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Re: SurgeGuy2.0 post# 17

Tuesday, 10/13/2020 2:29:04 PM

Tuesday, October 13, 2020 2:29:04 PM

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Company: Kala Pharmaceuticals Inc (NASDAQ: KALA)
Type of Application: NDA
Candidate: Eysuvis
Indication: Dry eye disease
Date: Oct. 30
Eysuvis, or loteprednol etabonate ophthalmic suspension, is being evaluated for the short-term treatment of the signs and symptoms of dry eye disease.

Kala's original Eysuvis NDA was handed down a complete response letter in August 2019, with the FDA seeking positive data from an additional clinical trial. Following positive results from the STRIDE 3 Phase 3 trial, the company resubmitted the NDA in April. The company communicated FDA's acceptance of the resubmitted application on May 26.
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