ReVision Optics today released data from a trial of its Raindrop implantable presbyopia-correcting corneal inlay, touting high rates of near visual acuity in treated patients versus untreated patients.
Data from the 344-patient trial was presented at the 2015 Opthalmology Innovation Summit in Las Vegas last month, the company said.
“We are clearly seeing outstanding visual results with the Raindrop inlay, with excellent near, intermediate and distance function. This improved vision has resulted in very high satisfaction rates with 87% of patients reporting that they were satisfied at 2 years post treatment. As previously announced, we have received notice from the FDA that our PMA submission is fileable and we are having productive interactions with the Agency. We believe that this puts us on track for an advisory committee meeting in the 2nd quarter of 2016 and an approval in late 2016,” CEO John Kilcoyne said in a press release.
ReVision said data from the trial showed 88% of post-treatment patients had near visual acuity of greater than or equal to 20/25 in the treated eye while none of the patients had preoperative near visual acuity of ≥20/25.
The study reported that 76% of post-treatment patients had intermediate visual acuity of ≥20/25 in the treated eye, as compared with less than 18% of preoperative patients. All post-treatment patients in the trial reported binocular distance visual acuity of ≥20/25.
In a 2nd presentation, Dr. Douglas Koch of Houston’s Baylor College of Medicine said patients showed good near vision at 3 months post-treatment with a mean visual acuity of 20/25 and an average gain of 4 lines in near visual acuity, with a slight loss in distance vision in the treated eye, the company said.
Distance and near binocular task performance was up across all groups in both good and dim light, the company said.
Results from the study were published in the August issue of the Journal of Cataract Refractive Surgery.