New data has been published in The British Journal of Ophthalmology related to the clinical development program of Clearside Biomedical’s Xipere, an investigational treatment with a proposed indication of macular edema associated with noninfectious uveitis.
Data from AZALEA, an open label safety trial, found suprachoroidal (SC) triamcinolone acetonide injectable suspension (CLS-TA) injections in patients with noninfectious uveitis (NIU), with or without macular edema, showed no new safety signals in this study over 24 weeks.
Data published from the phase 3 PEACHTREE trial and MAGNOLIA extension study found that over 48 weeks, the median time to rescue therapy for patients with macular edema due to NIU treated with suprachoroidal CLS-TA was 257 days versus 55.5 days for those in the sham control group. Additionally, 50% of patients treated with CLS-TA who participated in the MAGNOLIA study did not require rescue therapy for up to 9 months after the second treatment, and of those patients, there was a mean gain of 12.1 letters and mean reduction in retinal central subfield thickness (CST) of 178.1 µm through week 48.
No serious adverse events related to study treatment were observed.
“Suprachoroidal administration is a potential alternative technique for delivering ocular therapies that may facilitate more targeted delivery and increased durability of therapeutic agents to the retina and choroid,” Dr. Christopher Ryan Henry, MD, of Retina Consultants of Texas who served as the AZALEA study principal investigator and contributed to the research for the PEACHTREE and MAGNOLIA studies, said in a statement from Clearside Biomedical. “The publication of these data in The British Journal of Ophthalmology provides further information on this investigational therapeutic approach. We are pleased to share this information with our colleagues in the medical community.”