Bausch + Lomb and Novaliq announced statistically significant data from the second phase 3 (MOJAVE) 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 findings from this second phase 3 trial reinforce the results of the first phase 3 trial and further supports the efficacy and safety profile of NOV03 as a potential important new treatment option for the millions of people living with dry eye disease associated with MGD,” Joseph C. Papa, chairman and CEO, Bausch Health, said in a company news release.
“These results mark another important milestone in bringing NOV03 to market as a potential first-in-class treatment, and we anticipate filing a new drug application to the U.S Food and Drug Administration in 2022.”
The MOJAVE trial met both primary sign and symptom endpoints:
The MOJAVE trial also met all of its secondary endpoints, showing statistically significant improvements in each of the signs and symptoms of DED associated with MGD that were evaluated.
“With these results, consistent statistically significant efficacy, safety and tolerability have now been demonstrated in both NOV03 Phase 3 trials, as well as in the Phase 2 trial,” said John Sheppard, M.D., president of Virginia Eye Consultants, professor of Ophthalmology at the Eastern Virginia Medical School, Norfolk, Va., and trial investigator.
“If approved, NOV03 would help address dry eye disease associated with MGD for the growing number of dry eye disease patients seen every day in clinical practice, offering eye care professionals a promising new therapeutic approach.”
The clinical development program for NOV03 is expected to conclude with an ongoing multi-center, open-label, single-arm, 12-month safety extension trial (KALAHARI).
The results were based on data from 620 participants aged 18 years and older who were randomized to either receive treatment with NOV03 four times daily or administration of placebo four times daily.
The prospective, multi-center, randomized, double-masked, saline-controlled Phase 3 study, which was conducted at 40 locations in the United States, also included four prespecified secondary endpoints.
All four demonstrated statistical superiority over placebo: change from baseline in tCFS at day 15 [p = 0.001]; change from baseline in dryness score at day 15 [p = 0.001]; change from baseline in VAS burning/stinging at day 57 [p = 0.001]; and change from baseline in central Corneal Fluorescein Staining (cCFS) at day 57 [p < 0.001].
NOV03 was well tolerated with instillation site reactions below 0.5%. No treatment emergent adverse events (TEAEs) were reported by more than 2% of subjects in either treatment group.
Overall, the number of patients reporting at least one TEAE was similar when comparing treatment and control arms: 12.9% and 12.3% for the treatment and control arms, respectively.