Skip to main content

Miebo FDA Approval History

Last updated by Judith Stewart, BPharm on May 20, 2023.

FDA Approved: Yes (First approved May 18, 2023)
Brand name: Miebo
Generic name: perfluorohexyloctane
Dosage form: Ophthalmic Solution
Previous Name: NOV03
Company: Bausch & Lomb Inc.
Treatment for: Dry Eye Disease

Miebo (perfluorohexyloctane) is a semifluorinated alkane indicated for treatment of the signs and symptoms of dry eye disease.

Development timeline for Miebo

May 18, 2023Approval FDA Approves Miebo (perfluorohexyloctane) Ophthalmic Solution for the Treatment of the Signs and Symptoms of Dry Eye Disease
Sep  6, 2022Bausch + Lomb and Novaliq Announce U.S. FDA Filing Acceptance for Investigational Treatment NOV03 (Perfluorohexyloctane)
Jul  7, 2022Bausch + Lomb and Novaliq Announce Submission of New Drug Application for Investigational Treatment NOV03 (Perfluorohexyloctane)

Further information

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