Exciting News for Dry Eye Sufferers: MIEBO Approved by FDA on May 18, 2023!
Bausch + Lomb Corporation and Novaliq GmbH announced the FDA's approval of MIEBO (perfluorohexyloctane ophthalmic solution) for the treatment of the signs and symptoms of dry eye disease (DED), making it the first and only prescription eye drop approved for dry eye disease that directly targets tear evaporation.
If you have been struggling with dry eye disease, particularly due to tear evaporation, this news may bring tremendous relief.
Let’s now delve into the intriguing details of dry eyes and MIEBO.
A quick recap on dry eye disease (DED)
Dry Eye Disease, commonly known simply as dry eye, affects a significant number of Americans. Statistics indicate around 16 million Americans have dry eyes.
DED occurs when the eyes produce an inadequate amount of tears or when tears evaporate too rapidly, resulting in dryness, discomfort, and potential damage to the eye's surface.
The treatment for dry eye depends on the underlying cause, ranging from environmental factors to various medical conditions, including Meibomian gland dysfunction (MGD)*. And the treatment options may involve artificial tears and ointments, medications, nasal sprays, home remedies, and more.
*Meibomian gland dysfunction is a common condition that occurs when the meibomian glands don’t produce enough oil or the oil is of poor quality. The oil is necessary to reduce the evaporation of tears.
What is MIEBO (perfluorohexyloctane ophthalmic solution)?
MIEBO is a prescription eye drop for DED targeting tear evaporation. It works by forming a protective monolayer at the air-liquid interface of the tear film.1
The FDA approved MIEBO for the treatment of the signs and symptoms of Dry Eye Disease (DED) based on the results of two Phase 3 clinical trials, namely GOBI and MOJAVE. These trials involved over 1,200 patients with a history of DED and clinical signs of Meibomian gland dysfunction (MGD).2,3
In the studies, MIEBO demonstrated effectiveness in treating both the signs and symptoms of dry eye disease. Patients experienced relief from their symptoms as early as day 15, with continuous improvement observed until day 57. The results from both studies showed that compared to the control group, MIEBO significantly reduced patient-reported eye dryness and corneal fluorescein staining, which provides valuable insights into the eye's surface health.2,3
The most frequently reported side effects were blurry vision (experienced by 1.3-3% of patients) and redness in the eyes (experienced by 1-3% of patients).2,3
Renowned experts in the field have expressed their excitement and MIEBO’s potential to address the unmet needs of patients with evaporative dry eye. Dr. Preeya Gupta, M.D., cornea and cataract surgeon at Triangle Eye Consultants in Raleigh, North Carolina, stated in the product’s press release, "In the two pivotal clinical trials, MIEBO addressed the persistent and chronic nature of DED by providing sustained improvement in both the signs and symptoms of DED."4
Paul Karpecki, O.D., director of Cornea and External Disease at the Kentucky Eye Institute, and associate professor at the University of Pikeville, Kentucky College of Optometry, also commented, "Tear evaporation, which is a leading driver of DED, presents a significant treatment challenge. With the approval of MIEBO, eye care professionals can now take a new approach to DED therapy with a first-in-class water- and preservative-free prescription treatment option that specifically addresses tear evaporation."4
MIEBO is expected to be commercially available in the second half of this year, offering a much-needed treatment option for individuals struggling with evaporative dry eye.4
Other important information1
- Patients should remove contact lenses before using MIEBO and wait for at least 30 minutes before reinserting.
- It is important for patients to use MIEBO exactly as prescribed.
- It is not known if MIEBO is safe and effective in children under the age of 18.
- The most common eye side effect seen in studies was blurred vision (1% to 3 % of patients reported blurred vision and eye redness).
MIEBO is the first and only prescription eye drop approved for DED that directly targets tear evaporation. This innovative treatment option has shown promising results in improving the signs and symptoms of DED in clinical trials. With the anticipated release of MIEBO in the latter half of this year, individuals afflicted by evaporative dry eye can anticipate a fresh and effective treatment option on the horizon.
1. MIEBO package insert. 2023 May 21.
2. Tauber J, Berdy GJ, Wirta DL, et al. 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 J, Kurata F, Epitropoulos AT, et al. NOV03 for signs and symptoms of dry eye disease associated with meibomian gland dysfunction: The randomized phase 3 Mojave study. American Journal of Ophthalmology. Published online ahead of print. March 20 2023. doi:10.1016/j.ajo.2023.03.008
4. MIEBO press release. https://www.bausch.com/news/releases/?id=156. Access May 21, 2023