FDA approves Bausch + Lomb, Novaliq candidate NOV03 for signs and symptoms of dry eye disease

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Bausch + Lomb and Novaliq have announced that the FDA approved MIEBO, (perfluorohexyloctane ophthalmic solution) for the signs and symptoms of dry eye disease (DED). Known as NOV03 as it passed through the pipeline, MIEBO now has the distinction of being the first and only FDA-approved DED treatment that targets tear evaporation. Excessive tear evaporation due to an altered lipid layer has been long associated with dry eye disease and Meibomian gland dysfunction (MGD).

“Today’s FDA approval of MIEBO further advances DED treatment by addressing a significant unmet need for millions of people suffering with this disease,” said Brent Saunders, chairman and CEO of Bausch + Lomb, in a press 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.”

The approval is based on the Gobi and Mojave phase 3 pivotal studies, in which MIEBO met primary endpoints for both signs and symptoms. The two primary endpoints were change from baseline at week eight (day 57 ± 2) in total corneal fluorescein staining (tCFS) and eye dryness Visual Analog Scale (VAS) score. Patients experienced relief of symptoms as early as day 15 and through day 57 with statistically significant reduction in VAS eye dryness score favoring MIEBO observed in both studies. Additionally, at days 15 and day 57, a significant reduction in tCFS favoring MIEBO was observed in both studies. The most common adverse events reported were blurred vision (1.3-3%) and eye redness (1-3%).

“We believe that MIEBO will address a significant unmet need for the many Americans who struggle with evaporative dry eye,” said Christian Roesky, PhD, CEO of Novaliq, in a press release. “We are grateful to Bausch + Lomb for their continued collaboration in bringing this unique new treatment option to market.”

"It is exciting to see a new topical therapeutic approved for the signs and symptoms of dry eye, MIEBO (perfluorohexyloctane ophthalmic solution ) by Bausch + Lomb," commented Kelly Nichols, OD, MPH, PhD, FAAO, dean of the University of Alabama at Birmingham School of Optometry and editorial advisory board member of Optometry Times. "This therapeutic agent, tested under the name NOV03 in patients with meibomian gland dysfunction is a unique water-free drop for evaporative dry eye. I am looking forward to seeing how practitioners incorporate this into dry eye practice."

MIEBO is indicated for the treatment of signs and symptoms of dry eye disease. Patients are advised to remove contact lenses prior to use, and a waiting period of 30 minutes after application is advised before reinserting lenses. Safety and efficacy in children under 18 was not investigated in the phase 3 clinical trials.

"It's encouraging to see a new class of drug in the dry eye space, especially one shown to have effect on the meibomian glands, which has been uncharted thus far," said Crystal Brimer, OD, founder of the Dry Eye Institute and editorial advisory board member of Optometry Times. "I have a list of patients anxiously waiting for the samples to arrive!"

“Bausch + Lomb is deeply committed to bringing forward medicines that address unmet medical needs, and MIEBO is a prime example of this commitment being realized,” said Yehia Hashad, MD, executive vice president of research & development and chief medical officer of Bausch + Lomb. “We are extremely grateful to all of our collaborators, including trial patients, clinical investigators and our R&D team, for their tireless contributions to this important milestone.”