Clearside Biomedical Inc CLSD shares entered penny stock territory Thursday after the company issued an update on what transpired at a meeting with the FDA regarding the new drug application for Xipere.
What Happened
In a meeting this week, the FDA's Office of Pharmaceutical Quality sought stability data for the triamcinolone acetonide, or TA, suspension produced utilizing an enhanced manufacturing process enacted by the company, Clearside said Thursday.
The company submitted an NDA through the 505(b)(2) pathway seeking approval for Xipere, chemically triamcinolone acetonide suprachoroidal injectable suspension.
The agency accepted the application Feb. 20 and assigned a PDUFA date of Oct. 19.
Xipere is being evaluated for treating patients with macular edema associated with uveitis.
Clearside said the formulation of the TA suspension hasn't changed, and it said the FDA's request may have to do with verification of 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 company said it expects a complete response letter from the FDA on or before the PDUFA action date. The company plans a resubmission in the first quarter of 2020 with the requested stability data.
"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," Clearside CEO George Lasezkay said in a statement.
What's Next
The company also said it would have sufficient resources to fund operations into the third quarter of 2020 without having to rely on any partnership-related payments expected from Xipere or R&D collaboration agreements.
Clearside said it expects the FDA to issue its verdict within six months of the receipt of the resubmission.
The proposed plan is subject to the final meeting minutes and the FDA actually issuing a CRL, the company said.
Clearside shares were falling by 44.75% to 70 cents at the time of publication Thursday.
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