BELMONT, Calif., March, 2014 — PowerVision, Inc., a medical device company developing the world’s first fluid-based accommodating intraocular lens, today announced that the first 10 patients have received lens implants in its multi-center clinical study assessing the performance of the lens in cataract patients. These patients received their implants at the three eye centers in South Africa that are participating in the study; four sites in Germany are also participating in the study and will begin enrolling patients later in 2014. The planned enrollment in this study is 115 participants undergoing cataract surgery. This study will form the basis for PowerVision’s CE marking of the FluidVision lens in the European Union, which is expected to occur sometime next year.
“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 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.”
Accommodation refers to the eye’s ability to dynamically adjust focus to see up close and at a distance. The FluidVision lens, PowerVision’s novel fluid-controlled accommodating intraocular lens, contains fluid inside the lens that moves in response to the natural muscle forces in the eye. The FluidVision lens provides True Accommodation™ by mimicking the eye’s natural accommodative process, becoming thicker when the patient needs to see up close or thinner when he or she needs to see far away.
“We are deeply grateful to all of our clinical investigators for their involvement and interest in this groundbreaking study. We expect to complete patient enrollment this year and to receive the CE Mark sometime in 2015,” said PowerVision’s President & CEO, Barry Cheskin. “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.”
Participating South African sites in the current study are:
John Hill Eye Laser Centre in Claremont, Cape Town under direction of Principal Investigator, John Hill, M.D.
Visiomed Laser Centre in Northcliff, Johannesburg under direction of Principal Investigator, Michael A Muller, M.B. ChB
Optimed Eye and Laser Centre in Queenswood, Pretoria under direction of Principal Investigators Frik J Potgieter, M.B. Ch.B and Paul Roux, M.D.
Participating German sites are:
Department of Ophthalmology Ruprecht-Karls University Heidelberg, Heidelberg, Baden-Wurttemberg, under the direction of Principal Investigator Gerd F. Auffarth, M.D.
Charlottenklinik fuer Augenheilkunde, Stuttgart, Baden-Wurttemberg, under the direction of Principal Investigator Gangolf Sauder, M.D.
Center for Vision Science Ruhr University Eye Hospital, Bochum, North Rhine-Westphalia, under the direction of Principal Investigator Burkhard Dick, M.D.
Augentagesklinik, Berlin, under the direction of Principal Investigator Manfred Tetz, M.D.
For more information, please visit clinicaltrials.gov, study identifier NCT02049567.
About Presbyopia and Cataracts
Presbyopia is a vision condition in which the crystalline lens of the eye loses its flexibility, which makes it difficult to focus on close objects. Presbyopia may seem to occur suddenly, but the actual loss of flexibility takes place over a number of years. Presbyopia usually becomes noticeable in the early to mid-40s. Presbyopia is a natural part of the aging process of the eye. It is not a disease, and it cannot be prevented. The potential market for presbyopia treatments exceeds $5 billion annually in the U.S alone.
A cataract is a cloudy or opaque area in the normally clear lens of the eye. Depending upon its size and location, it can interfere with normal vision. Most cataracts develop in people over age 55, but they occasionally occur in infants and young children. The treatment of cataracts is based on the level of visual impairment they cause. When a cataract progresses to the point that it affects a person’s ability to do normal everyday tasks, surgery may be needed. Cataract surgery involves removing the diseased lens and replacing it with an artificial lens. Cataracts affect millions of Americans and Medicare currently spends $3.4 billion to treat these cataracts annually.
PowerVision Inc. is a private company focused on developing a novel accommodating intraocular lens, which, it believes, will be the first to restore True Accommodation™. Its innovative FluidVision accommodating intraocular lens (IOL) aims to restore the vision of youth to older individuals affected by presbyopia and/or cataracts. PowerVision’s mission is to provide a family of fluid-based lens implants that meet the clinical and lifestyle needs caused by these conditions, and develop the most significant innovation in vision correction surgery since the introduction of the intraocular lens. The FluidVision lens is an investigational device that is not available for sale and is available for use only by the investigators participating in the multi-center clinical study.