Clearside Biomedical (NSDQ:CLSD) last week said that the FDA found no efficacy issues with its Xipere drug-delivery technology and will not ask for further clinical efficacy studies.
The Xipere device is a suprachoroidal injection designed for the treatment of macular edema associated with uveitis. In October 2018, Clearside touted data from a Phase III pivotal trial, which reported that 40% of people using Xipere experienced resolution of uveitis, compared to 0% in the control. The company submitted a new drug application the following December, and that NDA was accepted in February.
Get the full story at our sister site, Drug Delivery Business News.