Eyenovia (Nasdaq:EYEN) announced that it began manufacturing batches of its Mydcombi product for its next-generation delivery platform. Manufacturing registration batches of the FDA-approved Mydcombi mydriasis product marks a key step in the approval process for the company’s state-of-the-art Gen-2 Optejet dispensing platform, according to a news release. The company plans to have Mydcombi undergo 12-month […]
Eyenovia Inc.
Eyenovia makes first sale of drug-device combo for pupil dilation
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 […]
FDA approves ophthalmic spray from 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 […]
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. […]
