This article is more than 5 years old. Information may no longer be current.

FDA expands approval of implant telescope to those age 65 and older

Add topic to email alerts

Receive an email when new articles are posted on

Please provide your email address to receive an email when new articles are posted on .

Subscribe

Added to email alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

Back to Healio

We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com.

Back to Healio

The U.S. Food and Drug Administration has approved use of VisionCare Ophthalmic Technologies’ implantable miniature telescope in a younger group of patients than was previously approved, according to a company press release.

The implant was previously approved for use in patients with end-stage age-related macular degeneration age 75 years and older. The expanded indication includes patients age 65 years and older.

The approval is based on the pivotal safety and efficacy study, IMT-002, and long-term studies IMT-002-LTM and IMT-002-LTME.

The telescope implant is Medicare eligible and currently the only FDA-approved surgical device for end-stage AMD, according to the release.

Potential adverse events include decreased vision or vision impairing corneal swelling.