All endpoints achieved in second phase 3 trial of NOV03 for dry eye disease
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NOV03 met all primary and secondary sign and symptom endpoints in a second phase 3 trial investigating the therapy for dry eye disease treatment, according to a press release from Bausch + Lomb and Novaliq.
NOV03 (perfluorohexyloctane) is a drop with a novel mechanism of action designed to treat dry eye associated with meibomian gland dysfunction. MOJAVE, a prospective, multicenter, randomized, double-masked, saline-controlled phase 3 study, enrolled 620 participants who received either NOV03 or placebo four times a day.
The change from baseline in total corneal fluorescein staining became significant at day 57 compared with the control group (P < .001). Additionally, the change in dryness score achieved significance at day 57 compared with the control group (P < .001).
All four secondary endpoints demonstrated statistical superiority over placebo, including change from baseline in total corneal fluorescein staining at day 15 (P = .001), change from baseline in dryness score at day 15 (P = .001), change from baseline in visual analogue scale burning and stinging at day 57 (P = .001) and change from baseline in central corneal fluorescein staining at day 57 (P < .001)
“The findings from this second phase 3 trial reinforce the results of the first phase 3 trial and further support 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 of Bausch Health, said in the release.
Bausch + Lomb anticipates the clinical program for NOV03 will end with the ongoing multicenter, open-label, single-arm, 12-month safety extension KALAHARI trial. A new drug application for NOV03 is expected to be filed with the FDA in 2022.
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