Perfluorohexyloctane

INDICATIONS AND USAGE 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. ( 1 )

DOSAGE AND ADMINISTRATION Instill one drop of MIEBO four times daily into each eye. ( 2.1 ) 2.1 Recommended Dosage Instill one drop of MIEBO four times daily into affected eye(s). Contact lenses should be removed prior to and for at least 30 minutes after the administration of MIEBO. 2.2 Administration Instructions Step 1. Remove the cap from eye drop bottle. Step 2. Holding the bottle upright, gently squeeze the bottle. Step 3. While squeezing, turn the bottle upside down and release the pressure (drawing air into the bottle). Step 4. Keeping the bottle upside down, place the bottle above your eye and squeeze it again to release a drop into your eye. Repeat steps 1 - 4 for the second affected eye. Step 2. Step 3. Step 4.

WARNINGS AND PRECAUTIONS 5.1 Use with Contact Lenses MIEBO should not be administered while wearing contact lenses. Advise patients that contact lenses should be removed prior to and for at least 30 minutes after administration of MIEBO.

CONTRAINDICATIONS Hypersensitivity. ( 4.1 ) 4.1 Hypersensitivity MIEBO is contraindicated in patients with a history of hypersensitivity reaction to perfluorohexyloctane [see Adverse Reactions ( 6.1 )] .

ADVERSE REACTIONS Most common ocular adverse reaction was blurred vision. Blurred vision was reported in less than 4% of individuals. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Bausch & Lomb Incorporated at 1-800-553-5340 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In patients with DED, 614 patients received at least one dose of MIEBO in two randomized controlled clinical trials across 68 sites in the United States. The most common ocular adverse reaction was blurred vision. Blurred vision and conjunctival redness were reported in 1-3% of individuals. In four premarketing studies (three open-label [n=127], one randomized [n=24 treated with at least one dose of perfluorohexyloctane]) the most common adverse reaction was hypersensitivity.

Mechanism of Action Perfluorohexyloctane, a semifluorinated alkane, contains 6 perfluorinated carbon atoms and 8 hydrogenated carbon atoms. Perfluorohexyloctane forms a monolayer at the air-liquid interface of the tear film which can be expected to reduce evaporation. The exact mechanism of action for MIEBO in DED is not known.