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Eysuvis FDA Approval History

Last updated by Judith Stewart, BPharm on Jan 19, 2021.

FDA Approved: Yes (First approved October 26, 2020)
Brand name: Eysuvis
Generic name: loteprednol etabonate
Dosage form: Ophthalmic Suspension
Company: Kala Pharmaceuticals, Inc.
Treatment for: Dry Eye Disease

Eysuvis (loteprednol etabonate) is an ophthalmic corticosteroid formulation for the temporary relief of signs and symptoms of dry eye disease.

Development timeline for Eysuvis

DateArticle
Oct 27, 2020Approval FDA Approves Eysuvis (loteprednol etabonate) Ophthalmic Suspension for the Short-Term Treatment of the Signs and Symptoms of Dry Eye Disease
May 26, 2020Kala Pharmaceuticals Announces FDA Acceptance of New Drug Application for Eysuvis for Dry Eye Disease
May  4, 2020Kala Pharmaceuticals Resubmits New Drug Application for Eysuvis for Dry Eye Disease
Jan 15, 2020Kala Pharmaceuticals Announces Completion of Enrollment of STRIDE 3 Trial for Eysuvis (KPI-121 0.25%) for Dry Eye Disease
Aug  8, 2019Kala Pharmaceuticals Receives FDA Complete Response Letter for KPI-121 0.25% NDA and Plans to Respond with Data From STRIDE 3 Trial
Dec 26, 2018Kala Pharmaceuticals Announces New Drug Application for KPI-121 0.25% for Dry Eye Disease Has Been Accepted for Review by the U.S. Food and Drug Administration
Oct 16, 2018Kala Pharmaceuticals Submits New Drug Application to U.S. Food and Drug Administration for KPI-121 0.25% for Dry Eye Disease

See also

Eysuvis (loteprednol etabonate) Consumer information

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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