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

Data From Lucentis Pivotal Phase III Studies in Wet Age-Related Macular Degeneration in New England Journal of Medicine Mean change in visual acuity over time for the Phase III MARINA ("Study 1") and the Phase III ANCHOR ("Study 2") studies of Lucentis(TM) (ranibizumab injection). Up to 40% of Patients Treated With Lucentis Improved Vision by Three Lines or More on the Study Eye Chart First Study in Wet AMD to Show Vision Improvements Maintained at Two Years SOUTH SAN FRANCISCO, CA -- October 5, 2006 -- Genentech, Inc. announced today the publication of data from the two randomized, controlled pivotal phase 3 clinical trials of Lucentis(TM) (ranibizumab injection) in the New England Journal of Medicine. The published findings include two-year efficacy and safety data from the MARINA trial and one-year efficacy and safety data from the ongoing ANCHOR trial. Based on these studies, Lucentis was granted U.S. Food and Drug Administration (FDA) approval on June 30, 2006 for the treatment of patients with the neovascular (wet) form of age-related macular degeneration (AMD), a leading cause of blindness in people over 55. The MARINA and ANCHOR clinical trials met the primary efficacy endpoint of maintaining vision (defined as a loss of less than 15 letters in visual acuity) at one year in patients with wet AMD. In these studies, nearly all patients (approximately 95%) treated with Lucentis maintained or improved vision at one year compared with 62% of patients in the MARINA control group and 64% of patients in the ANCHOR control group. Importantly, up to 40% of patients experienced an improvement in vision of three lines (15 letters) or more on the study eye chart compared with 5% and 6% of patients in the MARINA and ANCHOR control groups, respectively. The improvement in visual acuity endpoints among patients treated with Lucentis in the MARINA study was maintained at year two, while patients in the control group continued to decline. "The results of these Lucentis studies have changed the way we approach the treatment of wet AMD by demonstrating, for the first time, improvements in vision in more than one-third of patients treated," said David Brown, M.D., lead author for the ANCHOR study and retina specialist at Vitreoretinal Consultants, The Methodist Hospital in Houston, Texas. "What makes this publication particularly significant is that the visual acuity benefits after one year of treatment in the MARINA study were maintained through two years and associated with anatomic improvements consistent with the changes in visual acuity observed," said Philip J. Rosenfeld, MD, PhD, professor of ophthalmology, Bascom Palmer Eye Institute in Miami and lead author for the MARINA study. "In this study, Lucentis had a favorable safety profile and did not appear to put patients at an additional risk for systemic adverse events and the ocular adverse event rates were similar to what we would expect among people in this age group who receive an injection in the eye." Patients treated with Lucentis in these studies, on average, experienced an improvement over the control groups of three lines or more on the study eye chart. In both studies, up to 40% of patients treated with Lucentis achieved vision of 20/40 or better at one year compared with 11% of patients in the MARINA control group and 3% of patients in the ANCHOR control group. At two years, 42% of patients treated with Lucentis in the MARINA study achieved vision of 20/40 or better compared with 6% of patients in the control group. Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart, the standard method of quantifying visual acuity. "The publication of these two studies represents nearly a decade of rigorous clinical study of Lucentis that has led to a new era in the treatment of wet AMD," said Hal Barron, M.D., Genentech senior vice president, Development and chief medical officer. "We have already begun to expand on the findings of these studies to better understand optimal treatment regimens for patients with wet AMD, as well as explore the potential for Lucentis to meet other unmet medical needs in ophthalmology." Lucentis was specifically developed for intraocular use in the eye to treat the underlying cause of wet AMD by targeting the molecular pathway that controls the formation of new blood vessels. Lucentis is designed to bind and inhibit VEGF-A, a protein that is believed to play a critical role in angiogenesis (the formation of new blood vessels). Lucentis 0.5 mg is recommended for intravitreal injection once a month. If monthly injections are not feasible, treatments can be reduced to one injection every three months after the first four monthly injections. Compared to continued monthly dosing, dosing every three months will lead to an approximate five-letter (one-line) loss of visual acuity benefit, on average, over the following nine months. Patients should be evaluated regularly. About the Pivotal Studies MARINA (Minimally classic/occult trial of the Anti-VEGF antibody Ranibizumab In the treatment of Neovascular AMD) was a phase 3 randomized, multi-center, double-masked, sham-controlled study of 716 patients in the United States with minimally classic or occult wet AMD who were randomized 1:1:1 to receive intravitreal Lucentis injections (0.3 mg or 0.5 mg) or a control regimen once a month for two years. The control regimen consisted of a sham injection, meaning the treating physician prepares and anesthetizes the patient's eye but does not perform an injection. ANCHOR (ANti-VEGF Antibody for the Treatment of Predominantly Classic CHORoidal Neovascularization in AMD) is a Phase III randomized, multi-center, double-masked, active-treatment controlled study comparing two different doses of Lucentis to verteporfin (Visudyne(R)) photodynamic therapy (PDT) in 423 patients with predominantly classic wet AMD in the United States, Europe and Australia. Patients were randomized 1:1:1 to receive intravitreal Lucentis injections (0.3 mg or 0.5 mg) once a month or PDT every three months for two years. Lucentis Safety Profile In clinical trials, the most common adverse reactions among patients treated with Lucentis (reported in at least 6% more patients than in the control groups in at least one study) included conjunctival hemorrhage, eye pain, vitreous floaters, increased intraocular pressure and intraocular inflammation. Although there was a low rate (less than 4%) of arterial thromboembolic events (ATEs) observed in the Lucentis clinical trials that was not statistically different between the Lucentis and control groups, there is a theoretical risk of ATEs following intravitreal use of inhibitors of VEGF. Serious adverse events related to the injection procedure occurred in less than 0.1% of intravitreal injections, including endophthalmitis, retinal detachments and traumatic cataracts. Other serious ocular adverse events observed among Lucentis-treated patients (that occurred in less than 2% of patients) included intraocular inflammation and increased intraocular pressure. Lucentis is contraindicated in patients with hypersensitivity and ocular or periocular infections. About Lucentis Lucentis(TM) (ranibizumab injection) (0.5 mg) is approved for the treatment of patients with neovascular (wet) AMD. Lucentis is a recombinant humanized IgG1 kappa isotype therapeutic antibody fragment developed for intraocular use. Lucentis binds to and inhibits the biologic activity of human vascular endothelial growth factor A (VEGF-A), a protein that is believed to play a critical role in angiogenesis (the formation of new blood vessels). VEGF-A has been shown to lead to wet AMD disease progression and central vision loss. Lucentis was developed by Genentech and the Novartis Ophthalmics Business Unit for diseases or disorders of the eye. Genentech retains commercial rights in the United States and Novartis has exclusive commercial rights for the rest of the world. For Lucentis prescribing information, please call 1-866-Lucentis or visit http://www.lucentis.com. About AMD AMD is a major cause of painless central vision loss and is a leading cause of blindness in people over 55. The National Eye Institute estimates that there are 1.7 million people with the advanced form of AMD in the United States alone and that this prevalence will grow to 2.95 million by 2020. AMD occurs in two forms: dry and wet. The dry form is associated with atrophic cell death of the central retina or macula, which is required for fine vision used for activities such as reading, driving or recognizing faces. The wet form is caused by growth of abnormal blood vessels, also known as choroidal neovascularization (CNV) or ocular angiogenesis, under the macula. These vessels leak fluid and blood and cause scar tissue that destroys the central retina. This process results in a deterioration of sight over a period of months to years. About Angiogenesis Genentech is a leader in research and product development in the area of angiogenesis, the process by which new blood vessels are formed. In 1989, Napoleone Ferrara, M.D., and a team of scientists at Genentech conducted seminal work in the field, which resulted in the identification and cloning of a gene termed Vascular Endothelial Growth Factor (VEGF), now known as VEGF-A. The VEGF-A protein is believed to play a critical role in angiogenesis and serves as one of the key contributors to physiological or pathological conditions that can stimulate the formation of new blood vessels. The process of angiogenesis is normally regulated throughout development and adult life, and the uncontrolled growth of new blood vessels is an important contributor to a number of pathologic conditions, including wet AMD. SOURCE: Genentech, Inc. E-mail this page to a friend or colleague! To print, use this version