Eyenovia studies delivery of three therapeutics with new dispenser
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Eyenovia reported successful clinical trial results for three different ocular pharmaceutical solutions delivered with its Optejet microdose dispenser for mydriasis, myopia and presbyopia.
April Jasper, OD, FAAO, reported during an academy-sponsored press conference here at the American Academy of Optometry meeting that the Optejet delivers one-fourth the dose volume of traditional eye droppers, “expanding treatment options by increasing the therapeutic index of drugs.”
MydCombi (tropicamide 1%/phenylephrine 2.5%) for pupil dilation is undergoing phase 3 clinical trials, and the NDA filing is expected in late 2020, Jasper said.
Siddarth Rathi, OD, MBA, and colleagues separately shared results of Eyenovia’s MIST-1 and MIST-2 studies in a poster that indicated a fixed combination tropicamide 1% and phenylephrine 2.5% delivered superior mydriasis when compared to tropicamide alone, phenylephrine alone or placebo.
Jasper added during the press conference: “In the MIST study, the ability of MydCombi to dilate pupils 35 minutes post dosing was consistent across eye color and self-reported racial groups. Previous experience has been that darker irides have been slower to dilate.”
Jasper also discussed Eyenovia’s MicroPine, an atropine formulation for slowing myopia progression in children.
“By lowering the drug volume, the company hopes to improve upon the tolerability and safety profile of the drug while retaining efficacy,” she said.
“The CHAPERONE study is up and running,” Jasper continued. “Children as young as 6 are self-administering MicroPine. The company is looking to fully enroll the study by the middle of next year.”
Separate from the academy meeting, Bausch Health Companies announced Oct. 12 in a press release that it will acquire exclusive licensing rights in the U.S. and Canada to Eyenovia’s MicroPine.
According to the release, the terms of the licensing agreement specify that Bausch Health will make an upfront $10 million payment to Eyenovia and will assume oversight and costs related to the CHAPERONE study. Eyenovia is eligible to receive up to $35 million in additional payments based on approval- and launch-based milestones, as well as royalties based on gross profit on sales.
At the press conference, Jasper also explained that Eyenovia’s MicroLine for presbyopia is, “Optejet-delivered low-dose pilocarpine to improve near vision. On-demand pilocarpine means freedom from reading glasses for a morning or afternoon.”
According to an Eyenovia press release, MicroLine will be evaluated in the VISION-1 and VISION-2 phase 3 clinical studies.
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Rathi S, et al. Pupil dilation speed based on iris color and self-reported race in two phase 3 trials with microdose array print fixed combination tropicamide 1%-phenylephrine 2.5% ophthalmic solution: MIST-1 and MIST-2 pooled subgroup analysis. Presented at: American Academy of Optometry meeting; October 7-22, 2020; virtual meeting.
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