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Eyenovia, Iantech making strides in microdosing and cataract markets
Microdosing technology delivers more accurate levels of medication, while the miLOOP device features a new method to break up cataracts.
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The miLOOP device from Iantech Technologies and microdosing technology from Eyenovia will provide ophthalmologists with new methods to break up dense cataracts and deliver precise amounts of medication to patients.
Sean Ianchulev, MD, MPH, founder of both Iantech Technologies and Eyenovia, is the co-creator of the miLOOP, a micro-interventional lens fragmentation device designed to achieve full-thickness lens fragmentation for any grade cataract and reduce or eliminate energy delivered to the eye during the procedure.
“Now we can break from the smallest of the soft cataracts to the very hard ones without any energy. We fragment it in a completely different way. When you chop, you chop from the inside out in cataract surgery with the phacoemulsification laser and you deliver energy. When you do inside out, you create tension on the capsule and you see problems in pseudoexfoliation and other complex cases. With the miLOOP, we fragment everything without energy from the outside in, and it cuts everything in between,” he said.
The Global Health Investment Fund invested significant capital into the company to further research and development and commercial efforts for miLOOP, he said.
In 3 to 4 months, Ianchulev said Iantech Technologies will likely unveil the triLOOP, a triple-loop micro-interventional device that will remove segments without the use of phacoemulsification.
“We’re basically developing a micro-interventional kit of two to three pen-like devices that are disposable that can eliminate energy in phaco for cataract surgery. Cataract surgery hasn’t changed much in 50 years. This micro-interventional technology is in the sweet spot of being able to break something inside the eye and take it out without any energy,” he said.
With Eyenovia, Ianchulev helped develop new microdosing technology, which uses piezo injection technology to topically print medications to the ocular surface and give more accurate dose levels than a dropper or a pipette, he said.
Eye therapies that use a dropper to topically administer an ocular drug deliver a dose about 400% more than the eye can hold. Overdosing of both preservatives and medications can lead to serious adverse events for patients, he said.
Micropipettes can deliver doses as small as 3 µL, but they are long and harder to control than droppers, so the medication cannot be practically applied, he said.
“It turns out, after 4 years of development, we figured out how to do it and deliver it right on the ocular surface using high-precision piezo printing — an approach adapted from inkjet printing where targeted microfluidic ejection can be focused on a single pixel. Piezo printing of medication is very fast and can achieve horizontal delivery in less than 80 milliseconds to beat the blink reflex,” Ianchulev said.
In a recent phase 2, masked, nonrandomized crossover study evaluating pupil dilation with topical phenylephrine, eyes dilated with 10% formulation by the micro-dosing method produced the same dilation at 75 minutes compared with eyes dilated using the conventional method. With a 2.5% formulation, eyes dilated with the micro-dosing technology showed superior results compared with the conventional method, Ianchulev said in a presentation at the American Academy of Ophthalmology meeting in New Orleans.
A phase 3 study will likely be completed by the end of 2018 and should provide data Eyenovia can submit to the FDA for approval, he said.
“We have multiple programs, and it will all be in the execution. That’s the beauty of technology. It can deliver new therapeutic innovations, can inflect the therapeutic index of many existing drugs, and it can add digital health, compliance monitoring and personalized treatments for patients, which is very unique,” he said. – by Robert Linnehan
- References:
- GHIF and Visionary Venture Fund back Iantech. https://www.pehub.com/2017/07/ghif-and-visionary-venture-fund-back-iantech/. Published July 13, 2017. Accessed Nov. 27, 2017.
- Ianchulev S. High precision microdose delivery of topical medications. Presented at American Academy of Ophthalmology annual meeting; Nov. 11-14, 2017; New Orleans.
- For more information:
- Sean Ianchulev, MD, MPH, is professor of ophthalmology and director of innovation and technology at New York Eye and Ear Infirmary of Mount Sinai. He can be reached at New York Eye and Ear Infirmary of Mount Sinai, 310 E. 14th St., New York, NY 10003; email: tianchul@yahoo.com.
Disclosure: Ianchulev reports he is the founder of Eyenovia and Iantech Technologies; the chairman of the board for Iantech Technologies and on the board of Eyenovia; and the CEO of Eyenovia.