October 30, 2005.
Israel 21C, CA.
For 65-year-old Phillip A., sitting and doing the daily crossword puzzle was one of the day's pleasures. But a couple years ago, his vision began to blur at a steady pace, and not only was he unable to read the paper, he also had to stop driving.
Phillip is one of the over 8 million Americans who suffer from age-related macular degeneration (AMD) - 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 culminates as end-stage 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.
Until now, older people like Phillip who are afflicted with the untreatable end-stage form of AMD have not had much hope. But thanks to a device called the Implantable Miniature Telescope (IMT) invented by Israeli doctor Isaac Lipshitz, not only can Phillip regain hope, but he also has a clearer future in sight.
VisionCare Ophthalmic Technologies, Inc. - the company Lipshitz and his partner Yossi Gross founded almost 10 years ago - recently completed Phase II/III trials of the IMT in patients with advanced forms of AMD, and the results point to a revolution in the potential treatment of the ailment.
Ninety percent (172/192) of patients in the US-conducted trial met or exceeded the study's protocol-specified visual acuity endpoint: a 2-line improvement in either distance or near best-corrected visual acuity (BCVA). The study protocol required at least 50% of patients achieve this target.
One-year efficacy data from the prospective, multicenter trial showed patients had a mean improvement of over 3 lines on the ETDRS (Early Treatment of Diabetic Retinopathy Study) chart in both distance and near BCVA in the study eye.
In simpler language, the IMT drastically improved the patients' vision, and the results have paved the way for pending approval of the telescope implant by the FDA.
"The trials were conducted at 28 sites in the US, and the results were better than our expectations and better than the FDA's expectations," Eli Aharoni, Visioncare's general manager told ISRAEL21c. "It shows that the IMT can magnify an image up to three times on the retina, and now we have very good evidence of how effective the device is."
According to co-founder Gross, FDA approval is expected by early 2006, and the device will enter the markeplace.
"We already have CE approval for Europe, but we want to launch the device first in the US. We'll soon be going to an IPO as well," Gross told ISRAEL21c.
The IMT, comprised of ultra-precision quartz glass micro-optics, is designed to be a permanent solution for moderate to profound vision loss due to AMD. Smaller than a pea, the telescope 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.
"At the end of the day, you need to see the full picture," explained Aharoni regarding the one-eye implant. "Even with normal eyes, the focus isn't on the central object first, initially it's on the periphery. It's just like the way we normally look at things. First you look at the bus coming down the street, then you focus in on the number."
It was a chance encounter with a strong focus that first brought Gross and Lipshitz together in 1995 resulting in the telescope's invention.
"I first met Isaac after my son was stung by a bee in his eye. We had to look for a good doctor to operate because it was getting infected. I was referred to him, and he asked me what I did. I told him I developed medical devices, and he said, 'great, there's a problem with AMD - there's no solution. Let's invent one together,'" said Gross.
A serial entrepreneur, Gross has founded 17 other medical device companies, but still serves as consultant to Visioncare.
"There is no cure for AMD. Photo dynamic therapy slows down the deterioration, but until now, there's been nothing to improve the vision. Our telescope doesn't cure AMD either, but we improve the vision. A person can go from almost legally blind to reading fine print," he said.
In the trials, the telescope prosthetic device was implanted in one eye of patients (average aged 76) with moderate to profound visual impairment (BCVA 20/80 - 20/800) in both eyes due to disciform scars (end-stage wet-AMD) or geographic atrophy (advanced dry AMD).
Retina specialists raved about the results.
"This first-of-kind technology is an exciting development for both ophthalmologists and our patients," said Dr. Henry L. Hudson of Retina Centers in Tucson, Arizona. "If approved for use, we would finally have an option for permanent improved central vision and independence for individuals with AMD who have difficulty with their everyday activities and hobbies, or who may feel isolated from society due to their vision."
Hudson presented the safety and efficacy results at the 109th Annual Meeting of the American Academy of Ophthalmology (AAO) and the AAO Retina Subspecialty Day meeting in Chicago.
"Despite the recent advances in the treatment of AMD, there remain a large number of patients who progress to severe vision loss each year," added Dr. Paul Sternberg, M.D., the Chairman of the Vanderbilt Eye Institute, who presented one-year data at the Retina Subspecialty Day meeting. "These patients can experience considerable improvement in visual function and quality of life from this novel device."
As was found in the earlier Phase I study, the device was well tolerated in the eye. Only 11 patients received a standard intraocular lens due to an aborted surgical procedure.
With such impressive results, VisionCare is preparing to make a big splash in the US. In preparation, the company moved its corporate to Saratoga, California but it still maintains f its research facilities in the Tel Aviv suburb of Yehud.
Next month, VisionCare will be one of the featured Israeli companies at the Israel Venture Association's Israel High Tech VC Conference in Santa Clara, California. According to Gross, it was Israeli venture capital that helped the company out of rough times during its development phase.
"We've gone through many designs and stages over 10 years. VC fund Pitango invested in us, and brought in an American CEO - Alan Hill - who has brought the company to a new level," said Gross.
Hill will be speaking at the conference on a Life Science panel in which industry experts will present the future outlook, latest trends, and investment opportunities that are developing in the Life Science field. He could look no further than his own company.
"Nobody has tried and succeeded in implanting a telescope in the eye," said Gross. "Only with a telescope can you have the magnification that eliminates the black spot and restores the vision. We believe that this is the ultimate and only solution for AMD."
Source URL: http://www.israel21c.org/bin/en.jsp?enDispWho=Articles%5El1131&enPage=BlankPage&enDisplay=view&enDispWhat=object&enVersion=0&enZone=Health.
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