Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

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

You may also be interested in...



VisionCare Macular Degeneration Implant Needs Post-Market Studies – Panel

VisionCare Ophthalmic Technologies' IMT implantable miniature telescope should be approved to treat vision loss associated with end-stage, age-related macular degeneration, contingent upon two post-market studies, according to FDA's Ophthalmic Devices Panel

VisionCare Macular Degeneration Implant Needs Post-Market Studies – Panel

VisionCare Ophthalmic Technologies' IMT implantable miniature telescope should be approved to treat vision loss associated with end-stage, age-related macular degeneration, contingent upon two post-market studies, according to FDA's Ophthalmic Devices Panel

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)

Related Content

UsernamePublicRestriction

Register

MT023798

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel