Industry News — Clinical Updates
VisionCare Receives Expanded FDA Approval for Implantable Miniature Telescope to Include AMD Patients Age 65 and Older
The US Food and Drug Administration (FDA) has expanded its approval of the implantable miniature telescope from VisionCare Ophthalmic Technologies, Inc. (Saratoga, CA) to include patients 65 years of age and older living with bilateral end-stage AMD. The implant is an integral component of VisionCare's comprehensive treatment program, CentraSight, and it is the only FDA-approved surgical device for end-stage AMD. The telescope implant was previously approved by the FDA for patients 75 years of age and older and is Medicare eligible.
The implantable miniature telescope is indicated for monocular implantation to improve vision in patients with stable severe to profound vision impairment (best-corrected distance visual acuity (BCVA) 20/160 to 20/800) caused by bilateral central scotomas associated with end-stage AMD. The telescope is implanted in one eye through an outpatient surgical procedure. In the implanted eye, the device renders enlarged central vision images over a wide area of the retina to improve central vision, while the non-operated eye provides peripheral vision for mobility and orientation.
The FDA’s expansion of the implantable miniature telescope to include patients 65 and older was based on clinical data provided by the pivotal safety and efficacy study, IMT-002, and long-term studies IMT-002-LTM and IMT-002-LTME, which followed patients to 5 and 8 years, respectively.
Updated October 14, 2014