Bausch + Lomb Announces Results from First Phase 3 Trial of NOV03
Bausch + Lomb and Novaliq, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics, announced statistically significant topline 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, achieved statistical significance at day 15 (secondary endpoint), with continued results through day 57 (primary endpoint) compared to control;
- Change from baseline in dryness score achieved statistical significance at day 15 (secondary endpoint), with continued results through day 57 (primary endpoint) compared to control, as rated on a visual analogue scale (VAS) ranging from 0-100 (0 = no discomfort; 100 = maximum discomfort).
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.
“There is currently no pharmaceutical therapy available in the United States for the treatment of dry eye disease associated with meibomian gland dysfunction,” said Yolande Barnard, vice president and general manager, U.S. Pharmaceuticals, Bausch + Lomb. “These outstanding topline results are very encouraging that we may be able to bring this first-in-class treatment option to market for the millions of patients who have dry eye disease associated with meibomian gland dysfunction.”
“I am very impressed by the positive results from this first Phase 3 study of NOV03, in particular the findings at day 15 in treating the signs and symptoms of the disease,” said Joseph Tauber, M.D., founder of Tauber Eye Center in Kansas City, Mo., and trial investigator. “These findings validate the importance of the continued development of NOV03, and I look forward to seeing additional results from the Phase 3 program.”
The Phase 3 program for NOV03 includes an ongoing second Phase 3, multi-center, randomized, double-masked, saline-controlled trial (MOJAVE study) and a multi-center, open-label, single-arm 12-month safety extension trial (KALAHARI study). 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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