Efficacy of the MydCombi on Pupillary Dilation in Pediatric and Adult Patients

Summary

To raise the standard of care, improve the overall patient experience and streamline practice flow, Eyenovia has developed an innovative mydriatic to be delivered as a microdose by a specialized dispenser. While still achieving effective pupil dilation, MydCombi has the potential to increase patient throughput at practicing offices by decreasing time spent eye dropping patients, eliminating time wasted waiting between drop instillations and ensuring more accurate drug delivery. The proposed study hopes to demonstrate the non-inferiority of using MydCombi to achieve pupillary dilation in patients compared to standard of care eye drops.

Timeline

Start

2024-10-01

Primary completion

2025-07-07

Completion

2025-07-07

Outcome

Met primary endpoint

paper Compared with eye drops, the spray met noninferiority criteria for maximum pupil diameter and pupillary constriction percentage. PMID 41338301 ↗

Publications

• Godfrey A, Menon S, Takla P, Lu J, Chen T, Bass O, Brown M, Indaram M, Oatts JT. A Small-Volume Topical Ophthalmic Spray for Pupillary Dilation in Children: A Randomized, Masked, Noninferiority Trial. Ophthalmology. 2026 Apr;133(4):515-521. doi: 10.1016/j.ophtha.2025.11.009. Epub 2025 Dec 1.

Drugs

Indications