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Biotech Stocks Facing FDA Decision In October 2020

Kala Pharmaceuticals
Kala Pharmaceuticals

Kala Pharmaceuticals Inc. (KALA) which failed to secure approval for EYSUVIS last August, hopes for second-time lucky with this investigational eye treatment.

EYSUVIS, or KPI-121 0.25%, which contains the corticosteroid Loteprednol etabonate, is proposed for the temporary relief of signs and symptoms of dry eye disease and a decision is expected by October 30, 2020.

The FDA when denying approval to EYSUVIS in its first attempt last August had requested the company to submit efficacy data from an additional clinical trial if it had to be approved.

Dry eye disease is a chronic, episodic, multifactorial disease affecting the tears and ocular surface and can involve tear film instability, inflammation, discomfort, visual disturbance and ocular surface damage.

The onset of action with the current prescribed dry eye disease therapies like Novartis’ Xiidra and Allergan’s Restasis takes weeks or months while that with EYSUVIS is rapid, say just within two weeks, according to the company.

Kala Pharma already markets another formulation of loteprednol etabonate ophthalmic suspension by the name Inveltys, which was approved last year, to treat pain and swelling following eye surgery.

KALA closed Friday’s (Sep.25, 2020) trading at $7.78, up $3.32%.