Dr. Merrill’s shared the extension study results in a presentation entitled “Suprachoroidal CLS-TA Maintains Efficacy Outcomes Through 48-weeks in Uveitic Macular Edema subjects: Results of the MAGNOLIA Phase 3 Extension Study.” MAGNOLIA followed 28 of the 96 patients who were in the XIPERE treatment arm of PEACHTREE, across 22 of the clinical sites utilized in PEACHTREE, for six additional months without treatment to better understand XIPERE’s long-term clinical profile.
“In MAGNOLIA, 50% of XIPERE-treated subjects maintained efficacy through 36 additional weeks after their second suprachoroidal injection of XIPERE, without requiring additional treatment,” stated Dr. Merrill. “These data are important to clinicians as we seek new options to reduce the treatment burden on our patients while maintaining the vision gains offered by the treatment, as seen in the PEACHTREE trial.”
“In December, we submitted a new drug application to the
The most common adverse events seen in the MAGNOLIA trial included cataracts and increases in intraocular pressure and were consistent with previous trials of XIPERE. No serious adverse events were reported.
MAGNOLIA was a non-interventional, prospective observational extension study of the Phase 3 PEACHTREE study, designed to characterize the clinical profile of XIPERE through 48-weeks. In MAGNOLIA, 28 subjects who were treated with XIPERE at baseline and week 12 and followed through week 24 in the PEACHTREE study were followed for an additional 24 weeks. The mean time to rescue therapy in this subset of patients was over 9 months from their second injection in the PEACHTREE study. No serious adverse events related to study treatment were observed.
XIPERE, Clearside’s first investigational treatment to reach New Drug Application (“NDA”) submission to the
PEACHTREE, a randomized, masked, sham-controlled Phase 3 trial, enrolled 160 patients with macular edema associated with non-infectious uveitis, and compared XIPERE dosed every 12 weeks to sham control.
The PEACHTREE trial met its primary endpoint, with 47% of patients in the XIPERE arm gaining at least 15 letters in best corrected visual acuity, as measured using the Early Treatment of Diabetic Retinopathy Study scale, from baseline at week 24, 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.
Uveitis, a set of inflammatory conditions affecting the eye, is one the world’s leading causes of blindness. Uveitis occurs in about 350,000 patients in the United States and is typically found in both eyes. The uveitis market is expected to grow by 2024 to nearly
Cautionary Note Regarding Forward-Looking Statements
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “believe”, “expect”, “may”, “plan”, “potential”, “will”, and similar expressions, and are based on Clearside’s current beliefs and expectations. These forward-looking statements include expectations regarding the clinical development of Clearside’s product candidates, the potential attributes and benefits of Clearside’s product candidates, and the potential commercialization of XIPERE in