On Tuesday, the FDA approved Saratoga, CA-based VisionCare Ophthalmic Technologies' implantable miniature telescope for patients with age-related macular degeneration. VisionCare's first-of-kind telescope implant is integral to a new patient care program, CentraSight, for treating patients with end-stage macular degeneration, the company says 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 non-operated eye provides peripheral vision for mobility and orientation. The two models provide 2.2 or 2.7 times magnification. In a clinical study, 90 patients had at least a two-line gain in visual acuity, and 75 percent of patients' vision improved to moderately impaired.
"The clinical results from the pivotal FDA trial have proven we can place this tiny telescope prosthesis inside the eye to help patients see better and, for some, even to levels at which they can recognize people and facial expressions that they could not before," Kathryn Colby, ophthalmic surgeon at Massachusetts Eye and Ear Infirmary in Boston and an Assistant Professor of Ophthalmology at Harvard Medical School, says in a company statement.
VisionCare will conduct a post-approval study to monitor patient outcomes. Potential candidates for the implant must be more than 75 years of age with stable severe to profound vision impairment.
VisionCare has raised $46 million to date, including $20 million in the last round that was led by Boston Scientific Inc. (NYSE: BSX). Other investors include Israel Infinity Venture Capital, Pitango Venture Capital, JP Morgan, Onset Ventures, Three Arch Partners and Canada-Israel Opportunity Fund, Globes notes.
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