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A tolerability profile you’ve been looking for1-3
In 2 pivotal clinical studies with >600 patients treated with MIEBO1:
No incidences of serious ocular adverse events (AEs)2,3
Most AEs were considered mild
Low discontinuation rate due to AEs2-4
Discontinuation rate for MIEBO was comparable to control (pooled: 0.2% vs 0.5%; GOBI: 0.3% vs 1.0%; MOJAVE: 0% vs 0%)
Low rate of burning or stinging2-4
The pooled incidence of instillation site pain, such as burning or stinging, was 0.5% (GOBI: 1.0%; MOJAVE: 0%)
One ocular AE with an incidence of ≥2%1-4
The most common ocular AE was blurred vision, which was mostly mild and transient. Blurred vision (pooled: 2.1%; GOBI: 3.0%; MOJAVE: 1.3%) and conjunctival redness (pooled: 0.8%; GOBI: 0%; MOJAVE: 1.3%) were reported in 1%-3% of individuals
In the KALAHARI long-term extension study,
tolerability results were consistent with pivotal trials5
The primary safety endpoint was the incidence of ocular and non-ocular AEs
In a 1-year clinical study with
208 patients treated with MIEBO5:
-
No incidences of serious ocular AEs5
- <14% of patients had ≥1 ocular AE
- 24.5% had ≥1 non-ocular AE; most were mild (12.5%) or moderate (10.1%) in severity*
Low discontinuation rate due to AEs5
The most common ocular AEs were vitreous detachment (1.9% of patients, none considered treatment-related), allergic conjunctivitis (1.4%), blurred vision (1.4%), and increased lacrimation (1.4%)
SD, standard deviation; VAS, Visual Analog Scale.
*Only 1 non-ocular AE was considered by the investigators as related to study treatment.5
The MIEBO
INDICATION
MIEBO® (perfluorohexyloctane ophthalmic solution) is indicated for the treatment of the signs and symptoms of dry eye disease.
IMPORTANT SAFETY INFORMATION
- MIEBO should not be administered while wearing contact lenses. Contact lenses should be removed before use and for at least 30 minutes after administration of MIEBO
- Instruct patients to instill one drop of MIEBO into each eye four times daily
- The safety and efficacy in pediatric patients below the age of 18 have not been established
- The most common ocular adverse reaction was blurred vision (1% to 3% of patients reported blurred vision and conjunctival redness)
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Click here for full Prescribing Information for MIEBO.
References: 1. MIEBO. Prescribing Information. Bausch & Lomb, Inc. 2. Tauber J, Berdy GJ, Wirta DL, Krösser S, Vittitow JL; GOBI Study Group. NOV03 for dry eye disease associated with meibomian gland dysfunction: results of the randomized phase 3 GOBI study. Ophthalmology. 2023;130(5):516-524. doi:10.1016/j.ophtha.2022.12.021 3. Sheppard JD, Kurata F, Epitropoulos AT, Krösser S, Vittitow JL; MOJAVE Study Group. NOV03 for signs and symptoms of dry eye disease associated with meibomian gland dysfunction: the randomized phase 3 MOJAVE study. Am J Ophthalmol. 2023;252:265-274. doi:10.1016/j.ajo.2023.03.008 4. Data on file. Bausch & Lomb, Inc. 5. Protzko EE, Segal BA, Korenfeld MS, Krösser S, Vittitow JL. Long-term safety and efficacy of perfluorohexyloctane ophthalmic solution for the treatment of patients with dry eye disease: the KALAHARI study. Cornea. Published online November 3, 2023. doi:10.1097/ICO.0000000000003418
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INDICATION AND IMPORTANT
SAFETY INFORMATION
INDICATION
MIEBO® (perfluorohexyloctane ophthalmic solution) is indicated for the treatment of the signs and symptoms of dry eye disease.
IMPORTANT SAFETY INFORMATION
- MIEBO should not be administered while wearing contact lenses. Contact lenses should be removed before use and for at least 30 minutes after administration of MIEBO
- Instruct patients to instill one drop of MIEBO into each eye four times daily
- The safety and efficacy in pediatric patients below the age of 18 have not been established
- The most common ocular adverse reaction was blurred vision (1% to 3% of patients reported blurred vision and conjunctival redness)
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Click here for full prescribing Information for MIEBO.