Efficacy
Wirta, D. L., Walters, T. R., Flynn, W. J., Rathi, S., & Ianchulev, T. (2021). Mydriasis with micro-array print touch-free tropicamide-phenylephrine fixed combination MIST: pooled randomized Phase III trials. In Therapeutic Delivery (Vol. 12, Issue 3, pp. 201–214). Future Science Ltd. https://doi.org/10.4155/tde-2021-0011
MIST-1 and MIST-2 pooled, mean pupil diameter vs measurement time, by treatment group. Vertical bars show 95% confidence interval for the mean at each point. Smooth curves are based on an 8 degrees of freedom (df) generalized additive model (GAM) smooth through time, adjusting for baseline pupil diameter. Confidence intervals are not adjusted for correlation.
- MydCombi introduces an ‘anesthetic-free’ dilation to reduce exposure to unnecessary agents, streamline routine ophthalmic care for patients, technicians and physicians and may enhance office efficiency, practice flow and patient experience
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At 35 minutes post-dose, the mean change in pupil diameter was 4.7 mm with MydCombi, 4.1 mm with tropicamide, and 0.9 mm with phenylephrine in MIST-1, and was 4.8 mm with MydCombi and 0.1 mm with placebo in MIST2. MydCombi was statistically superior to tropicamide administered alone and phenylephrine administered alone.
- The proportion of eyes that achieved a pupil diameter ≥ 6.0 mm at 35 min post dose was 93.3% with MydCombi compared with 78.2% with TR and 1.6% with PH.
Safety Features
- The rate of adverse events was low (4 out of 131 patients), and no systemic or serious adverse events were reported
- All ocular AEs were transient and resolved prior to study exit
- The design of MydCombi allows for high precision targeted administration of TR-PH (∼8 μl/dose) without use of prior anesthesia, resulting in lower drug exposure and significantly reduced overflow risk than with eye drops
- Patients can be dilated sitting upright and without anesthetic making for a comfortable process. Patients have the opportunity to be dilated while in the waiting room.
- MydCombi has no protruding parts to touch the ocular surface, thus minimizing cross-contamination risk
Administering MydCombi
Important: Keep MydCombi dispenser upright during use to maintain dose volume.
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