AxeroVision announced positive results from a phase 2 trial of AXR-270, the company’s novel, proprietary, once-daily glucocorticoid cream, in patients with signs and symptoms of dry eye disease (DED) associated with meibomian gland dysfunction (MGD). AXR-270 cream produced clinically meaningful improvements from baseline for all clinical signs and symptoms assessed in the trial.
In the multicenter phase 2 trial, 129 subjects were randomized 1:1:1 to double-masked, once-daily treatment with AXR-270 0.2% cream (low dose), AXR-270 2% cream (high dose), or placebo for 3 weeks. Incidence of ocular and systemic adverse events at Day 22 was analyzed as the primary outcome measure, and the data showed that both AXR-270 0.2% and 2% had an excellent safety profile and were well-tolerated.
Endpoints exploring the efficacy of AXR-270 0.2% for improving the signs and symptoms of DED showed it was associated with statistically significant improvements from baseline to Day 22 in Eye Dryness Score, Eye Discomfort Score, tear breakup time and total corneal fluorescein staining. Superiority of AXR-270 0.2% cream versus placebo was achieved for some measures and it demonstrated rapid ons...
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