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Implantable Miniature Telescope approved in Australia
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The Australian Department of Health Therapeutic Goods Administration has issued a Therapeutic Goods Certificate to the Implantable Miniature Telescope, VisionCare announced in a press release.
The certificate approves the device for the improvement of visual acuity in patients 55 years or older who have bilateral moderate to profound central vision impairment due to age-related macular degeneration, the release said.
“We are excited that ophthalmologists can begin to offer the Implantable Miniature Telescope to older adults in Australia whose central vision is severely impaired by end-stage macular degeneration,” Blake Michaels, president and CEO of VisionCare, said in the release. “The telescope implant is proven to improve vision and quality of life, and it is very gratifying to be able to offer our device and the comprehensive treatment program now to patients in this market.”
The Implantable Miniature Telescope is the only FDA-approved surgical device for advanced macular degeneration. It also has a CE mark in Europe and a Health Canada License, and has been approved in Israel and New Zealand.
In the U.S., it is part of the CentraSight treatment program for patients 65 years and older with end-stage AMD who meet specific eye health and vision requirements.