MydCombi. Eyenovia’s FDA-approved proprietary, first-in-class combination microdose formulation of tropicamide and phenylephrine for pupil dilation.
With MydCombi™, practices could potentially replace the current standard of care of 3 drops (anesthetic, tropicamide, phenylephrine). In clinical trials with MydCombi, less than 1% of subjects reported an AE of stinging , while still achieving effective pupil dilation1. 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. Plus, with no protruding parts and a recessed nozzle, the Optejet® is less likely to touch the eye of patients, compared to an eyedropper.
Disease State.
MydCombi is Eyenovia’s proprietary, first-in-class combination microdose formulation of tropicamide and phenylephrine for in-office pupil dilation. In the United States alone, there are an estimated 104 million eye exams performed annually which require pupil dilation2. Another 4 million dilations are performed for cataract surgery2.
Standard of Care (SOC).
The current mydriatic practice is to administer several conventional eyedrops sequentially. Typically, the patient is given a drop of anesthetic followed by separate drops of tropicamide and phenylephrine. Unfortunately, as the volume of a drop exceeds that of the capacity of the eye, patients often experience overdosing and overflow3.
Eyenovia Innovation.
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. In clinical trials with MydCombi, approximately 94% of treated eyes achieved 6mm or greater dilation at 35 minutes post-installation less than 1% of subjects reported an AE of stinging1.
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. Plus, with no protruding parts and a recessed nozzle, the Optejet less likely to touch the eye of patients, compared to an eyedropper.
1. Wirta, David. 2019, April. Two Phase 3 Studies Of The Safety And Efficacy Of Fixed Combination Phenylephrine 2.5%-Tropicamide 1% Ophthalmic Solution.
2. The State of the Optometric Profession (Jobson Medical Information, 2013).
3. American Academy of Ophthalmology (AAO). “Wouldn’t it be great if eyedrops didn’t spill out of your eyes?.” ScienceDaily. ScienceDaily, 13 November 2017.
MIST Phase III Trials.
Indication
MYDCOMBI (tropicamide 1% and phenylephrine HCl 2.5%) ophthalmic spray is indicated to induce mydriasis for routine diagnostic procedures and in conditions where short term pupil dilation is desired.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS: Known hypersensitivity to any component of the formulation
WARNINGS AND PRECAUTIONS
Not for Injection: Topical ophthalmic use
Significant Elevations in Blood Pressure: Caution in pediatric patients less than 5 years of age, and in patients with cardiovascular disease or hyperthyroidism. In patients at high risk, monitor blood pressure post treatment
Central Nervous System Disturbances: Caution in pediatric patients where rare incidences of central nervous system disturbances have been reported
Intraocular Pressure: May produce a transient elevation
Rebound Miosis: Reported 1 day after administration
DRUG INTERACTIONS
Atropine-like Drugs: May exaggerate the adrenergic pressor response
Cholinergic Agonists and Ophthalmic Cholinesterase Inhibitors: May interfere with the antihypertensive action of carbachol, pilocarpine, or ophthalmic cholinesterase inhibitors
Potent Inhalation Anesthetic Agents: May potentiate cardiovascular depressant effects of some inhalation anesthetic agents
ADVERSE REACTIONS
Most common ocular adverse reactions include transient blurred vision, reduced visual acuity, photophobia, superficial punctate keratitis, and mild eye discomfort. Increased intraocular pressure has been reported following the use of mydriatics
Systemic adverse reactions including dryness of the mouth, tachycardia, headache, allergic reactions, nausea, vomiting, pallor, central nervous system disturbances and muscle rigidity have been reported with the use of tropicamide
To report SUSPECTED ADVERSE REACTIONS, contact Eyenovia, Inc. At 1-833-393-6684 or FDA at 1-800-FDA-1088 www.fda.gov/medwatch
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