Age-related macular degeneration device wins FDA approval in patients aged 65+

Smaller than a pea, the telescope implant uses wide-angle micro-optics to improve vision for patients with end-stage AMD.--Courtesy of VisionCare Ophthalmic Tech

The FDA approved VisionCare Ophthalmic Technologies' Implantable Miniature Telescope in patients with bilateral end-stage age-related macular degeneration aged 65 or older, the company announced today.

"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," said company CEO Allen Hill in a statement.

The tiny telescope is implanted in one eye in an outpatient surgical procedure and renders enlarged central vision images over a wide area of the retina to improve central vision. The device is the only treatment for end-stage AMD; even cataract surgery won't fix the condition VisionCare, says. The Telescope is the centerpiece of VisionCare's four-step CentraSight program to assist patients with the condition.

The device was first approved by the FDA in 2010. In a clinical study, 90 patients had at least a two-line gain in visual acuity, and 75% of patients' vision improved to moderately impaired.

Also, the company last year, disclosed that the Centers for Medicare and Medicaid Services proposed assigning the implant to a new ambulatory implant procedure code, where the mean cost would be calculated using available claims data. That would mark a change from traditional reimbursement procedures.

And in 2012 the company announced the closing of Series E financing round, after the original Series E yielded $31 million in the previous year.

- read the release

Suggested Articles

The FDA has approved its first contact lens designed to effectively slow the progression of nearsightedness in children, starting in ages 8 to 12.

Novartis tapped Biofourmis to develop tracking programs for heart failure patients, as the latter acquired Biovotion, makers of clinical wearables.

Janssen is planning its first completely virtual clinical trial, using personal smartphones and wearable devices with no in-person site visits.