Clearside Biomedical announced an update regarding the company’s new drug application (NDA) for Xipere (triamcinolone acetonide suprachoroidal injectable suspension) with the FDA.
In a meeting this week, the FDA’s Office of Pharmaceutical Quality (OPQ) requested that Clearside provide stability data for the triamcinolone acetonide (TA) suspension produced utilizing an enhanced manufacturing process implemented by the company. The formulation of the TA suspension has not changed; however, OPQ requested the data to verify the comparability of the stability profiles of the batches made with the enhanced manufacturing process with that of the batches originally submitted as part of the NDA. The requested data does not relate to or affect the SCS Microinjector platform.
As a result of this request, Clearside expects to receive a complete response letter from the FDA on or before its October 19, 2019 PDUFA (Prescription Drug User Fee Act) goal date. The company plans to re-submit the NDA in the first quarter of 2020 with the requested stability data.
“After a productive meeting with the FDA, the agency has provided clear guidance on the Chemistry, Manufacturing, and Controls (CMC) data to be included in the NDA resubmission,” George Lasezkay, PharmD, JD, Chief Executive Officer, said in a company news release. “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.”
Dr. Lasezkay continued, “This request does not impact in any way the SCS Microinjector platform targeting the delivery of therapeutic agents to the suprachoroidal space. We continue to focus on building our internal R&D initiatives and advancing discussions with potential partners interested in accessing the suprachoroidal space.”
Clearside believes the FDA will review the NDA within 6 months of the receipt of the resubmission. The above information is subject to the final meeting minutes and anticipated receipt of a Complete Response Letter from the FDA.