Drug Topics - December 10, 2007 - (Page 20)

20 DRUG TOPICS DECEMBER 10, 2007 www.drugtopics.com IN THE PIPELINE Heidi Belden, Pharm.D. Keeping an eye on the AMD market s the average age of Americans increases, so too will the incidence of age-related macular degeneration (AMD). The condition currently affects over eight million people in the United States, according to the National Eye Institute. Available treatment options are only moderately effective, can be inconvenient, and come with expensive price tags. The somewhat invasive intravitreal administration required for many therapies, along with the high cost per injection, has limited their use. As the need for effective and cost-efficient therapies continues to rise, several companies are aiming to overcome these barriers with new products in development. A noninvasive treatment inhibits endothelial nicotinic acetylcholine (nACh) receptors and has been shown to decrease angiogenesis and vascular permeability. Currently, ATG3 is in a phase II study designed to assess safety in patients with neovascular AMD. The company expects six-month data by the middle of 2008. Trap-Eye Regeneron Pharmaceuticals and Bayer HealthCare initiated a phase III trial in August of this year to evaluate VEGF Trap-Eye, a fully human soluble vascular endothelial growth factor (VEGF) receptor fusion protein that binds to all forms of VEGF-A, along with placental growth factor, for the treatment of wet AMD. The antiangiogenic agent will be stacked up against ranibizumab in a comparative trial involving approximately 1,200 patients. The study, VIEW1, will compare VEGF Trap-Eye at doses of 0.5 mg and 2 mg at four- and eight-week dosing intervals with 0.5 mg ranibizumab every four weeks. Results of an earlier phase II trial showed VEGF TrapEye met its primary endpoint of a statistically significant reduction in retinal thickness after 12 weeks of treatment. Regeneron received a $20 million milestone payment from partner Bayer HealthCare upon dosing of the first patient in the phase III study. Ease of administration Currently available AMD therapies, such as ranibizumab (Lucentis, Genentech) or the off-label use of Genentech’s bevacizumab (Avastin), require monthly intravitreal injections. Several companies are attempting to overcome the tedious process by developing AMD therapies that can be administered with the ease of eyedrops. Othera Pharmaceuticals is currently evaluating the use of OT-551 for the treatment of geographic atrophy, an advanced form of dry AMD. The molecule acts to down-regulate the disease-induced overexpression of nuclear factor kappa B, AMD is a degenerative an important part of inflammatory disease of the macula; the macula is the part of disease. In preclinical trials, the treatthe retina responsible for ment demonstrated anti-oxidative, anticentral vision. AMD is the leading cause of vision loss angiogenic, and anti-inflammatory activin people over age 65. ity. Now in phase II, OT-551 is being tested in the OMEGA (OT-551 Multicenter Evaluation of Geographic Atrophy) trial, with a planned two-year study of 198 patients at 20 retinal centers in the United States. Othera is performing another phase II study of OT-551 in conjunction with the National Eye Institute to determine the drug’s impact on disease progression in patients with bilateral geographic atrophy. In an upcoming phase II trial in 2008, Othera plans to evaluate OT-551 for wet AMD as an adjunctive therapy to ranibizumab, in an effort to reduce the frequency of ranibizumab injections required and achieve equal or improved outcomes. Also being investigated as an ophthalmic solution to treat AMD is ATG3 from CoMentis. This topical and Traditional and novel approaches Because of the retina’s susceptibility to oxidative damage, many believe that supplementation with antioxidants could have a major impact on progression of the disease. In fact, results of the age-related eye disease study (AREDS) showed that antioxidants are useful for the prevention and progression of AMD. Patients receiving vitamins C and E, zinc, and beta-carotene had a 28% reduction in the risk of progression to advanced AMD compared with placebo. AREDS-2 now seeks to assess the effects of lutein, zeaxanthin, and long-chain omega-3 fatty acids on the progression to advanced AMD. Enrollment in this study is expected to conclude by December 2007. GenVec Inc. seeks a novel solution to AMD. This company is in phase I with AdPEDF, a therapy that utilizes an adenovector DNA carrier to deliver the human pigment epithelium-derived factor (PEDF) gene. AdPEDF inhibits abnormal blood vessel growth and protects the photoreceptors which can be damaged by leaky blood vessels. DT Photo courtesy of the San Antonio Low Vision Club http://www.drugtopics.com

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Drug Topics - December 10, 2007 Latebreakers Latebreakers in Depth Letters Health-System Edition - Cover Story Clinical Practice Professional Practice Special Report Technology Community Practice Unraveling Medicare 150 Years of American Pharmacy Rx Care In the Pipeline Cover Story: Fair or foul? Self-Care Chains and Business Government and Law Continuing Education: Natural Medicines for Bone Health New Products Advertisers Index Classified Viewpoint

Drug Topics - December 10, 2007

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