SARATOGA, Calif., Nov. 1 /PRNewswire/ -- VisionCare Ophthalmic
Technologies, Inc., a developer of advanced visual prosthetic devices for
the treatment of age-related macular degeneration (AMD), today announced
that results from the Phase II/III clinical trial of the investigational
Implantable Miniature Telescope (IMT(TM) by Dr. Isaac Lipshitz) have been
published in the November issue of Ophthalmology, the official journal of
the American Academy of Ophthalmology. The publication documents a
potential new treatment model for an unmet medical need -- irreversible
vision loss due to bilateral end-stage AMD.
The Ophthalmology article entitled "Implantable Miniature Telescope for
the Treatment of Visual Acuity Loss Resulting from End-Stage Age-Related
Macular Degeneration," details the results from the IMT002 trial which
enrolled 217 patients at 28 U.S. investigational sites. Patients entering
the trial had severe vision loss due to the characteristic central blind
spot caused by end-stage macular degeneration. The publication reports 90%
of patients met or exceeded the protocol-specified primary efficacy
endpoint of visual improvement, defined as a 2-line gain in either distance
or near vision on the study eye chart. The protocol stated the endpoint
would be achieved if at least 50% of patients met this target.
"This is truly a breakthrough because it is the first clinical trial to
show the potential for improved vision and quality of life specifically in
patients with bilateral, irreversible AMD," said Henry L. Hudson, M.D.,
lead author of the IMT002 study publication and retina specialist at Retina
Centers, P.C. in Tucson, AZ. "From an efficacy standpoint, we hoped that
half of this study population with untreatable forms of AMD could achieve
at least a 2-line visual acuity gain. The results surpassed our
expectations because ninety percent achieved the efficacy endpoint, and,
furthermore, over two- thirds of patients improved by at least three lines
and one-quarter improved by at least five lines in distance vision."
At 1 year after the telescope implantation procedure, 67% of patients
achieved a 3-line (doubling of vision) or greater improvement in their
study eye distance visual acuity, compared with 13% of unimplanted fellow
eye controls. Approximately 25% of telescope-implanted eyes achieved a
5-line or greater improvement in visual acuity, compared with 2% of fellow
eyes. Loss of 3 lines or more was encountered in 1.6% of implanted eyes,
compared with 3.1% of fellow eyes. Secondary efficacy outcome measures
suggest improvement in patients' vision-related quality of life and
activities of daily living. On the National Eye Institute 25-item Visual
Function Questionnaire, patients improved significantly from baseline
(range 7 to 14 points) in 7 of 8 relevant vision-specific and psychosocial
subscales, including General Vision, Social Functioning, and Dependency.
Corneal endothelial cell density, a safety endpoint, was reduced 20% from
preoperative at 3 months and 25% at one year (compared with the 17%
"In an end-stage AMD population, the indicated improvements in this
study are substantial compared to risks of surgery," commented R. Doyle
Stulting, M.D., Ph.D, professor of ophthalmology at Emory University in
Atlanta, and study coauthor. "For patients with this level of visual
impairment, the ability to be less dependent on others and to reclaim even
a few of the activities they once enjoyed could make a real difference in
Patients enrolled in the study were at least 55 years of age and had
central vision loss caused by disciform scars (end-stage wet AMD) or
geographic atrophy (advanced dry AMD). Exclusion criteria included active
choroidal neovascularization (wet AMD) or treatment of wet AMD in the
preceding six months. Patients with early-stage AMD, mildly visually
impairing AMD, or unilateral affection were not eligible.
"This study is important in the current era of new retinal treatments
for patients with macular disease," said study coauthor Jeffrey S. Heier,
M.D., assistant professor at Tufts University School of Medicine and in
private practice at Ophthalmic Consultants of Boston. "Despite the
unprecedented progress we have made in treatments for wet AMD over the past
decade, there are still no medical or surgical options available for
patients with end-stage wet AMD or geographic atrophy. The results of this
study suggest the potential for meaningful outcomes for a patient
population for which we've had virtually no options to improve vision."
The IMT002 trial was a prospective, open-label, multicenter clinical
trial conducted under an investigational device exemption from the U.S.
Food and Drug Administration (FDA). Patients averaged 76 years of age. The
telescope prosthesis was generally well tolerated in the eye. 206 of the
217 enrolled patients had the device successfully implanted in their study
eye, while 11 patients received a standard intraocular lens due to an
aborted procedure. The most common complications or adverse events included
transient intraocular pressure, transient corneal edema, iris prolapse, and
inflammatory deposits on the device. There were 2 cases of corneal
decompensation. The published results can be found online at
str act .
"Despite the endothelial cell loss from surgery, we believe that
corneal health was maintained," said 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.
"There was a significant correlation between postoperative cell loss and
the level of corneal edema on the first postoperative day. Therefore, it
appears that the majority of cell loss was due to the impact of the
surgical procedure. Stabilization of cell density three to twelve months
after surgery was consistent with what we'd expect after large-incision
intraocular surgery. While the techniques required to implant the device
are well within the skill set of anterior segment surgeons, a surgeon
training program will be utilized to address the risk of acute endothelial
cell density loss during implant."
About the Telescope Prosthetic Device
The investigational Implantable Miniature Telescope (IMT(TM) by Dr.
Isaac Lipshitz) is designed to be a permanent 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
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. Based on data included in the
published results and from ongoing patient follow-up, VisionCare filed a
Premarket Approval (PMA) application for the telescope prosthesis. The PMA
submission sought market approval for the treatment of central vision loss
due to advanced, irreversible forms of AMD. Subsequent to a July 2006 FDA
Ophthalmic Devices Advisory Panel meeting, FDA issued a letter to
VisionCare citing deficiencies in the application that must be addressed to
place the regulatory submission in approvable form. The issues primarily
relate to ascertaining if reduction in corneal endothelial cell density is
due to endothelium remodeling or other factors, and determining the
contribution of cataract removal to the improvement in visual acuity. No
additional clinical investigations have been requested. VisionCare
currently projects submitting a response to FDA in the first quarter of
2007. Assuming no significant additional analyses or clinical data are
required, the Company projects regulatory approval in the second half of
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.
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 www.visioncareinc.net .
SOURCE VisionCare Ophthalmic Technologies, Inc.