Age-related macular degeneration (AMD) is a progressive retinal condition and is the leading cause of legal blindness in individuals over the age of 60 years. Progression of AMD leads to a decline in the ability to see fine details and loss of central vision in one or both eyes. As AMD worsens, patients frequently develop irreversible retinal damage, including scarring in the macula and large areas of atrophy. For patients with advanced AMD, this loss of central vision has a significant impact on their ability to perform daily activities like recognizing faces, reading, and driving. The implantable miniature telescope (IMT) is the first surgical intervention approved for patients with end-stage AMD. It was approved by the U.S. Food and Drug Administration in July 2010. This telescope implant is an intraocular visual prosthetic device, which is inserted into the lens capsule during cataract extraction. The power of this miniature telescope helps to magnify images two to three times their original size with the goal of improving the central vision in one eye of patients with moderate to profound visual impairment. The non-implanted eye continues to see with peripheral vision, while the eye with the telescope takes on detailed central vision. Patients with implanted miniature telescope also need therapy to help re-train their brain to use each eye differently.
Advanced age-related macular degeneration (AMD), neovascular AMD or geographic atrophy affects as many as 1.9 million people in the USA and is bilateral in at least 35% of these people. Several therapies, such as photodynamic therapy, laser photocoagulation, and intravitreal anti-vascular endothelial growth factor injections are commercially available for the treatment. An implantable miniature telescope prosthetic device is designed specifically for patients with end-stage AMD. The initial US approval limited the indication to patients older than 75 years of age because of concerns about potential safety risks in a younger cohort. Approvals by Canadian and European regulatory health authorities included younger age groups. However though the IMT can restore vision to some extent in patients with bilateral end-stage AMD, it cannot prevent the macula from further deterioration and is not considered a curative treatment.
To qualify for IMT procedure, potential patients must meet strict guidelines in that the patient must have irreversible end-stage AMD in both eyes, resulting from either dry or wet AMD. Also, other treatments for AMD including drug therapy no longer help, cannot have or had cataract surgery in the eye in which the telescope has to be implanted and must meet age, vision, and cornea health requirements including being at least 65 years old with visual acuity between 20/160 and 20/800.
Geographically, the market is segmented into North America, Europe, Asia-Pacific, Latin America and the Middle-East & Africa. North America holds the major share of the market for implantable miniature telescope market followed by Europe. The implantable telescope is the first medical device to be recommended by the panel for FDA approval for end-stage AMD in the U.S. and Australia and later in Europe.
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The key player in implantable miniature telescope market is VisionCare Ophthalmic Technologies, Inc. Over 260 of the company’s telescope implants have been used in clinical trials that have generated extensive long-term safety and efficacy data. The pivotal IMT002 clinical trial, conducted across 28 leading U.S. ophthalmic centers, demonstrated the majority of patients gained at least three lines of visual acuity on the study eye chart and clinically meaningful quality of life improvements on the National Eye Institute Visual Function Questionnaire. Most patients also gain improved facial recognition. Although it is not a cure for the disease, the implantable telescope has the potential to make a positive difference in the lives of people with end-stage AMD. VisionCare has initiated a patient education and support program about end-stage AMD and the implantable miniature telescope called CentraSight. Through the program, patients can see if they meet eligibility criteria and experience a simulation of what vision would be like with the implantable miniature telescope.
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