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| |  FDA Approves Lucentis for the Treatment of Wet Age-Related Macular Degeneration Up to 40% of Patients Treated with Lucentis in Pivotal Studies Gained at Least Three Lines of Vision on the Study Eye Chart at One Year -- SOUTH SAN FRANCISCO, CA -- June 30, 2006 -- Genentech, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved Lucentis™ (ranibizumab injection) for the treatment of neovascular (wet) age-related macular degeneration (AMD). The FDA approved Lucentis after a Priority Review (six-month). Genentech will ship product today. Nearly all patients (95%) treated with Lucentis maintained their vision in the Phase III clinical trials. Vision improved by at least three lines (or 15 letters) on the study eye chart in up to 40% of these patients at one year. Lucentis is designed to inhibit the formation and leakage of new blood vessels in the back of the eye, the primary cause of central vision loss associated with this disease. "Lucentis provides new hope for patients with wet AMD because it is the first therapy to provide a benefit in vision for a significant number of patients," said Arthur D. Levinson, PhD, Genentech's chairman and chief executive officer. "We are proud that the seminal work in angiogenesis conducted at Genentech, years of clinical study, and the dedication and commitment of thousands of patients and retina specialists have all contributed to this important approval." "In my opinion, the Lucentis approval stands out as one of the most important medical developments in ophthalmology during my 25 years in the field because it has the potential to reverse vision loss associated with wet AMD," said Eugene de Juan, MD, president, American Society of Retina Specialists. "We are pleased that Lucentis has been approved by the FDA and look forward to working with Genentech to provide retina specialists in the United States with access to Lucentis for patients as quickly and smoothly as possible." The FDA approval of Lucentis is based on data from two large phase 3 clinical trials (MARINA and ANCHOR). In these studies: Nearly all patients (approximately 95%) treated with Lucentis (0.5 mg) maintained (defined as the loss of less than 15 letters in visual acuity) and up to 40% improved (defined as the gain of 15 letters or more in visual acuity) vision at one year, as measured on the Early Treatment of Diabetic Retinopathy (ETDRS) eye chart. On average, patients treated with Lucentis in the MARINA study experienced an improvement from baseline of 6.6 letters at two years compared to a loss of 14.9 letters in the sham group. In the ANCHOR study, patients treated with Lucentis, on average, experienced an 11.3 letter gain from baseline at one year compared to a loss of 9.5 letters in the Visudyne® photodynamic therapy (PDT) control group. Up to 40% of patients treated with Lucentis achieved vision of 20/40 or better. In addition to data from the two pivotal studies, data from the Phase I/II FOCUS and phase 3b PIER studies were included in the FDA review. 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. "Now that Lucentis is approved, we will continue to work with the retina community to evaluate how patients may be able to benefit from less frequent dosing, as emerging clinical data indicate that dosing may need to be tailored to individual patient needs," said Levinson. 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. "The impact of wet AMD goes beyond vision loss and can affect a person's ability to interact with family and friends, conduct daily activities and, overall, maintain their independence," said Dr. Stephen Rose, chief research officer at the Foundation Fighting Blindness. "As an organization dedicated to research for preventions, treatments and cures for people affected by retinal degenerative diseases, we applaud the FDA's approval of Lucentis as an important advancement in the treatment of wet AMD." 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). About Lucentis About AMD 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. 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.
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