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 […]
Eyenovia Inc.
Eyenovia unveils digital ocular drug delivery device
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. The investigational device showed promise in delivery cleaner […]
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). The Vision-2 trial, a double-masked, placebo-controlled, cross-over superiority trial will treat 140 subjects with presbyopia, randomly assigning them […]
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 to improve the patient […]
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 […]
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 […]
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. New York-based Eyenovia’s proprietary Optejet […]
Eyenovia kicks off second Ph3 trial for pupil dilation tech
Eyenovia (NSDQ:EYEN) said this week that it finished patient enrollment in its Phase III Mist-1 trial and enrolled the first patient in its second Phase III trial for the company’s combination eye solution delivered as a micro-dose using its Optejet device. The company is studying the therapy for pharmacologic mydriasis – pupil dilation for eye exams. […]
Eyenovia touts publication of intraocular pressure data for micro-dose tech
Eyenovia (NSDQ:EYEN) said this week that the results of its Phase II PG21 study were published in the Nov. issue of the journal Clinical Ophthalmology. The New York-based company’s Phase II study evaluated the effect of self-administered micro-dose latanoprost on intraocular pressure. In the trial, participants successfully self-administered using Eyenovia’s device 88% of the time after limited […]
Eyenovia launches Ph3 trial for pupil dilation tech
Eyenovia (NSDQ:EYEN) said today that it enrolled the first patient in the first of two Phase III trials of the company’s MicroStat program. The Mist-1 and Mist-2 trials are slated to study the safety and efficacy of the company’s 2.5% phenylephrine, 1% tropicamide eye solution, delivered as a micro-dose using the Optejet device. The company […]
