New FDA Approval: MYDCOMBI
We have exciting news for patients at Compton Eye Associates: the FDA has recently approved MYDCOMBI™, a novel ophthalmic spray developed by Eyenovia, Inc. This approval marks a significant milestone in eye care, particularly for diagnostic procedures requiring pupil dilation (mydriasis).
MYDCOMBI is the first FDA-approved fixed combination of tropicamide and phenylephrine in the United States. It’s unique in that it uses Eyenovia’s proprietary Optejet® device, which represents a significant advancement over traditional eye dropper bottles. This device uses high-precision piezo-print technology to deliver a micro-mist that coats the eye, ensuring efficient and comfortable application.
One of the key benefits of MYDCOMBI is its ability to improve the efficiency of eye exams and certain eye surgeries by inducing mydriasis more effectively. Its formulation includes phenylephrine hydrochloride 2.5% and tropicamide 1%, which are delivered as a micro-mist to the ocular surface, reducing the volume of solution required compared to conventional eyedroppers. This potentially decreases the risk of overdosing and exposure to drug and preservatives.
MYDCOMBI was supported by two completed Phase 3 clinical trials, MIST-1 and MIST-2, which highlighted its efficacy and safety. The product is contraindicated for patients with known hypersensitivity to any component of the formulation and should be used with caution in certain patient groups, such as those with cardiovascular disease or hyperthyroidism. Common adverse reactions may include transient blurred vision, reduced visual acuity, photophobia, superficial punctate keratitis, and mild eye discomfort.
For our patients at Compton Eye Associates, MYDCOMBI’s approval provides a new, efficient, and potentially more comfortable option for pupil dilation during eye exams and certain eye surgeries. We are excited about the possibilities this new treatment brings and are ready to discuss its benefits and suitability for your individual needs.
To learn more about MYDCOMBI and whether it’s a good fit for you, or to explore other eye health solutions, we encourage you to schedule an appointment at our office.