July 25, 2016 6:19 PM ET

Healthcare Equipment and Supplies

Company Overview of ReVision Optics, Inc.

Company Overview

ReVision Optics, Inc. develops optical solutions for the treatment of presbyopia. It offers Raindrop Near Vision Corneal Inlay, a refractive surgery solution for near vision lost by the eye’s natural aging process. The company markets in products in the United States, Europe, Canada, Australia, and Japan. The company was formerly known as IntraLens Vision, Inc. and changed its name to ReVision Optics, Inc. in October 2005. ReVision Optics, Inc. was founded in 1996 and is based in Lake Forest, California.

25651 Atlantic Ocean Drive

Suite A1

Lake Forest, CA 92630-8835

United States

Founded in 1996

Phone:

949-707-2740

Fax:

949-707-2744

Key Executives for ReVision Optics, Inc.

Chief Executive Officer, President and Director
Age: 56
Co-Founder
Age: 72
Chief Financial Officer
Vice President of Operations
Chief Compliance Officer and Vice President of Regulatory Affairs & Quality Assurance
Age: 58
Compensation as of Fiscal Year 2016.

ReVision Optics, Inc. Key Developments

ReVision Optics, Inc. Receives FDA Approval for the Raindrop Near Vision Inlay

ReVision Optics, Inc. announced receipt of U.S. Food and Drug Administration (FDA) approval for the Raindrop Near Vision Inlay, a novel corneal inlay for the surgical correction of presbyopia. The Raindrop 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 (PMA) 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% of patients achieved uncorrected near visual acuity (UCNVA) of 20/40 or better and 88% of patients achieved UCNVA of 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 Raindrop 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. These improvements were maintained throughout all study follow-up periods and were included in the PMA. 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. The Raindrop Near Vision Inlay is placed in the cornea of the non-dominant eye during a 10-minute procedure. The Raindrop is comprised of approximately 80% 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. The Raindrop Near Vision Inlay has received approval by the U.S. Food and Drug Administration, authorization to affix the CE Mark 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).

Revision Optics, Inc. Announces Results from Ongoing Phase III U.S. FDA Clinical Study of its Raindrop Near Vision Inlay for Treatment of Presbyopia

ReVision Optics, Inc. announced that results from its ongoing Phase III U.S.FDA clinical study evaluating the Raindrop Near Vision Inlay for the treatment of presbyopia show significantly improved near visual performance and produced a 92% rate of satisfaction among study subjects one year following the procedure. Highlights of the one-year post-treatment outcomes are: Average uncorrected near visual acuity improved by 5 lines on a standard eye chart in the treated eye. There was no loss in binocular distance vision; 93% of subjects achieved uncorrected near visual acuity of 20/25 or better in the treated eye; and The mean uncorrected visual acuity for both eyes exceeded 20/20 at all distances with no loss in contrast sensitivity.

ReVision Optics, Inc. Presents at Canaccord Genuity 2015 Medical Technology & Diagnostics Forum, Nov-19-2015 08:00 AM

ReVision Optics, Inc. Presents at Canaccord Genuity 2015 Medical Technology & Diagnostics Forum, Nov-19-2015 08:00 AM. Venue: Westin Grand Central, New York, New York, United States.

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