Patients with dry eye disease taking Bausch + Lomb and Novaliq's eye drop saw an improvement in the severity of eye dryness and damage to the eye during a phase 3 clinical trial.
The results beat placebo and met the two primary goals for the trial, called Mojave. This is the second time the drug, perfluorohexyloctane, has met all primary and secondary endpoints in a late-stage trial, the companies said Thursday. NOV03 also met all endpoints in a similar phase 3 trial called Gobi in April.
With the results in hand, Bausch Health's eye business and the German ocular biotech will submit the eye drop to the FDA next year. Companies are required to show safety and efficacy in at least two separate trials to support a regulatory filing in dry eye disease.
The treatment was tested in patients with dry eye disease associated with Meibomian gland dysfunction, which leads to increased tear evaporation. The disease impacts millions of Americans.
The water- and preservative-free solution achieved statistical significance on measures of damage to the eye and dryness at Day 57. The trial included 620 people 18 years and older who took either the eye drop or placebo four times a day. The treatment also beat placebo on a scale of burning/stinging.
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About 12.9% of patients in the eye drop group and 12.3% in the placebo group reported at least one treatment-emergent adverse event, but Bausch did not provide specifics.
Bausch acquired the exclusive license for the eye drop in the U.S. and Canada from Novaliq in December 2019 for undisclosed terms.
Other companies trying to tackle Meibomian gland dysfunction include Tarsus Pharmaceuticals, which reeled in an $88 million IPO last October, and Azura Ophthalmics, which raised $20 million, also last October.