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What possible FDA approval in 2019 do you believe will have the most impact on ophthalmology?
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Improved ergonomics during surgery
As we continue to have innovation and new ways of approaching the same problems, whether medical or surgical, having new techniques in the clinic and operating room could be groundbreaking for eye surgeons.
The first possible approval is Ngenuity (Alcon) for anterior segment surgery. The ability to perform heads-up surgery as well as have 3-D imaging of tissues may allow for improved operating room ergonomics for the surgeon as well as better visualization of tissues. Ophthalmologists spend many hours of their careers sitting at a microscope, which can have potential orthopedic implications after many years of operating. Changing the positioning in the way in which we operate may preserve our orthopedic health.
In the past year and a half, as I have incorporated small incision lenticule extraction (SMILE) into practice, it has been a very exciting time to grow refractive surgery at Mass Eye and Ear and in the Boston area. Since October, after the FDA approved astigmatism correction (0.75 D to 3 D), I am now able to offer SMILE to approximately 90% of my laser vision correction candidates. Currently, an Army study is underway evaluating SMILE for lower levels of myopia, less than 1 D spherical equivalent. Being able to treat low levels of myopia and astigmatism with SMILE could also have a significant impact on both the refractive market as well as postoperative refractive and cataract patients who need enhancements.
Kathryn M. Hatch, MD, is an OSN Technology Board Member. Disclosure: Hatch reports she is a consultant for Zeiss.
Presbyopia-correcting drops
The most impactful possible FDA approval in 2019 will be one, if not all, of the presbyopia-correcting drops that are currently under investigation. There are several out there that I know about. They are not FDA approved yet, but by being able to help our patients with presbyopia control, that will be a huge impact. Presbyopia is one of the harder problems to solve, and we have seen surgical options on the market, but there have been several issues with some of the devices, including one being pulled from the U.S. market due to safety concerns.
Having a simple way for patients to treat their presbyopia at least temporarily will not only help patients but could also even advance further awareness of the specialty of presbyopia correction and hopefully even advance more technologies for surgical correction down the road.
There are three companies working on drops right now: Alcon’s EV06 drop, Allergan has two drop candidates, AGN-199201 and AGN-190584, and Presbyopia Therapies’ Liquid Vision (PRX100 ophthalmic solution). The Allergan and Presbyopia Therapies drops are miotic agents designed to constrict the pupil and increase focus. The Alcon drop, however, is designed to break disulfide bonds and help with the accommodative component of the lens.
These are a few different technologies that would be a huge game changer for not only patients and doctors, but hopefully open doors for other new technologies as well.
Jennifer Loh, MD, is an OSN Technology Board Member. Disclosure: Loh reports she is a consultant for Allergan.