FDA approves Miebo to treat signs, symptoms of dry eye disease
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Key takeaways:
- The FDA approved Miebo for the treatment of dry eye disease signs and symptoms.
- Miebo directly targets tear evaporation.
The FDA approved Miebo for the treatment of signs and symptoms of dry eye disease, Bausch + Lomb and Novaliq announced in a press release.
Miebo (perfluorohexyloctane ophthalmic solution), formerly known as NOV03, is the only FDA-approved treatment for dry eye disease (DED) that directly targets tear evaporation.
The approval was supported by positive data from the GOBI and MOJAVE phase 3 pivotal clinical trials, which included 1,217 patients with DED and clinical signs of meibomian gland dysfunction. Miebo consistently met primary clinical sign and patient-reported symptom endpoints in the trials.
“Today’s FDA approval of Miebo further advances DED treatment by addressing a significant unmet need for millions of people suffering with this disease,” Brent Saunders, chairman and CEO of Bausch + Lomb, said in the release. “We are proud to bring to market the first and only prescription eye drop approved in the United States for the treatment of DED that directly targets evaporation. We expect to make Miebo commercially available in the second half of this year.”
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