Canada-based Bausch + Lomb, a global eye health business of Bausch Health Companies Inc (NYSE/TSX: BHC), and Novaliq GmbH, a biopharmaceutical company focusing on ocular therapeutics, announced on Tuesday statistically significant top-line data from the first Phase 3 trial (GOBI trial) evaluating the investigational drug NOV03 (perfluorohexyloctane) as a first-in-class eye drop with a novel mechanism of action to treat the signs and symptoms of dry eye disease (DED) associated with meibomian gland dysfunction (MGD).

The GOBI trial met both of its co-primary endpoints, including: change from baseline in total Corneal Fluorescein Staining (tCFS), a measure of assessing damage to the eye, and change from baseline in dryness score. The GOBI trial also met all of its secondary endpoints, showing statistically significant improvements in both the signs and symptoms of DED associated with MGD that were studied.

'More than 16 million adults in the United States have some form of dry eye disease, with meibomian gland dysfunction as a known cause for a majority of these cases,' said Joseph C Papa, chairman and CEO, Bausch Health. 'The rapid onset of action and statistical significance demonstrated in this trial is impressive. It also gets us a step closer to bringing forward this potential first-in-class treatment option, which could be a promising development for millions of patients.'

The Phase 3 program for NOV03 includes an ongoing second Phase 3, multi-centre, randomised, double-masked, saline-controlled trial (MOJAVE study) and a multi-centre, open-label, single-arm 12-month safety extension trial (KALAHARI study). Top-line results from MOJAVE, if positive, will allow for a filing to the U.S Food and Drug Administration (FDA) in 2022.