|PowerVision's fluid intraocular lens--Courtesy of PowerVision|
It's a crowded market for ophthalmological devices, and PowerVision wants to keep a leg up on the competition: As part of a new multicenter clinical study, the company implanted its innovative fluid-based intraocular lens into 10 patients.
The study is intended to evaluate the performance of PowerVision's FluidVision lens in cataract patients and will take place in various locations in Germany and South Africa. Participants who received implants are enrolled for testing at three eye centers in South Africa. The Belmont, CA-based company will also begin enrolling patients at four test sites in Germany later this year. Study enrollment will be capped at 115 participants, the company said in a statement.
PowerVision's FluidVision lens provides an alternative to traditional implants, which are more rigid and less comprehensive in scope, a company spokesman told FierceMedicalDevices. Patients with regular implants often still wear reading glasses, and cataracts can further complicate vision. PowerVision's lens contains fluid that moves in response to muscle movement, imitating natural processes that occur in the eye. The fluid becomes thicker for near distances and thinner when a patient needs to see far away.
"Results from an earlier pilot study of the FluidVision lens are quite encouraging, and we believe patients will benefit significantly from this lens which has the potential to restore the eye's ability to focus clearly on objects near, far and in between," said Dr. Gerd Auffarth, the study's principal researcher.
The company is not alone in its quest to develop an alternative to cataracts: Big names like Abbott Laboratories ($ABT) and Bausch + Lomb have already begun work on intraocular products. In 2013, Abbott closed a deal for OptiMedica to gain access to the company's laser cataract surgery system, hoping to cash in on a growing market. The company's medical optics unit increased 7.3% to $276 million in the third quarter of 2013 following its purchase of OptiMedica and regulatory wins for its intraocular lenses. Bausch + Lomb secured an FDA panel recommendation for its Trulign Toric eye implant in April, opening the door for full approval.
Positive study results could be just what PowerVision needs to accelerate approval for its own intraocular device. The company plans on securing a CE mark for its FluidVision lens in 2015, and FDA approval will likely come a few years later, CEO Barry Cheskin said through a spokeswoman.
"We are deeply grateful to all of our clinical investigators for their involvement and interest in this groundbreaking study. … Many millions of people around the world are impacted by cataracts and presbyopia and we believe there is a significant unmet need for more effective treatments of these clinical conditions," he said in an emailed statement.
- read the release
Editor's Note: An earlier version of this story wrongly attributed some comments to a spokeswoman for Powervision. The comments originated with the company's CEO, Barry Cheskin.