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HomeminewsFDA Approval for New Dry Eye Drop

FDA Approval for New Dry Eye Drop

Bausch and Lomb and Novaliq have announced United States Food and Drug Administration (FDA) approval for an ophthalmic solution for the treatment of dry eye disease (DED) – the first that directly targets tear evaporation.

According to the companies, Miebo (perfluorohexyloctane ophthalmic solution) is the first and only prescription eye drop approved for DED that directly targets tear evaporation, based on consistent results from a pair of pivotal Phase 3 trials.

“(The) FDA approval of Miebo further advances DED treatment by addressing a significant unmet need for millions of people suffering with this disease,” Bausch and Lomb Chairman and Chief Executive Officer Brent Saunders said in a news release.1

Miebo is expected to be commercially available in the US in the second half of this year.

DED is one of the most common ocular surface disorders.2 A leading cause of DED is excessive tear evaporation which, due to an altered tear lipid layer, is often associated with the clinical signs of meibomian gland dysfunction (MGD), the companies’ statement said.

An unstable tear film triggers increased ocular surface desiccation, inflammation, and damage to the ocular surface.3,4 Miebo is designed to reduce tear evaporation at the ocular surface.5,6

The companies noted that in GOBI and MOJAVE, two Phase 3 pivotal clinical trials which enrolled more than 1,200 patients (randomized 1:1 to perfluorohexyloctane ophthalmic solution or hypotonic saline) with a history of DED and clinical signs of MGD, Miebo consistently met primary clinical signs and patient-reported symptom endpoints.

1. Bausch and Lomb, Bausch + Lomb and Novaliq Announce FDA Approval of MIEBO (Perfluorohexyloctane Ophthalmic Solution) for the Treatment of the Signs and Symptoms of Dry Eye Disease, news release, 18 May 2023, available at: bausch.com/news/releases/?id=156 [accessed 19 May 2023].
2. National Eye Institute. Dry Eye. Last updated 8 April 2022. Available at nei.nih.gov/learn-about-eye-health/eye-conditions-and-diseases/dry-eye [Accessed 2 May 2023].
3. Craig, J.P., Nelson, J.D., Azar, D.T., et al., TFOS DEWS II report executive summary. Ocul Surf. 2017;15(4):802-812. doi:10.1016/j.jtos.2017.08.003.
4. Pflugfelder, S.C., Paiva, C.S., The pathophysiology of dry eye disease: what we know and future directions for research. Ophthalmology. 2017;124(suppl 11):S4-S13. doi:10.1016/j.ophtha.2017.07.010.
5. Nichols, K.K., Foulks, G.N., Bron, A.J., et al., The international workshop on Meibomian gland dysfunction: executive summary. Invest Ophthalmol Vis Sci. 2011;52(4):1922-1929. doi:10.1167/iovs.10-6997a.
6. Borchman, D., Vittitow, J., Ewurum, A., Veligandl, S.R., Spectroscopic study of perfluorohexyloctane human Meibum interactions. Invest Ophthalmol Vis Sci. 2022;63:1525.