Industry Insider is a timely chat with an ophthalmic industry thought leader.

Yari Mitchell serves as the chief business development officer for AcuFocus, Inc. The company, which she joined in 2010, creates ophthalmic devices using proprietary “small aperture” technology. Using this, AcuFocus created the Kamra inlay, which was sold to CorneaGen (formerly SightLife Surgical) last year and has developed the IC-8 IOL, which received FDA approval to begin an IDE clinical study in November 2018.

Ophthalmology Management: AcuFocus describes itself as “the small aperture company.” Why the focus on this technology?

Yari Mitchell: The small aperture technology has been the core of our business since our founding; we like it as a method of action because it’s a physical principle proven to provide extended depth of focus and help reduce aberration.

Fields such as photography and astronomy have further helped demonstrate this effect, and we’ve seen it work well in vision correction. This has been done with pinhole occluders, which block peripheral light that might interfere with vision; these have been used by optometrists and ophthalmologists since the 1940s to assess a patient’s best possible vision.

We decided to apply this principle to an implantable device, which is what led to the creation of the Kamra inlay and IC-8 IOL.

OM: Is AcuFocus investigating any other applications for small aperture technology?

YM: While we are currently focused on bringing the IC-8 IOL to the U.S. market, we do have a deep portfolio of patents on other applications for small aperture, both as implantable devices and used in combination with other optical systems. AcuFocus has a number of projects in process, but we can’t go into detail about our pipeline at this time.

I can say that we have been studying how small aperture can help correct astigmatism. Based on patients treated in Europe and Australia, our lens has shown to be effective for people with irregular astigmatism, whether it stems from natural formation, keratoconus or corneal scarring. This group of patients, which we estimate to be 11% of global cataract surgery patients, does not do well with a diffractive optic; however, if you use a small aperture IOL, we see patients gain a range of vision as well as relief from dysphotopsias, like halos and glares, that result from their irregular corneas.

In addition, we are seeing positive results for the IC-8 outside the U.S., in that it can improve monovision outcomes. These monovision patients experience the same near and intermediate benefit while maintaining distance binocularly with less demand for anisometropia.

OM: AcuFocus received IDE approval from the FDA this past November to conduct a pivotal trial of the IC-8 IOL. Can you share updates from that trial?

YM: After the IDE approval in November, we had our first procedure just a month later, and we credit our team for completing that in such a short time frame.

We’re currently in our enrollment phase for the trial and expect that to close soon. Subjects will be followed for one year.

We are on track with our timeline and anticipate bringing the IC-8 IOL to the U.S. market around Q4 2020 or Q1 2021.

OM: Can you tell us the responsibilities of your current role?

YM: At AcuFocus, we believe small aperture optics fills an important gap in vision correction options. Our focus has, and continues to be, improving outcomes for underserved patient populations, with therapies uniquely designed to address their individual needs.

As the chief business development officer, my primary role is to drive both global commercialization for the IC-8 lens and lead our enterprise-wide business strategy. I’m “partnered at the hip” with AcuFocus’ CEO, Al Waterhouse, in managing the direction of the organization and its strategic partnerships, as well as working closely with our physician advisors and KOLs. OM