Post-baseline vision data from Lundbeck's Sabril® patient registry is available for the first time today as a late-breaking poster presentation at the annual meeting of the American Epilepsy Society (AES). The data set includes 3,093 patients who enrolled in the mandatory patient registry during the two-year period between Aug. 21, 2009 and Aug. 22, 2011. Because of the risk of Sabril-induced permanent vision loss, the U.S. Food and Drug Administration (FDA) requires a Risk Evaluation and Mitigation Strategy (REMS) which includes an ongoing patient registry.
"These registry findings represent the first longitudinal data on Sabril therapy since its FDA approval, and include post-baseline vision data collected from a subset of patients who were reported as either having previously received Sabril or were Sabril naïve prior to entering the registry," said Robert C. Sergott, MD, lead author of the poster, director of neuro-ophthalmology at the Wills Eye Institute and professor of ophthalmology, neurology and neurosurgery at Thomas Jefferson University Medical College. Dr. Sergott was also one of two expert neuro-opthalmologists who are members of the Sabril registry steering committee and who independently reviewed detailed vision test findings for technical adequacy and clinical significance.
"The Sabril patient registry collects information on every U.S. patient who has received treatment with Sabril since it was approved by the FDA,"1 said John M. Pellock, MD, an author on the poster presentation and chairman of the Division of Child Neurology and professor of neurology, pediatrics and pharmacy and pharmaceutics at Virginia Commonwealth University. "We look forward to furthering our knowledge of Sabril through continued analysis of this data."
Of the total patients enrolled in the registry, 1,046 had refractory complex partial seizures (CPS) and 1,880 had infantile spasms (IS).
Sabril is indicated as adjunctive therapy for adult patients with refractory CPS who have inadequately responded to several alternative treatments and for whom the potential benefits outweigh the risk of vision loss. Sabril is not indicated as a first-line agent for complex partial seizures. Sabril is indicated as monotherapy for pediatric patients 1 month to 2 years of age with IS for whom the potential benefits outweigh the potential risk of vision loss.
This poster presentation (poster #: 3.330) will be made available at AES as part of the Lundbeck Scientific Exhibit (Room 337, Baltimore Convention Center, Sunday, Dec. 4, 8 a.m. - 11 a.m.) and as part of the AES official poster sessions (Convention Center Hall E, Level 100, 11 a.m. - 4 p.m., Monday, Dec. 5).