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MicroStat phase 3 data show positive mydriatic effect

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Phase 3 clinical trial data for MicroStat, a fixed-combination micro-formulation for pharmacologic mydriasis, showed a statistically and clinically superior mydriatic effect compared with the individual components of the formulation, according to a press release from Eyenovia.

The MIST-1 double-masked, randomized, superiority trial included 64 subjects in whom both eyes were treated on separate days with MicroStat, a fixed combination of phenylephrine 2.5% and tropicamide 1%. Results were compared against subjects treated with tropicamide only or phenylephrine only. The company’s OpteJet technology was used to deliver all treatments.

MicroStat reached the primary efficacy outcome of mean pupil dilation at 35 minutes after administration better than either individual component.

Additionally, 94% of MicroStat-treated eyes reached 6 mm or greater pupil dilation at 35 minutes after administration compared with 78% of the tropicamide-only group and 1.6% of the phenylephrine-only group; 57% of MicroStat-treated eyes reached 6 mm or greater dilation at 20 minutes after administration compared with 38% of tropicamide-treated eyes and no phenylephrine-treated eyes.