September 2007 Issues

FDA Advisory Panel Unclear on Limits on EPO Use in Kidney Patients

Summary: An FDA advisory panel refused to put a target ceiling of ~11 g/dL on hemoglobin levels for ESAs in patients with chronic renal failure (CRF) either on dialysis or pre-dialysis, but many members were not opposed to a target range of 10 to 11.3 or 11.5 g/dL. ♦ The FDA will likely identify a target range and perhaps put a ceiling on hemoglobin levels in the ESA labels in the next few weeks. ♦ New labeling will also address issues with cycling and hyporesponders to ESA therapy.

European Society for Cataract and Refractive Surgery (ESCRS)

Summary: Multifocal IOL (mIOL) use for the next year is expected to be relatively flat in the U.S. but to grow slightly in Europe . ♦ Acri.Tec’s Acri.Lisa mIOL is generating a lot of interest and has the potential to challenge Alcon’s ReStor and Advanced Medical Optic’s ReZoom and Tecnis, especially since Acri.Tec’s purchase by Carl Zeiss Meditec. ♦ Interest in mix-andmatch mIOLs lenses appears to have stalled. ♦ Refractive surgery procedure volume in this year in the U.S. is expected to be flat to slightly down, with Europe flat to slightly up. ♦ PRK is taking a growing share of the refractive surgery procedures in the U.S. and in Europe , and that trend is expected to continue. ♦ WaveLight’s Allegretto excimer laser is gaining popularity in Europe , and that’s what most buyers said they plan to get. ♦ Ziemer’s LDV femtosecond laser has gotten off the ground and interest is growing, though it is still being fine-tuned.

Glitazones for Type 2 Diabetes

Summary: The two FDA-approved thiazolidinediones (TZDs) for Type 2 diabetes – GlaxoSmithKline’s Avandia (rosiglitazone) and Takeda’s Actos (pioglitazone) are effective in reducing the surrogate endpoints of blood glucose and hemoglobin, but both are associated with a substantial increase in the risk of heart failure. New data confirm earlier reports that Avandia increases cardiovascular (CV) risk and find that Actos does not increase CV risk. In fact, Actos may be cardioprotective.