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, Calif.-based company also will 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, company spokeswoman Allison Parks said. 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.
"As we age, the natural lens begins to stiffen and loses its ability to change shape which makes it more difficult to read and focus at near. As a result, millions of adults over age 50 require glasses for reading and near work. Also, millions more patients have cataracts, which further impairs their vision," said Prof. Dr. med. Gerd U. Auffarth, principal study investigator. "Current treatment options that restore both near and far vision are limited. 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."
The company is not alone in its quest to develop an alternative to cataracts. Abbott Laboratories and Bausch + Lomb have begun working on intraocular products as well. 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 percent to $276 million in the third quarter of 2013 following its purchase of OptiMedica and regulatory wins for its intraocular lenses. Bausch + Lomb secured a U.S. Food and Drug Administration (FDA) panel recommendation for its Trulign Toric eye implant in April, opening the door for full approval.
Positive study results could help PowerVision hasten 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, Parks said.
"We are deeply grateful to all of our clinical investigators for their involvement and interest in this groundbreaking study," PowerVision President/CEO Barry Cheskin said. "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."