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Bausch + Lomb : First Phase 3 Trial Of NOV03 On Dry Eye Disease Meets Primary And Secondary Goals

Bausch + Lomb, eye health business of Bausch Health Companies Inc. (BHC,BHC.TO), and Novaliq GmbH said that all primary and secondary endpoints were achieved in the first phase 3 trial of NOV03 or perfluorohexyloctane in dry eye disease associated with meibomian gland dysfunction.

The trial met both of its co-primary endpoints, including change from baseline in total Corneal Fluorescein Staining, a measure of assessing damage to the eye, achieved statistical significance at day 15, with continued results through day 57 compared to control.

It also included change from baseline in dryness score achieved statistical significance at day 15, with continued results through day 57 compared to control, as rated on a visual analogue scale ranging from 0-100. Zero is equal to no discomfort, while 100 is equal to maximum discomfort.

The trial also met all of its secondary endpoints, showing statistically significant improvements in both the signs and symptoms of dry eye disease associated with meibomian gland dysfunction that were studied.

The phase 3 program for NOV03 includes an ongoing second Phase 3, multi-center, randomized, double-masked, saline-controlled trial and a multi-center, open-label, single-arm 12-month safety extension trial. Topline results from MOJAVE, if positive, will allow for a filing to the U.S Food and Drug Administration in 2022.

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