Eyeworld

EW REFRACTIVE 58 June 2017 "That whole process, depending on how it's managed, can take 3 years," he said. Dr. Kim sees EV06 as a possible complementary approach to PRX- 100, which works immediately. "It might be a nice complement to that approach," he said. Dr. Kim is excited about the potential for such pharmacologic approaches. With close to 2 billion presbyopic people, the market is huge, he stressed. "It's a lifestyle enhancement product that will be completely elective," Dr. Kim said, and he views the cost as something patients will readily accept, especial- ly when considering the benefits. EW Editors' note: Dr. Lindstrom has financial interests with Novartis. Dr. Kim has financial interests with Presbyopia Therapies. Contact information Kim: terry.kim@duke.edu Lindstrom: rllindstrom@mneye.com During the 90-day prospective randomized trial, 75 patients were administered either the EV06 drop or placebo four times a day, Dr. Lindstrom said, adding that 50 of the patients were treated with the EV06 and 25 served as controls. Those included were ages 45 to 55. At day 91, investigators saw one line of near vision improvement for 84% of those who received EV06 and 52% of those who received placebo. There were two lines or more of im- provement in near vision for 53% of those who received the drop versus just 22% in the placebo group, Dr. Lindstrom reported. A three-line or more improvement was seen in 22% of EV06 patients, and 12% saw a four-line or more improvement. "At every one of these points, it was statistically significant," Dr. Lindstrom said. The pretreatment near vision was 20/54 on average and the post-treatment was 20/28, he con- tinued. "This is about a two- to 2.5- line improvement in vision, which is quite meaningful," Dr. Lindstrom said. In addition, there's a possibility that the drop can be used to help reduce the progression of cataracts, he explained, adding that the same mechanism of action involved in crosslinking is involved in the devel- opment of cataracts. "Those studies need to be done, but from a patho- physiology perspective it's logical that this drop might also retard the progression of cataract," Dr. Lindstrom said. With both presby- opia and cataracts, use of EV06 may lead to a mild reversal in the condi- tion and a reduction in the progres- sion. "At 45 you have some level of dysfunctional lens syndrome where your lens is becoming inelastic and slightly opaque and there is a loss of contrast," he said. "Taking a drop like this might make you the way you were at 35, but not at 10." In general, a good way to think about the drop is that it will make your vision like it was when you were about 10 years younger, Dr. Lindstrom noted. EV06 could also be used to- gether with pupil constriction, Dr. Lindstrom pointed out. As patients get older, they could use the miotic drop to boost the waning effect of EV06 if they don't want to wear their reading glasses. EV06 could be used in conjunc- tion with certain types of surgery employed to correct refractive error, such as LASIK, PRK, and SMILE, Dr. Lindstrom said. He finds one of the things that keeps some patients from choosing LASIK, particularly mild myopes, is the concern that they may be trading distance glasses for reading ones. "We'll be able to say to these patients, 'We can do the surgery and if you take this drop, you won't need the readers, at least until you're 60. Then hopefully we will have a high-quality extended depth of focus lens to transition into as a goal to be spectacle indepen- dent,'" Dr. Lindstrom said. The next steps with EV06 are Phase 2 and 3 FDA clinical trials with a larger number of patients. Assuming that safety and efficacy holds up, Dr. Lindstrom think FDA approval could take just a few years. Nonsurgical continued from page 56

• Blank Page
• Blank Page (1)