Clearside Biomedical recently announced that additional data from PEACHTREE, the company’s pivotal phase 3 trial of Xipere (formerly suprachoroidal CLS-TA) in patients with uveitic macular edema, were presented by Rahul N. Khurana, MD, Vitreoretinal Surgeon at Northern California Retina Vitreous Associates, Clinical Associate Professor in Ophthalmology at UCSF Medical Center, and a principal investigator for PEACHTREE.
At the American Academy of Ophthalmology meeting, Dr. Khurana shared Xipere’s efficacy data in resolving uveitic inflammation for the first time at a scientific congress. Dr. Khurana also presented new analyses of resolution of clinically significant vitreous haze, as well as the mean change from baseline in best corrected visual acuity (BCVA) in patients with uveitis in each anatomical location, providing further support for the clinical profile of Xipere in the potential treatment of uveitic macular edema.
Resolution of Signs of Uveitis
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%, respectively, of patients in the control arm. Resolution was defined as achieving a score of zero on the applicable SUN scale, implying no measureable 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 company news release. “These additional data add to my confidence that Xipere holds promise for my patients with uveitic macular edema.”
Change in BCVA Across Anatomical Locations of Uveitis
Dr. Khurana also presented an analysis of the mean change in BCVA, from baseline at week 24 from each anatomical location of uveitis: anterior, intermediate, posterior, and panuveitis.
“Unlike current therapies, which have shown efficacy in certain locations of uveitis, such as anterior or posterior segment uveitis, patients treated with Xipere in the PEACHTREE trial achieved visual improvement across all anatomical locations of uveitis. This serves to further differentiate the impressive clinical profile of Xipere,” said Dr. Khurana.
PEACHTREE, a randomized, masked, sham-controlled phase 3 trial, enrolled 160 patients with macular edema associated with noninfectious uveitis, comparing Xipere dosed every 12 weeks to sham control.
The PEACHTREE trial met its primary endpoint at 24 weeks, with 47% of patients in the Xipere arm gaining at least 15 ETDRS letters in BCVA from baseline, compared to 16% of patients in the sham control arm (P<0.001). All key secondary and additional endpoints of the PEACHTREE trial were also achieved.