Microdose Eye Droppers Cut Adverse Events, Costs

Tsontcho Ianchulev, MD, MPH

A microdose delivery system for eye drop therapies may be an improvement in treatment efficacy and costs.

A study of microdose eye droppers, presented at the 121st Annual Meeting of the American Academy of Ophthalmology (AAO 2017) in New Orleans, LA, found that the dosing technology may better serve patients with dry eye (DE) and glaucoma.

A team of researchers from the New York Eye and Ear Infirmary of Mount Sinai showed that a microdose delivery system, while delivering less than 4 times the amount of drug as a conventional eye dropper, achieved comparable treatment in patients.

The treatment — phenylephrine, a common drug used by ophthalmologists to dilate the pupil in order to examine the back of the eye — was administered to 24 patient eyes with a microdose eye dropper, versus a control group treated with a standard size eye dropper.

The studied microdose eye dropper was a hand-held system designed to deliver single-digit microliter doses to the surface of the eye within 80 milliseconds — faster than a blink.

To demonstrate feasibility, pharmacodynamic equivalence, and topical and systemic safety, researchers measured patient eyes’ systemic plasma levels and any topical adverse events (AE).

Researchers noted that commonly-used eye droppers actually administers doses 4 to 5 times larger than the maximum volume a human eye can hold. Overflow treatment often drains through the ducts in the corner of the eye, wasting medication with every dose.

The oversized doses can also lead to AEs when absorbed outside of the eye. Some topical medications change patient heart beats when overdosed, and toxic preservatives cause redness, itching, irritation, and further cases of DE.

The microdose administration gave patients a dose 75% to 80% less than that of the conventional eye dropper, according to the study. As a result, microdose patients had fewer lower levels of the topical drug in their bloodstream and fewer rates of AE (8%, versus 66% in control patients), while retaining about 90% of treatment efficacy.

Tsontcho Ianchulev, MD, MPH, Professor of Ophthalmology at the Icahn School of Medicine at Mount Sinai, and director of the Ophthalmic Innovation Technology Program at New York Eye and Ear Infirmary of Mount Sinai Hospital, believes health care officials have found a viable technology to “transform the 100-year old eyedropper paradigm.”

Additional clinical trials to evaluated the technology’s treatment of glaucoma and pupil dilation is expected to begin in the next year, Ianchulev said. He believes the method could expand to treatments for DE, allergic eye disease, and infections.

At its ongoing clinical rate, Ianchulev projects the first micro-therapeutic formulations could be on the market by 2020.