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.
However, in August, the FDA ordered Alpharetta, Ga.-based Clearside to provide stability data on its new manufacturing process for Xipere’s triamcinolone acetonide suspension, which at the time pushed the timeline on the agency’s decision into next year.
Last week, Clearside said it received a complete response letter from the FDA stating that the agency found no efficacy issues and would not request more studies. However, the CRL did include a new request for additional data on clinical use of Clearside’s SCS Microinjector delivery system.
Clearside said it expects to address the recommendations in the CRL in a manner that would allow the company to resubmit its NDA in the first quarter of 2020, according to the filing.
The company also plans to request a meeting with the FDA to discuss a way to go forward with the CRL’s recommendations. Finally, Clearside said it intends to enter into advanced discussions with potential out-licensing partners for Xipere.
Shares of CLSD were down -1.7% at 81¢ per share in midday trading today.