Eyeworld

EW MEETING REPORTER 64 Reporting from the 2018 OIS@ASCRS, April 12, 2018, Washington, D.C. this purpose and, as Dr. Eydelman put it, the first FDA-approved device that "reaches a diagnosis without physician input." Another session took a look at the 20-year history of the femtosec- ond laser in ophthalmology, inno- vation that brought the technology to where it is today, and future, disruptive applications for it. Tibor Juhasz, PhD, Irvine, California, discussed how the femto- second laser works, its early years in ophthalmology, and where he sees it going in the future. Representatives or consultants for several companies spoke about femtosecond laser technologies and current and future applications. Dirk Muelhoff, Carl Zeiss Med- itec, spoke about the VisuMax laser and ReLEx SMILE (small incision lenticule extraction). Nicholas Curtis, LENSAR (Orlando, Florida), discussed how its laser platform was moving back toward making progress for presbyopia treatments in the crystalline lens. Mark Packer, MD, Keranova, described how fem- tosecond laser technology that uses a phase-masked matrix approach could perform incisions and "photo- emulsification" to allow for irriga- tion/aspiration without the need for ultrasound energy and on a single machine without the need to move the patient. George Waring IV, MD, Perfect Lens, discussed the use of a femtosecond laser to perform refrac- tive index shaping on any optical surface, including already implanted IOLs and human tissue. In terms of recent growth rates for the femtosecond laser in oph- thalmology, Stephen Slade, MD, Dallas, said he thinks the growth rate and adoption of this technology are positive. "I'm happy with the rate, and when you add in SMILE and femto flaps, this is the laser, not the exci- mer … not the argon … but this is the laser of our field. This is it," Dr. Slade said. EW Editors' note: The speakers at OIS@ ASCRS have financial interests related to their respective companies. compliant with treatment. Follow- ing Dr. Singh's introduction, he and Thomas Samuelson, MD, Minne- apolis, conducted a panel discussion with Jag Dosanjh, Allergan (Dublin, Ireland), Michael Onuscheck, Alcon (Fort Worth, Texas), Ram Palanki, PharmD, Santen (Osaka, Japan), Jane Rady, Glaukos (San Clemente, California), and Jonathan Talamo, MD, Johnson & Johnson Vision. OIS features 'chat' with the FDA, history of femto and its future The afternoon sessions at the 2018 OIS@ASCRS began with a "fireside chat" between Dr. Link and Malvina Eydelman, MD, Division of Oph- thalmic and Ear, Nose and Throat Devices, U.S. Food and Drug Admin- istration (FDA) Center for Devices and Radiological Health, Washing- ton, D.C. Dr. Eydelman, whose medical specialty is ophthalmology, dis- cussed a variety of topics, from how she came to the FDA to the direc- tion under FDA Administrator Scott Gottlieb, MD, to new programs that the administration has implement- ed. One, which is a couple of years old, Dr. Eydelman said is the early feasibility study program, which she explained is intended to bring innovation back to the U.S. "It allows us to tap people who have a concept for a brand new device … or who have a device but want to try it in a different indica- tion and want to start clinical trials but don't have all the preclinicals done," Dr. Eydelman explained, adding that ophthalmology has been leading efforts in this program in many ways. Another program is the break- through technology designation, which is a little over a year old. This program "revolutionizes" how the FDA's review process can be expedit- ed. The first ophthalmic device to be given this designation—IDx-DR (IDx, Coralville, Iowa), software that uses artificial intelligence to detect diabetic retinopathy—was approved by the FDA recently, making it through the review process to mar- ket in 85 days, Dr. Eydelman said. It is the first FDA-approved medical de- vice to use artificial intelligence for the number of ophthalmologists is estimated to decrease to 17,000, so optometrists will be seeing more of these patients. Better ways to diag- nose and treat dry eye are needed, Dr. Holland said, before highlighting the evolution of modern diagnostics and treatments. Representatives from Kala Phar- maceuticals (Waltham, Massachu- setts), Oyster Point Pharma (Princ- eton, New Jersey), Sight Sciences (Menlo Park, California), and Tear Film Innovations (San Diego) spoke during the session. Following the company pre- sentations, Dr. Holland conducted a panel discussion with Sumit "Sam" Garg, MD, Irvine, California, Preeya Gupta, MD, Durham, North Carolina, and John Sheppard, MD, Norfolk, Virginia. The panelists com- mented on new products to treat dry eye disease, and Dr. Holland asked specifically what they would like to see in the next 5 years. Dr. Gupta said that though osmolarity and MMP-9 testing is available, she would like to have a quantitative method for MMP-9. She added that a more rapid allergy test would be helpful. Additionally, Dr. Gupta said that there are several molecules referred to as biomarkers, and it would be helpful to harness/ assess these molecules with one tiny tear sample. In terms of what is still needed on the treatment side of dry eye disease, Dr. Garg said that what he wants is something affordable, with easy compliance and great effica- cy. Asking patients to use drops or treatment multiple times a day just doesn't work, he added. Dr. Gupta said she would be in- terested in an implantable technolo- gy or something that doesn't require patient compliance. Dr. Sheppard said personalized medicine would be an important de- velopment, and he added that map- ping the patient's phenotype could help determine specific therapy. Kuldev Singh, MD, Palo Alto, California, provided the introduc- tion to a "Spotlight on MIGS," noting that only 25–50% of those with glaucoma are aware that they have the disease; of those who are aware, many are not under care or May 2018 Sponsored by

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