Miebo®
Perfluorohexyloctane 100% · ophthalmic solution
Dry Eye/OSD
Approved uses
Dry eye disease
1 drop QID in the affected eye(s)
OFF-LABELNot in the FDA label for this product
Lid wiper epitheliopathy
1 drop QID for 2 months (trial regimen)
RCT · n=52 · unmasked
Randomized, no-treatment-controlled study in 52 adults with symptomatic dry eye and a Korb lid wiper epitheliopathy score of 1.0 or greater: Korb and photographic LWE grades were significantly better than no treatment from week 2 onward, as were SPEED and symptom scores at 2 months, but the 0.5-unit or greater photographic improvement at 2 months reached significance in right eyes only (P=0.04). The authors state masked comparative trials are still needed.
Contraindications
History of hypersensitivity reaction to perfluorohexyloctane.
Available Forms100% perfluorohexyloctane ophthalmic solution, 3 mL fill in a multiple-dose 5 mL bottle
Mechanism of ActionSemifluorinated alkane (6 perfluorinated and 8 hydrogenated carbons) that spreads into a monolayer at the air-liquid interface of the tear film, a physical barrier expected to reduce evaporation rather than an anti-inflammatory action. The exact mechanism in dry eye disease is not known.
Warnings & Precautions
Contact lens wear: Not to be administered with lenses in place; remove before instillation and for at least 30 minutes after.
Common Side Effects
- Ocular: Blurred vision and conjunctival redness, each 1% to 3% across two randomized controlled trials (614 treated).
- Hypersensitivity: Most common adverse reaction in four premarketing studies (three open-label, n=127; one randomized, n=24).
- Systemic: None described in the label.
Pregnancy & LactationPregnancy: No adequate and well controlled studies in pregnant women. Oral dosing in rats produced no embryofetal toxicity or teratogenicity up to 162 times the recommended human ophthalmic dose; rabbits showed maternal toxicity, miscarriages, and reduced fetal weights at all doses tested (lowest 41 times), without fetal malformations.
Lactation: No data on presence in human milk, effects on the breastfed infant, or milk production.
Pediatric UseSafety and effectiveness below 18 years not established.