FDA Panel Votes Down VisionCare Eye Prosthetic; Firm To Submit More Data
This article was originally published in The Gray Sheet
Executive Summary
VisionCare Ophthalmic Technologies says it will provide to FDA additional data from its study of the Implantable Miniature Telescope (IMT) as requested by the agency's Ophthalmic Devices Panel
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VisionCare IMT endorsed by panel
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)