Unregistered User If this is not your name, click here.
		Contact Us | Order Now | Journals | Bookstore | Register a colleague
	Select a ChannelAcneAIDS and HIVAllergy OtherAlzheimer'sAnaesthesiology OtherAngina Pectoris/MIAnxietyArthritis OtherAsthmaBack PainBacterial InfectionsBladder CancerBone Marrow TransplantationBreast CancerCardiology OtherCataractCell TransplantationCervical CancerCholesterol/Lipid disordersCirrhosisClinical PharmacologyColorectal CancerCongestive Heart FailureContact DermatitisContraceptionCOPDCystic FibrosisDental and Oral DisordersDepressionDermatology OtherDiabetesDialysisEating DisordersElbowEmergency MedicineEndocrinology OtherEpilepsyErectile DysfunctionFibromyalgiaGastro OtherGeneticsGenitourinary OtherGeriatricsGERD/GastritisGlaucomaH. Pylori/UlcerHaematology OtherHair LossHeadachesHepa/Biliary OtherHepatitisHipHRTHypertensionIBDImmunologyInfectious OtherInfertilityIntensive CareIrritable Bowel SyndromeKneeLeukemiasLiver CancerLung CancerLupusLymphomasMelanomaMenopauseMultiple Sclerosis Nephrology OtherNeurologic OtherNutritional / Metabolic OtherOb/Gyn OtherObesityOncology OtherOphth. OtherOphthalmic SurgeryOrgan TransplantationOrthopaedics OtherOsteoarthritisOsteoporosisOtitisOtorhino. OtherOvarian CancerPaediatricsPainPancreatic CancerParkinson'sPregnancyProstate CancerPsychiatry OtherPulmonary OtherRadiologyRenal CancerRenal FailureRespiratory InfectionsRheumatoid arthritisRheumatology OtherRhinitisSchizophreniaShoulderSleep ApnoeaSleep DisordersSpineStrokeSTDsSurgeryThyroid DisordersTransfusionTransplant Surgery OtherTraumaUrinary IncontinenceUrinary tract infectionsVaccinologyVascular DisordersViral Infections

SEARCH   News Bookstore Medline The Web Meetings & Congresses Complete Doctor's Guide    EXPLORE :    All News   All Webcasts   All Cases   All Meetings & Congresses   All Medical Resources New drugs / indications English Dictionary Medical Dictionary Thesaurus Warning | Privacy | Awards  Favourite Journals  Click here to choose your favourite journals  Favourite Sites  Click here to choose your favourite sites  Languages  Select languageEnglishFrançais

FDA Grants Priority Review To Visudyne For Age-Related Macular Degeneration ATLANTA, GA and VANCOUVER, BC -- August 23, 1999 -- CIBA Vision Corporation, the eye care unit of Novartis AG, and QLT PhotoTherapeutics Inc. announced today that the U.S. Food and Drug Administration (FDA) has assigned priority review status to the new drug application (NDA) for Visudyne™ (verteporfin for injection) therapy. The priority review status indicates that the FDA will act on the application within six months. CIBA Vision and QLT filed for approval of Visudyne therapy for the treatment of wet age-related macular degeneration (AMD), the leading cause of blindness in people over the age of 50 in the western world, on August 16, 1999. Wet AMD is characterized by the formation of abnormal leaky blood vessels (choroidal neovasculature) that grow across the central part of the retina, called the macula. The wet form represents an estimated 15 percetn of all AMD cases but accounts for approximately 90 percent of the severe vision loss associated with the disease. Currently available treatments are limited in efficacy and only applicable for approximately 10 percent to 20 percent of the 500,000 new cases of wet AMD that develop worldwide every year. Approval for Visudyne therapy was requested specifically for the treatment of AMD in patients with predominantly classic subfoveal choroidal neovascularization, the most aggressive cause of vision loss associated with the disease and for which Visudyne showed a dramatic benefit. The results of the pivotal Phase III trials, known as the TAP (Treatment of AMD with Photodynamic therapy) Investigation showed a statistically significant benefit at 12 months to those patients treated with Visudyne therapy compared to those administered a placebo. Results also showed that Visudyne therapy was well tolerated, with the majority of adverse events occurring in similar numbers among the treatment and placebo groups. E-mail this page to a friend or colleague! To print, use this version