Good news for patients with untreatable end-stage age-related macular degeneration. Developer of advanced visual prosthetic devices for individuals with age-related macular degeneration, VisionCare Ophthalmic Technologies, Inc., announced today about the FDA approval of their Implantable telescope for End-Stage AMD.
The investigational Implantable Miniature Telescope by Dr. Isaac Lipshitz) is designed to be a solution for moderate to profound vision loss due to advanced, end-stage forms of AMD that have no current surgical or medical treatment options.
The pie size device renders enlarged central vision images over a wide area of the retina to improve central vision, while the non-operated eye provides peripheral vision for mobility and orientation.
FDA Ophthalmic Devices Advisory Panel unanimously recommended that the FDA approve, with conditions, the premarket application for its implantable telescope for End-Stage AMD.
The implantable telescope is the first medical device to be recommended by the panel for FDA approval for End-Stage AMD, which is a leading cause of untreatable blindness in the U.S. End-Stage AMD occurs when the macula in each eye is irreversibly degenerated and no longer provides detailed central vision required for common everyday activities such as recognizing people and facial expressions, or watching television.
Source: FoxBusiness
Filed under Eye Care Products, Macular Degeneration | Tags: Common, end-stage age-related macular degeneration, eye, FDA, Forms, Implantable Miniature Telescope, Implantable telescope, Implantable telescope for End-Stage AMD | 1 Comment
Related?
What is Advance or End stage Macular Degeneration?April 3rd, 2009 Macular degeneration is a disorder of the central retina, or macula, which is responsible for detailed vision that controls important functional visual activities like recognizing faces and watching television. According to the National Eye Institute over 1.7 million Americans over age 50 suffer mild to profound vision loss from advanced AMD, which frequently culminates as End-Stage AMD (visual impairment due to untreatable advanced AMD).
STAAR Seeks FDA Approval of Visian TICL Implantable Contact Lens For Nearsightedness and Astigmatism TreatmentMay 1st, 2006 STAAR Surgical Co., product maker for minimally invasive eye surgery asked the Food and Drug Administration to approve its Visian TICL implantable contact lens to treat nearsightedness and astigmatism
STAAR made its request as a supplement to a pre-market approval application for its Myopic Visian ICL implantable contact lens to treat myopia in adults. That application was approved in December.
Allergan gets FDA approval for post-cataract surgery pain treatment AcuvailJuly 23rd, 2009 Allergan eye surgery drug gets FDA approvalIRVINE, Calif. — Allergan Inc., which makes eye-care products and Botox, said Thursday it received Food and Drug Administration approval for its post-cataract surgery eye solution Acuvail.
Alcon Gets FDA Approval for Travatan-Z Which Reduce Elevated Intraocular PressureSeptember 22nd, 2006 Alcon Inc. (ACL) received Food and Drug Administration approval for Travatan Z for the reduction of elevated intraocular pressure in patients with glaucoma and ocular hypertension. Travatan Z is a new formulation that eliminates benzalkonium chloride from Alcon's existing Travatan solution and replaces BAK with Sofzia, a robust ionic buffered preservative system that is gentle to the ocular surface, the eye-care company said.
IntraLase Gets Approval to Sell Femtosecond Laser System in TaiwanAugust 31st, 2006 IntraLase Corp. has received approval from Taiwan to sell the company's femtosecond laser in that country, the company said Tuesday.
Food and Drug Administration Panel Rejects 'Bionic Eye' for Citing SafetyJuly 15th, 2006 Food and Drug Administration panel rejects Implantable Miniature Telescope designed to be implanted in the eyes of some elderly patients by 10-3 vote. According to a new study, the device, which contains two lenses that work with the cornea to create a magnified image could enable some patients to do away with the special glasses and handheld telescopes, they now use to compensate for the loss in central vision caused by age-related macular degeneration.
Astigmatism and Cataract Patients May Benefit from a New Medicare RuleMarch 7th, 2007 People with astigmatism and cataracts may benefit from a new Medicare rule extending coverage for the new type of implantable lenses that treat both conditions. Astigmatism, one of the most common vision problems, causes blurry vision due to irregularly shaped cornea.
Hope for Age Related Macular Degeneration with LucentisDecember 31st, 2005 Genentech Inc. has applied for U.S.
April 3rd, 2009 at 2:54 pm
[...] VisionCare Ophthalmic Technologies, Inc., announced few days ago about the FDA approval of their Implantable telescope to treat End-Stage [...]