November 2009 Issues

American Society of Nephrology’s Renal Week -- Quick Pulse

Summary: An important focus of Renal Week was on the management of conditions such as anemia, hyperphosphatemia, fibrosis, and hypertension in chronic kidney disease (CKD) and end-stage renal disease (ESRD).  Overall, many of the results presented at Renal Week did not look favorable for the risk:benefit profile of erythropoiesis-stimulating agent (ESA) use in CKD patients.

American Academy of Ophthalmology (AAO)

Summary: Ophthalmologists and their patients are feeling the impact of the recession, but things don’t appear to be getting worse. ♦ LASIK surgery appears to have bottomed and is likely to remain flat for the next 6-12 months. ♦ Premium IOLs have lost a little market share overall, but within their niche, Alcon’s new ReStor 3.0 is a big improvement and is luring customers from Bausch & Lomb’s Crystalens HD, which many doctors view as worse than the old Crystalens 5.0. Abbott’s Tecnis has mostly replaced ReZoom but is a minor player. ♦ Doctors are very interested in femtosecond cataract surgery, and LenSx, LensAR, and OptiMedica are leading the way. ♦ The glaucoma device pipeline doesn’t look very promising. Generic latanoprost is expected to take huge market share. ♦ Retina surgeons are waiting for the results of the CATT head-to-head study of Avastin and Lucentis in wet AMD while investigating a number of potential new treatments for dry AMD. ♦ Autofluorescence is the hot new topic in imaging, picking up things that current OCT does not. ♦ Financial issues – especially Medicare reimbursement and healthcare reform – are a big concern, but ophthalmology appears in a better position than some other medical specialties.

FDA Advisory Panel Votes Overwhelmingly to Approve Acorda’s Fampridine-Sr for Multiple Sclerosis -- Quick Pulse

Summary: The FDA’s Peripheral and Central Nervous System Drugs Advisory Committee voted overwhelmingly (12 to 1) to recommend approval of Acorda Therapeutics’ Ampriva (fampridine-SR), a 10 mg 4-aminopyridine (4-AP) sustained-release (SR) tablet for the symptomatic improvement of walking ability in patients with multiple sclerosis (MS). It would be a new indication, never before granted by the FDA, as currently-approved MS drugs are indicated to decrease relapse rate and, in some cases, to prevent the accumulation of disability.