Clearside Biomedical (NSDQ:CLSD) said today that the FDA ordered the company to provide stability data on its new manufacturing process for triamcinolone acetonide suspension, pushing the timeline on the agency’s decision into next year.
Alpharetta, Ga.-based Clearside’s Xipere device is a suprachoroidal injection designed for the treatment of macular edema associated with uveitis.
Clearside said the formulation of the TA suspension is unchanged, but the FDA wants data on its new manufacturing process to compare with data from the original NDA submission. The requested data doesn’t involve or affect its SCS microinjector platform, the company said.
A complete response letter from the FDA is expected on or before Oct. 19, Clearside said, and it intends to resubmit the NDA with the updated data in the first quarter of 2020. The company expects the FDA to review the NDA within six months of the resubmission.
“After a productive meeting with the FDA, the agency has provided clear guidance on the chemistry, manufacturing & controls data to be included in the NDA resubmission,” CEO George Lasezkay said in prepared remarks. “We believe this is primarily a timing issue, since our stability data from previously manufactured batches have been consistent and predictable and we have every reason to believe this will continue to be the case. We will complete these efforts as quickly as possible as we work towards approval of Xipere as a potential treatment option for patients suffering from uveitic macular edema. Discussions with potential Xipere out-licensing partners remain ongoing. We continue to expect that we will have sufficient resources to fund operations into the third quarter of 2020, without relying on any partnership-related payments that we might gain through Xipere partnering or R&D collaboration agreements.”
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 an NDA the following December.
CLSD shares were off -0.6% to $0.69 apiece in early morning trading today.