03.19.19

VisionCare Announces Regulatory Approval of the CentraSight Treatment Program in Australia

Source: VisionCare

VisionCare announced that the Australian Department of Health Therapeutic Goods Administration has issued a Therapeutic Goods Certificate to the Implantable Miniature Telescope (by Dr. Isaac Lipshitz), approving it for the improvement of visual acuity in patients who are 55 years and older with bilateral moderate to profound central vision impairment due to age-related macular degeneration.

In the United States, the telescope implant is part of the CentraSight treatment program, which is for people 65 years and older diagnosed with end-stage, age-related macular degeneration who meet specific eye health and vision requirements, and for whom common treatments such as glasses, vitamins, drugs, or cataract surgery will not lead to vision improvement. The telescope implant is contraindicated in patients with previous intraocular or corneal surgery of any kind in the operative eye, including cataract surgery.

“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 a company news 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.”

CentraSight Available Around the World

The telescope implant is the only FDA-approved surgical device for advanced macular degeneration and is Medicare eligible. Beyond the United States, it also holds the CE Mark, Health Canada Licence and is approved for use in, Israel, New Zealand and now, Australia. It is manufactured in an FDA registered facility.

Last month, the very first telescope implant procedure was performed in Canada by corneal surgeon, Richard Bazin, MD, FRCSC, at the Saint-Sacrement Hospital in Quebec.

VisionCare is also conducting a clinical investigation in the United States to evaluate the safety and effectiveness of exchanging a previously implanted IOL with the telescope implant. According to current U.S. labeling, the telescope implant is contraindicated in patients with previous intraocular or corneal surgery of any kind in the operative eye, including cataract surgery.

 

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