Presbia PLC reported certain interim data from its U.S. staged pivotal clinical trial. Through November 30, 2016, 421 subjects have undergone insertion of the Company's microlens during the staged pivotal clinic trial that the Company is performing to obtain the clinical data required to enable the Company to obtain pre-market approval from the FDA. Currently, the Company is 24 months into its 3-year pivotal study and anticipates submitting data to the FDA in September 2017. To date, 100% of the subjects have passed through the 12 month post-operative visit. Data (representing 100% of the study cohort and excluding subjects who explanted the Microlens or did not return for scheduled trial visits and considered lost to follow-up) made available to the Company indicates that: Subjects gained an average of 5 lines of uncorrected near visual acuity (the ability to see close objects without prescription enhancement) in treated eyes, Approximately 83% of subjects achieved 20/40 or better uncorrected distance vision in treated eyes and there was little to no change in binocular uncorrected distance vision, and Approximately 98% of subjects achieved 20/40 or better best corrected distance vision in the treated eyes and there was little to no change in binocular best corrected distance vision. Presbia Flexivue Microlens is designed to take advantage of binocular vision as most patients fuse both images in the brain. The brain filters bad images, thus, resulting in accepting the best images.