Xipere, the first product for injection into the suprachoroidal space to treat macular oedema associated with uveitis, has been granted US Food and Drug Administration (FDA) approval.
Developed by Bausch + Lomb, Xipere (triamcinolone acetonide) is delivered to the back of the eye using Clearside Biomedical’s SCS Microinjector to provide compartmentalised delivery and better absorption, according to a joint statement by the two companies.
FDA approval followed Xipere’s phase-3 clinical trial of 160 patients, in whom best-corrected visual acuity (BCVA) had improved by at least 15 letters from baseline and a statistically significantly greater proportion of treated patients (47%) achieved at least a 15-letter improvement in BCVA than patients in the control arm (16%, p< 0.01) after 24 weeks of follow-up, according to the companies.
