Long-Term Results of VisionCare's Implantable Telescope for End-Stage Macular Degeneration Published in the American Journal of
November 05 2008 - 4:00PM
PR Newswire (US)
- Report shows three-line average visual acuity improvement
maintained at two years - SARATOGA, Calif., Nov. 5 /PRNewswire/ --
VisionCare Ophthalmic Technologies, Inc., a developer of advanced
visual prosthetic devices for individuals with age-related macular
degeneration (AMD), today announced that the American Journal of
Ophthalmology (AJO), a premier peer-reviewed medical journal, has
published two-year results from the Phase II/III IMT002 trial
showing substantial visual acuity improvement in End-Stage AMD
patients. The study device, a first-of-kind implantable telescope,
has received CE Mark approval in Europe and is currently
investigational and under regulatory review by the U.S. Food and
Drug Administration. The publication details the two-year safety
profile of the device and found rates of cornea endothelial cell
loss, while higher than conventional small-incision anterior
segment eye surgery, were consistent with anterior segment
procedures employing more similar incision sizes required for
telescope implantation. "The published data show improved visual
acuity in end-stage AMD patients that was maintained over two years
-- a three-line improvement that we have previously shown makes a
real impact on our patients' independence and quality of life,"
said Henry L. Hudson, M.D., lead author for the IMT002 study and
retina specialist at Retina Centers, P.C. in Tucson, AZ. "These
findings are important because vision loss from end-stage AMD
profoundly affects both the daily activities and social well-being
of many older Americans." "The data presented in AJO confirm the
effectiveness of the AMD telescope prosthesis and the long-term
safety profile of the device," stated R. Doyle Stulting, M.D.,
Ph.D., professor of ophthalmology at Emory University in Atlanta
and study coauthor. "Key indicators of corneal health and
diagnostic verification of device placement substantiate earlier
findings that risks of surgery are outweighed by the benefits the
improved vision brings to these patients' lives." "We hope these
published results will lead to a new treatment option for patients
with end-stage AMD," commented Stephen S. Lane, M.D., the trial's
medical monitor who is an adjunct professor of ophthalmology,
University of Minnesota, and in private practice at Associated Eye
Care, Stillwater, MN. "Across the 28 centers in the study, we were
able to provide a novel approach for patients whom we have not had
any solutions to improve visual acuity in a functional way."
End-Stage AMD occurs when the macula in each eye is irreversibly
degenerated and no longer provides detailed central vision required
for common everyday activities such as reading, recognizing people
and facial expressions, or watching television. End-Stage AMD is
characterized by central scotomas, or blind spots, in both eyes
that cause images in the central visual field to be unrecognizable
or not visible at all. AMD is the leading cause of irreversible
blindness in the United States and other developed countries.
Highlights from the AJO publication on the prospective, multicenter
IMT002 study are summarized below. Efficacy: -- 60% of
telescope-implanted study eyes gained 3 lines (15 letters) or more
of visual acuity (VA) at 2 years after implantation versus 10% of
fellow eye controls (p