The only Rx eye drop for DED that directly targets tear evaporation¹
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
Please see additional Important Safety Information at the bottom of this page.
Click here for full Prescribing Information for MIEBO.
MIEBO contains only 1 ingredient1
Vehicle free
Preservative free
Steroid free
Water free
The MIEBO difference
MIEBO spreads quickly and evenly.2,3The layer formed by MIEBO helps inhibit tear evaporation.
Over time, and when used as directed, the result is a reduction in ocular surface damage.1,4
Mimics key functions of natural meibum2,4–6
Promotes healing on the ocular surface1,5
May reduce friction6-8
The exact mechanism of action for MIEBO in DED is not known.¹
MIEBO efficacy and tolerability
Efficacy results across 2 pivotal studies where 100% of patients had clinical signs of meibomian gland dysfunction (MGD) at enrollment1,7,8:
- Rapid and sustained improvement in TOTAL corneal fluorescein staining (tCFS) as early as Day 15 through Day 571,9
- Rapid and sustained relief of EYE DRYNESS as early as Day 15 through Day 571,9
- Significant improvements in CENTRAL corneal fluorescein staining at Day 579
In clinical trials, blurred vision and conjunctival redness were reported in 1% to 3% of patients.1,7–9*
Study design: Two 57-day, multicenter, double-masked, saline-controlled studies (GOBI and MOJAVE) were conducted in adults ≥18 years old with a self-reported history of DED in both eyes. Across GOBI and MOJAVE, 614 patients received MIEBO and 603 patients received control with 591 and 575, respectively, assessed on Day 57. Primary endpoints were change from baseline in tCFS and change from baseline in eye dryness score at Day 57. Day 15 was the earliest time point at which signs and symptoms were evaluated in the trials. Day 57 was the last.1,7,8
*Data were pooled from >1200 total patients from 2 pivotal clinical studies (GOBI and MOJAVE). Of the 614 patients who received MIEBO, there were no incidences of serious ocular adverse events (AEs) with MIEBO. Most AEs were considered mild. The discontinuation rate for MIEBO due to AEs was comparable to control (pooled: 0.2% vs 0.5%; GOBI: 0.3% vs 1.0%; MOJAVE: 0% vs 0%). 0.5% (pooled) of patients experienced instillation site pain AEs, such as burning or stinging (GOBI: 1.0%; MOJAVE: 0%). 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% to 3% of patients.1,7–9
The MIEBO difference
In pivotal studies, the majority of patients rated MIEBO as COMFORTABLE OR VERY COMFORTABLE on instillation.9†
There may be no ocular sensation or blink reflex upon instillation6
The small drop size (11 μL) means MIEBO may feel different from formulations containing water4‡
DED, dry eye disease. |
|
| † | Questionnaire was given on Day 1 of the GOBI and MOJAVE studies. Mean pooled comfort score was 8.0 for MIEBO and 8.4 for saline (scale of 0-10, 0 = not comfortable and 10 = very comfortable). 81% of patients treated with MIEBO reported a score of 7 or higher.9 |
| ‡ |
Aqueous formulations have a typical drop size of ~30-50 μL. |
DED, dry eye disease. |
|
| † | Questionnaire was given on Day 1 of the GOBI and MOJAVE studies. Mean pooled comfort score was 8.0 for MIEBO and 8.4 for saline (scale of 0-10, 0 = not comfortable and 10 = very comfortable). 81% of patients treated with MIEBO reported a score of 7 or higher.9 |
| ‡ |
Aqueous formulations have a typical drop size of ~30-50 μL. |
DED, dry eye disease. |
|
| † | Questionnaire was given on Day 1 of the GOBI and MOJAVE studies. Mean pooled comfort score was 8.0 for MIEBO and 8.4 for saline (scale of 0-10, 0 = not comfortable and 10 = very comfortable). 81% of patients treated with MIEBO reported a score of 7 or higher.9 |
| ‡ |
Aqueous formulations have a typical drop size of ~30-50 μL. |
Learn more at
MIEBO-ECP.COM
IMPORTANT SAFETY INFORMATION (CONTINUED)
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.
Please see additional Important Safety Information at the top of this page.
Click here for full Prescribing Information for MIEBO.
References: 1. MIEBO. Prescribing Information. Bausch & Lomb, Inc. 2. Meinert H, Roy T. Semifluorinated alkanes – a new class of compounds with outstanding properties for use in ophthalmology. Eur J Ophthalmol. 2000;10(3):189-197. doi:10.5301/EJO.2008.1838 3. Agarwal P, Khun D, Krösser S, et al. Preclinical studies evaluating the effect of semifluorinated alkanes on ocular surface and tear fluid dynamics. Ocul Surf. 2019;17(2):241-249. doi:10.1016/j.jtos.2019.02.010 4. Sheppard JD, Nichols KK. Dry eye disease associated with meibomian gland dysfunction: focus on tear film characteristics and the therapeutic landscape. Ophthalmol Ther. 2023;12(3):1397-1418. doi:10.1007/s40123-023-00669-1 5. Vittitow J, Kissling R, DeCory H, Borchman D. In vitro inhibition of evaporation with perfluorohexyloctane, an eye drop for dry eye disease. Curr Ther Res Clin Exp. 2023;98:100704. doi:10.1016/j.curtheres.2023.100704 6. Schmidl D, Bata AM, Szegedi S, et al. Influence of perfluorohexyloctane eye drops on tear film thickness in patients with mild to moderate dry eye disease: a randomized controlled clinical trial. J Ocul Pharmacol Ther. 2020;36(3):154-161. doi:10.1089/jop.2019.0092 7. 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 8. 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 9. Data on file. Bausch & Lomb, Inc.
©2024 Bausch + Lomb
MBO.0561.USA.24
©2024 Bausch + Lomb
MBO.0561.USA.24