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FDA approves VisionCare implant for AMD in patients over 65

The FDA has approved VisionCare Ophthalmic Technologies’ Implantable Miniature Telescope (by Dr. Isaac Lipshitz) for use in patients living with bilateral end-stage age-related macular degeneration (AMD) who are age 65 or older.

Saratoga, CA-The FDA has approved VisionCare Ophthalmic Technologies’ Implantable Miniature Telescope (by Dr. Isaac Lipshitz) for use in patients living with bilateral end-stage age-related macular degeneration (AMD) who are age 65 or older.

According to the company, the Medicare-eligible telescope implant-the only FDA approved surgical device for end-stage AMD-is the integral component of VisionCare's comprehensive treatment program (CentraSight), which helps patients follow the steps necessary for proper diagnosis, surgical evaluation, implantation, and postoperative care.

More in this issue: Ranibizumab approved by Health Canada, gains priority review for sBLA from FDA

The telescope implant improves visual acuity and quality of life for suitable patients with AMD whose sight is permanently obstructed by a blind spot in their central vision, making it difficult or impossible to see faces, read, and perform everyday activities such as watching TV, preparing meals, and self-care.

"We are pleased and excited about this important FDA decision," said Allen W. Hill, president and chief executive officer, VisionCare. "We developed the telescope implant to help older adults who've missed seeing moments in their life and lost much of their independence.  Now, younger individuals, those age 65 to 74, will also have access to this important therapy for treating end-stage AMD."

 

Nevertheless, the company stressed that the telescope implant is not a cure for end-stage AMD. As with any medical intervention, potential risks and complications exist with the telescope implant. Possible side effects include decreased vision or vision impairing corneal swelling.

 

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