Treats dry eye disease (DED). NDA 216675, held by Bausch And Lomb Inc. Perfluorohexyloctane.
As of Nov 14, 2026, NDA 216675 (Miebo), held by Bausch And Lomb Inc, was first approved by FDA on May 18, 2023, with 1 approved supplement and 0 published complete response letters.
MIEBO (perfluorohexyloctane ophthalmic solution) is indicated for the treatment of the signs and symptoms of dry eye disease (DED). MIEBO (perfluorohexyloctane ophthalmic solution) is a semifluorinated alkane indicated for treatment of the signs and symptoms of dry eye disease.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 18, 2023 | Original applicationNew molecular entity · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Miebo1.338GM/ML · solution/drops;ophthalmic | Perfluorohexyloctane | RxReference drug |
| Oct 21, 2025 | Supplement 9Labeling · Standard review | Approved | |
| May 18, 2023 | Original applicationNew molecular entity · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
