The U.S. Food and Drug Administration (FDA) has approved ReVision Optics, Inc.’s Raindrop near vision inlay, a corneal inlay for the surgical correction of presbyopia.
The near vision inlay is indicated to improve near vision by reshaping the anterior curvature of the cornea in presbyopic patients who have emmetropic refractions (+1.00 D to -0.50 D).
Results from the study submitted to the FDA in ReVision Optics’ premarket approval application showed clinically significant improvement in near visual performance, including:
- Average uncorrected near visual acuity improved by 5 lines on a standard eye chart (at 40 cm) in the treated eye. There was no loss in binocular distance vision
- 98 percent of patients achieved uncorrected near visual acuity of 20/40 or better and 88 percent of patients achieved 20/25 or better at 24 months in the treated eye
- The mean uncorrected visual acuity for both eyes exceeded 20/20 at all distances — near, intermediate, and distance
The company anticipates commercializing Raindrop in the U.S. through a direct field salesforce beginning in the third quarter of 2016.
The near vision inlay approval was based on the results of 373 patients treated at 11 investigational sites in the U.S. Patients in the clinical study experienced an average improvement in near vision of 5.0 lines between their preoperative examination and the 24-month post-operative follow-up visit.
Although not an endpoint of the clinical study, patients also experienced an average improvement in intermediate vision of 2.5 lines between their preoperative examination and the 24-month post-operative follow-up visit.
The improvements were maintained throughout all study follow-up periods and were included in the premarket approval application. There was no change in distance vision binocularly, but patients did experience an average loss of 1.2 lines in distance vision in the treated eye. FDA considers a change of ≥2 lines to be clinically significant.
Information provided in the application submission confirmed that the inlay is removable and that patients return to their baseline (preoperative) visual acuities if the device is removed. For Raindrop, refractive stability was achieved at six months unlike some presbyopic corneal inlays that may take up to 18 months, or longer, to achieve refractive stability.
The near vision inlay is placed in the cornea of the non-dominant eye during a 10-minute procedure. The inlay is comprised of approximately 80 percent water and has a refractive index very similar to the cornea. It is transparent and therefore does not restrict the amount of light reaching the retina. The reshaping of the anterior curvature of the cornea improves near vision.
IN addition to FDA approval, the company received CE Mark authorization for the European Union, license approval by the Ministry of Food and Drug Safety (South Korea), approval by the Therapeutic Goods Administration (Australia), and registration with the Medicines and Medical Safety Authority (New Zealand). Other country-specific registrations are pending.