 0% of patients in the control arm who underwent a sham procedure. Additionally, in the Xipere arm, 68% of patients with any baseline level of vitreous haze, 72% of patients with anterior chamber cell inflammation and 74% of patients with anterior chamber flare had their inflammation resolve, compared to 23%, 17%, and 20% for the sham arm. Resolution was defined as achieving a score of 0 on the applicable SUN scale, implying that no measurable inflammation was present.
“The PEACHTREE trial was the first pivotal phase 3 clinical trial to demonstrate improvement in vision for patients with uveitic macular edema, and patients experiencing resolution of uveitis is an important outcome for uveitis specialists and for their patients,” Dr. Khurana said in a news release.