VisionCare macular degeneration implant rejected by panel

FDA's Ophthalmic Devices Panel votes 10-3 against recommending FDA approval of VisionCare's IMT implantable miniature telescope for age-related macular degeneration (AMD) at a July 14 meeting in Gaithersburg, Md. Panel members cited concerns over endothelial cell density (ECD) loss associated with device use. The firm's 218-patient pivotal trial failed to meet its primary safety endpoint of a mean ECD decrease of < 17%. The mean decrease in ECD observed in the study was 25.3% at one year. Panel members suggested that submission of additional pivotal trial follow-up data on ECD loss, as well as morphometric data, would be needed to establish safety of the device. Efficacy data showed that 90% of implant patients improved two lines or more in either near or distance best corrected visual acuity after 12 months. Made of quartz glass, IMT is designed to work like a camera's telephoto lens, magnifying images over a wide area of the retina to improve central vision. The firm is seeking PMA approval for patients over age 55 with bilateral, stable, moderate-to-profound central vision impairment due to AMD...