PowerVision Announces Key Six Month Data from FluidVision™ Pilot Study
Data show excellent vision restored with revolutionary accommodating intraocular lens
Results presented at the ASCRS Annual Symposium
BOSTON (April 28, 2014) – PowerVision, Inc., a medical device company developing the world’s first fluid-based accommodating intraocular lens, today announced that six-month data from the pilot study of the FluidVision™ lens confirmed the lens’ ability to restore vision at all distances. Results were presented by principal investigator Professor Paul Roux of the Optimed Eye and Laser Clinic in Pretoria, South Africa at the American Society of Cataract and Refractive Surgery (ASCRS) Annual Symposium, which concludes here today.
The FluidVision lens provides True Accommodation™ by mimicking the eye’s natural accommodative process to change shape and adjust focus the way that young, healthy eyes do. The lens is implanted using the same surgical techniques as are used with traditional intraocular lenses.
“The ability of this intraocular lens to restore accommodation is truly ground-breaking. If outcomes of the ongoing CE mark study confirm these extremely promising results, I believe that the FluidVision lens could become the new standard in cataract and presbyopia surgery,” said Professor Roux. “We believe the lens has the power to restore youthful vision to patients affected by these conditions caused by normal aging and free them from the need to ever wear glasses or contacts again. Current treatment methods only solve half the problem and many patients must still wear reading glasses or other corrective lenses to see both near and far. The FluidVision lens would eliminate that need, and could provide a much sought-after solution to millions of people.”
The pilot study included 20 patients who were candidates for cataract surgery and underwent implantation of the FluidVision lens in one eye. Initial results showed excellent distance vision, averaging better than 20/20 at six-month follow-up. Visual acuities at intermediate and near were also impressive at six months, approximately 20/25 and 20/33 respectively, when tested in one eye, and allowed patients to read without glasses. The visual outcomes provided by the lens should improve even more in patients when they have lenses implanted in both eyes. The study also confirmed the safety of the lens, with no clinical complications or adverse events reported.
“We are extremely pleased with the outcome of our pilot study and look forward to confirming these results in our ongoing CE Mark study,” said President and CEO, Barry Cheskin. “Seven sites in Germany and South Africa are enrolling patients, and nineteen patients have been implanted to date. We expect to complete patient enrollment this year and to receive the CE Mark sometime in 2015. This study will lay the groundwork for potential commercialization in the EU and further studies in the United States.”
Separate studies presented at the symposium highlighted the FluidVision lens’ unique delivery system, PowerJect, which allows physicians to easily prepare the lens for implantation and then implant it, and also demonstrated that the lens capsule is remarkably stable over time after implantation of the lens.
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.
The American Society of Cataract and Refractive Surgery is an international educational society with more than 9,000 members. Its mission is to advance the art and science of ophthalmic surgery and the knowledge and skills of ophthalmic surgeons by providing clinical and practice management education and by working with patients, government, and the medical community to promote the delivery and advancement of high-quality eye care. www.ASCRS.org.
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.
*American Optometric Association: http://www.aoa.org/patients-and-public/eye-and-vision-problems/glossary-of-eye-and-vision-conditions/presbyopia
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