Bausch + Lomb bags FDA approval for dry eye disease treatment Miebo

After closing on its IPO last May in anticipation of its upcoming spinout from Bausch Health, eyecare specialist Bausch + Lomb has won its first prescription drug approval from the FDA.

Thursday, the FDA signed off on Bausch + Lomb's Miebo drops for dry eye disease. The drug is the first FDA-approved treatment to directly target tear evaporation and addresses a significant unmet need for patients, Bausch + Lomb CEO Brent Saunders said in a statement.

As one of the most common ocular surface disorders, dry eye disease impacts millions of people in the U.S. Excessive tear evaporation is a leading cause of dry eye disease and is often linked with signs of meibomian gland dysfunction (MGD), a group of disorders hallmarked by abnormalities of the oil glands along the eyelash line. 

The FDA approved Miebo based on two 57-day phase 3 trials that enrolled a total of 1,217 patients with a history of dry eye disease and signs of MGD. In the studies, patients experienced lasting symptom relief as early as Day 15 and maintained a statistically significant reduction in eye dryness compared with placebo, according to Bausch + Lomb.

The company collaborated on the drug with ocular therapy specialist Novaliq. During testing, Miebo carried the moniker NOV03.

Bausch snapped up the exclusive license for the med in the U.S. and Canada in late 2019 for an undisclosed price. It’s planning for the U.S. commercial launch in the second half of 2023, Saunders said in a statement.

But a generic challenger to AbbVie’s chronic dry eye med Restasis may put a wrinkle in Miebo’s commercial potential. After Viatris launched a generic in 2022, sales for AbbVie's branded drug fell 48% last year. Generics to popular brands can often weigh on pricing for an entire class of therapies.

Meanwhile, another competitor might enter the dry eye space this fall in Alderya Therapeutics’ reproxalap. The drug is under review at the FDA with a decision date slated for November.