Results of Implantable Telescope Trial Published in Ophthalmology Report on Vision and Quality of Life in Patients With End-Stage Age-Related Macular Degeneration -Publication Details Study on Leading Cause of Blindness in Seniors,

Elderly-



    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%
 protocol-specified target).
     "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
 their lives."
     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
 http://www.ophsource.org/periodicals/ophtha/article/PIIS016164200600933X/ab
 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
 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. 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
 2007.
     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 www.visioncareinc.net .
 
 

SOURCE VisionCare Ophthalmic Technologies, Inc.

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