MIM-D3: Phase III data
Top-line data from the double-blind, U.S. Phase III MIM-725 trial in 403 patients with dry eye syndrome showed that twice-daily 1% MIM-D3 significantly improved central corneal fluorescein staining from baseline to week 8 vs. placebo (p=0.0134) and non-significantly improved total corneal fluorescein staining from baseline to week 8 vs. placebo (p=0.05). According to clinicaltrials.gov, the co-primary endpoints of the trial are corneal fluorescein staining and ocular dryness. Mimetogen did not report data on the latter. MIM-D3 also significantly improved several vision-related function symptoms of dry eye disease as measured by the OSDI questionnaire from baseline to week 8 vs. placebo, including mean blurred vision (p=0.0393), reading (p=0.0433) and watching TV scores (p=0.0046). MIM-D3 was well tolerated with no unexpected or serious ocular adverse events reported. The most common reported ocular adverse events were reduction in visual acuity, instillation-site pain and eye irritation. The company said it has met with FDA to discuss next steps and is preparing additional clinical and non-clinical studies of MIM-D3, but did not respond with details in time for publication. ...