Dry eye disease cream demonstrates improvement, rapid onset of action in phase 2 trial
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AXR-270 demonstrated "statistically and clinically meaningful improvement" in patients with dry eye disease associated with meibomian gland dysfunction, according to a press release from AxeroVision.
In a phase 2, multicenter, randomized, double-masked trial, 129 patients were separated into three groups. Each group was treated for 3 weeks. The treatment groups were AXR-270 0.2% cream, AXR-270 2% cream and a vehicle control, the release said. Incidence of adverse events at day 22 was the primary outcome measure.
AXR-270 demonstrated improvement from baseline in eye dryness score (P < .001), eye discomfort score (P < .001), tear breakup time (P < .01) and total fluorescein staining (P < .001). The formula achieved superiority to the vehicle in "some measures" and demonstrated rapid onset of action, the release said.
"Results from the phase 2 study showed statistically and clinically meaningful improvement in both a sign and symptom of dry eye disease associated with MGD," Stephen C. Pflugfelder, MD, professor and James and Margaret Elkins Chair in Ophthalmology, Baylor College of Medicine, and scientific advisor to AxeroVision, said in the release.
AxeroVision plans to enroll about 800 patients in phase 3 trials comparing AXR-270 with a control in the first half of 2022.
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