"The long-term results described in this publication reflect years of technical and clinical development in collaboration with the IMT002 Study Group investigators," said Allen W. Hill, CEO of VisionCare. "We are pleased the safety and efficacy results of our pivotal clinical trial have been reported in highly regarded scientific journals like the AJO. VisionCare looks forward to successfully completing the U.S. regulatory review process."
The results are published in the November 2008 issue of the AJO and available on-line at the journal's web site http://www.ajo.com/current. Citation: Hudson HL, Stulting RD, Heier JS, Lane SS, Chang DF, Singerman LJ, Bradford CA, Leonard RE; IMT002 Study Group. Implantable Telescope for End-Stage Age-related Macular Degeneration: Long-term Visual Acuity and Safety Outcomes. Am J Ophthalmol. 2008: 146; 664-673.
About the Telescope Device
The investigational Implantable Miniature Telescope (IMT(TM) by Dr. Isaac Lipshitz) is designed to be a solution for moderate to profound vision loss due to advanced, end-stage forms of AMD that have no current surgical or medical treatment options. Smaller than a pea, the telescope prosthetic device is implanted in one eye in an outpatient surgical procedure. In the implanted eye, the device renders enlarged central vision images over a wide area of the retina to improve central vision, while the non-operated eye provides peripheral vision for mobility and orientation.
The prospective, multicenter IMT002 Phase II/III trial was designed to
evaluate the safety and efficacy of VisionCare's investigational medical
device in individuals with moderate to profound bilateral central vision
impairment associated with End-Stage AMD. A Premarket Approval (PMA)
application and subsequent PMA amendments have been submitted to the U.S.
Food and Drug
'/>"/>
| SOURCE VisionCare Ophthalmic Technologies, Inc. Copyright©2008 PR Newswire. All rights reserved |