NOV03 meets primary, secondary endpoints in phase 3 trial
NOV03 met the primary and secondary endpoints in its first phase 3 trial, according to a press release from Bausch + Lomb and Novaliq.
NOV03 (perfluorohexyloctane) is being evaluated to treat dry eye disease signs and symptoms associated with meibomian gland dysfunction.
The multicenter, randomized, double-masked, saline-controlled GOBI trial enrolled 597 patients who were randomly assigned to receive NOV03 or saline solution placebo four times daily.
The eye drop met both primary co-endpoints, including a change from baseline in total corneal fluorescein staining with results through day 57 compared with control (P < .001) and a change from baseline in dryness score through day 57 compared with control (P < .001).
NOV03 demonstrated “statistical superiority” over the control group in all four secondary endpoints, including change from baseline in total corneal fluorescein staining at day 15 (P = .001), change from baseline in dryness score at day 15 (P = .009), change from baseline in burning and stinging on a visual analogue scale at day 57 (P = .006) and change from baseline in central corneal fluorescein staining at day 57 (P < .001)
“No treatment-emergent adverse events were reported by more than 2% of subjects in either treatment group,” the release said. The percentage of patients who reported at least one ocular treatment-emergent adverse event was 9.6% in the NOV03 arm and 7.5% in the control arm.
In 2019, Bausch Health licensed NOV03 from Novaliq for development in the United States and Canada.
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