Eyenovia (NSDQ:EYEN) today announced positive results from a study of its microdose array print (MAP) pupil dilation technology.
Study data, published in Therapeutic Delivery, revealed pooled results from two prospective, double-masked, controlled, cross-over superiority Phase 3 studies. Those results concluded that a micro-dosed fixed-combination of tropicamide 1% and phenylephrine 2.5% for pupil dilation (mydriasis) is safe and effective while producing clinically relevant and statistically superior pupil dilation compared with either agent alone and placebo, according to a news release.
Approximately 93% of eyes treated with tropicamide-phenylephrine achieved 6 mm or greater dilation at 35 minutes post-dose compared to 78% with tropicamide and 2% with phenylephrine. The proportion of fully non-responsive pupils at 35 minutes post-dose was 98% with tropicamide-phenylephrine compared with 76% and 5%, respectively, with tropicamide and phenylephrine alone.
The study observed 3% of patients experiencing adverse events with the dosing and fewer than 1% of the patients reported blurred vision, reduced acuity, photophobia or installation site pain. The analysis included 131 subjects.
All treatment arms used Eyenovia’s proprietary Optejet dispenser designed for high-precision, targeted administration, delivering about 80% less medication and preservatives to patients than eyedroppers to potentially improve local tolerability.
The study’s publication follows the FDA accepting a New Drug Application for Eyenovia’s MydCombi pupil dilation agent, the fixed-combination mydriatic agent for potential use in comprehensive eye exams with a formulation for touchless fixed-combination microdosing to improve the patient experience.
“This publication further validates that microdosed tropicamide-phenylephrine with our proprietary and novel Optejet dispenser has many advantages that could make pupil dilation easier, more comfortable and safer. The Optejet may reduce cross-contamination risk because unlike an eyedropper bottle, the Optejet has no protruding parts. The MAP drug delivery may also enable anesthetic-free dilation and streamlines care, making the process more efficient,” Eyenovia team leader & head of medical affairs Beth Scott said in the release. “These results highlight the potential advantages of our Optejet dispenser to effectively and safely deliver advanced therapies, with the ability to be applied to additional medications and indications.”