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<0.0001)
-- Study eyes receiving the 3X model telescope prosthesis showed an
average VA improvement of 3.6 lines at 2 years compared to 0.5 lines in fellow
eye controls (p<0.0001)
-- Median VA improvement was over 3 lines better in telescope-implanted
eyes versus corresponding fellow eyes that underwent cataract surgery and
intraocular lens implantation (p<0.0002)
Safety:
-- Loss of 3 lines (15 letters) or more of VA occurred in 0.6% of
telescope-implanted eyes versus 7.5% of fellow eye controls (p=0.0013)
-- Corneal endothelial cell loss was 27% two years after surgery, versus
20% through 3 months and 25% through 12 months
"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 Administration and are currently under regulatory review.
About Macular Degeneration
Macular degeneration is a disorder of the central retina, or macula, which
is responsible for detailed vision that controls important functional visual
activities like reading, recognizing faces, and watching television. According
to the National Eye Institute over 1.7 million Americans over age 50 suffer
mild to profound vision loss from advanced AMD, which frequently culminates as
end-stage AMD (visual impairment due to untreatable advanced AMD). Patients
affected in both eyes often experience a loss of independence, social
interaction, and have difficulty with activities of daily living requiring
detailed vision. Approximately half of the individuals living with advanced
AMD are affected in both eyes.
About VisionCare
VisionCare Ophthalmic Technologies, Inc., headquartered in Saratoga, CA is
a privately-held company focused on development, manufacturing, and marketing
of visual prosthetic devices. The Implantable Miniature Telescope was invented
by company founders, Isaac Lipshitz, M.D., and Yossi Gross. Information on
VisionCare can be found at http://www.visioncareinc.net.