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Eyenovia Inc.

Eyenovia makes first sale of drug-device combo for pupil dilation

[Image courtesy of Eyenovia]Eyenovia (Nasdaq:EYEN) today announced the first commercial sale of Mydcombi, its eye treatment for use with the Optejet delivery device.

In May, the FDA approved the Mydcombi treatment for use with Optejet. New York-based Eyenovia designed Mydcombi (tropicamide and phenylephrine hydrochloride ophthalmic spray) 1%/2.5% for inducing mydriasis for diagnostic procedures and in conditions where short-term pupil dilation is desired. Its approval marked the first approved fixed-dose combination of tropicamide and phenylephrine in the U.S.

The FDA nod was also the first for a product using Eyenovia’s proprietary Optejet device.

Get the full story at our sister site, Drug Delivery Business News.

FDA approves ophthalmic spray from Eyenovia

[Image courtesy of Eyenovia]Eyenovia (Nasdaq:EYEN) announced today that the FDA approved its Mydcombi treatment for use with the Optejet delivery device.

New York-based Eyenovia designed Mydcombi (tropicamide and phenylephrine hydrochloride ophthalmic spray) 1%/2.5% for inducing mydriasis for diagnostic procedures and in conditions where short-term pupil dilation is desired. It marks the first approved fixed-dose combination of tropicamide and phenylephrine in the U.S.

Eyenovia said it also represents the first product using Eyenovia’s proprietary Optejet device to receive any regulatory approval.

Get the full story at our sister site, Drug Delivery Business News.

Eyenovia unveils digital ocular drug delivery device

[Image courtesy of Eyenovia]Eyenovia (Nasdaq:EYEN) announced today that it is developing a microdosing system to facilitate the digital delivery of eye medications.

New York-based Eyenovia develops a pipeline of late-stage microdose array print (MAP) therapeutics. It aims for this system to improve the overall patient experience and streamline practice flow.

Get the full story at our sister site, Drug Delivery Business News.

Eyenovia enrolls first patient in Phase 3 trial for treating presbyopia

Eyenovia (NSDQ:EYEN) announced today that it enrolled the first patient in the second Phase 3 clinical trial for its MicroLine formulation.

New York-based Eyenovia designed its MicroLine proprietary pilocarpine formulation for temporary improvement in near vision (presbyopia).

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Eyenovia appoints Dr. Julia Haller to board of directors

Eyenovia (NSDQ:EYEN) announced today that it appointed renowned ophthalmologist Dr. Julia Haller to its board of directors.

New York-based Eyenovia adds the experienced Haller to its board as it continues to develop the MydCombi fixed-combination mydriatic agent for potential use in comprehensive eye exams with a formulation for touchless fixed-combination microdosing in an effort to improve the patient experience.

Get the full story at our sister site, Drug Delivery Business News.

Eyenovia partners with Eversana to commercialize pupil dilation agent

Eyenovia (NSDQ:EYEN) announced today that it partnered with Eversana to help commercialize MydCombi if it earns U.S. approval.

MydCombi is a fixed-combination mydriatic agent for potential use in comprehensive eye exams with a formulation for touchless fixed-combination microdosing in an effort to improve the patient experience. The FDA earlier this month accepted Eyenovia’s New Drug Application for MydCombi.

Get the full story at our sister site, Drug Delivery Business News.

Eyenovia touts study of pupil dilation treatment

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.

Get the full story at our sister site, Drug Delivery Business News.

FDA accepts New Drug Application for Eyenovia pupil dilation tech

Eyenovia (NSDQ:EYEN) announced today that the FDA accepted its New Drug Aplication for its MydCombi pupil dilation agent.

MydCombi is a fixed-combination mydriatic agent for potential use in comprehensive eye exams with a formulation for touchless fixed-combination microdosing in an effort to improve the patient experience, according to a news release.

Get the full story at our sister site, Drug Delivery Business News.