VisionCare IMT endorsed by panel
This article was originally published in The Gray Sheet
Executive Summary
Firm's implantable miniature telescope should be approved to treat vision loss associated with age-related macular degeneration, FDA's Ophthalmic Devices Panel recommended in a unanimous 8-0 vote March 27. The panel conditioned its vote on postmarket studies to follow the original pivotal study patients for up to a total of seven to ten years, and evaluate the rate of certain potential adverse events - including corneal edema and corneal transplant - in new IMT recipients. The panel was VisionCare's second go-around after a July 2006 "not approvable" recommendation. Safety concerns include the potential loss of endothelial cell density, which can cause corneal edema. Longer-term follow-up data and a more limited proposed indication contributed to the subsequent positive panel review. The firm proposed a contraindication for patients who do not meet a minimum endothelial cell density threshold and raised its minimum proposed patient age from 55 to 65 years (1"The Gray Sheet" July 24, 2006, p. 8)