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Biotech Stocks Facing FDA Decision In October 2019

Clearside Biomedical
Clearside Biomedical

The FDA decision on Clearside Biomedical Inc’s (CLSD) New Drug Application for XIPERE for the treatment of macular edema associated with uveitis is expected on October 19, 2019.

Xipere is a proprietary suprachoroidal injectable suspension of the corticosteroid triamcinolone acetonide formulated for administration to the back of the eye using a specially-designed SCS microinjector.

Suprachoroidal space (SCS) is located between the choroid and the outer protective layer of the eye, known as the sclera.

On August 22, 2019, 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.

As a result of this request, Clearside expects to receive a Complete Response Letter from the FDA for XIPERE. The Company plans to re-submit the NDA in the first quarter of 2020 with the requested stability data.

If approved, XIPERE would be the first therapy for uveitic macular edema.

CLSD closed Friday’s (Sep.27, 2019) trading at $0.65, down 3.21%.