(PRESS RELEASE) BELLEVUE, WA — Innovega Inc. (“Innovega” or the “Company”), a developer of stylish, lightweight wearable displays that feature a high-resolution, panoramic-field-of-view system for medical, consumer, and industrial application, announced a milestone achievement in the clinical development of its iOptik contact lens. The company received Institutional Review Board (IRB) approval of a protocol for single exposure of the iOptik contact lens and prototype display eyewear simultaneously for up to six hours, allowing augmented reality subject experts to report their observations when viewing media from Innovega’s eMacula near-eye display eyewear.
“This IRB approval follows completion of all pre-clinical testing, including the biocompatibility of our fourth-generation disposable soft contact lens with an embedded oxygen-permeable, flexible, and sterilizable light polarizing filter, and allows us to advance into human testing,” said Dr. Jerome Legerton, co-founder and chief clinical and regulatory officer of Innovega. “This feasibility study allows us to gather input from performance observations of clinical and technical experts and complements our six previous feasibility studies conducted at The Ohio State University.”
Approval of the single-exposure clinical study enables demonstration and understanding of the significant advantages in placing the optics of a wearable display on or in the eye. The early optical modeling conducted by Professor Schwiegerling at the University of Arizona demonstrated the potential for full visual acuity, wide field of view, and long depth of field with Innovega’s contact lens optics.
“We may now allow augmented reality experts to observe the eMacula system performance during an extended duration while we advance our clinical development toward FDA market clearance,” said Dr. Legerton. “The observations will provide valuable feedback to assist Innovega in refining the reference designs for the display eyewear that will be used with the iOptik contact lens. We continue to see the market need as augmented, mixed, and virtual reality companies struggle to produce lightweight, stylish eyewear that deliver panoramic field of view and eyestrain-free viewing.”
The Company expects to receive additional IRB approvals that will allow for further feasibility clinical studies at The Ohio State University. It is anticipated that the results will be available early fourth quarter of 2019. Each of these feasibility studies will provide valuable data for the design of the subsequent pivotal Phase III studies. The first of the pivotal studies will be a 510(k) study involving the contact lens material only, while the second will be for the iOptik contact lens for viewing eMacula near eye display eyewear.
