May 2010 Issues

American Society of Cataract and Refractive Surgery (ASCRS)

Summary: Traffic on the exhibit floor was sparse -- even worse than in 2009. However, the mood of exhibitors wasn't quite the doom and gloom as in 2009. ♦ LASIK procedures have not picked up, and industry reps were worried. ♦ The biggest buzz was the new generation of femtosecond lasers for cataract procedures, and the companies receiving the most femto attention were LensAR, LenSx, and OptiMedica. ♦ LensAR had a small booth on the perimeter of the conference, as it did last year, but its series of featured speakers attracted some attention. ♦ LenSx's flashy, high profile booth and femtosecond laser -- the only one with FDA 510(k) clearance for cataracts -- attracted a lot of attention. ♦ OptiMedica's booth was filled with enthusiastic doctors. ♦ A Ziemer meeting on its femtosecond LDV laser attracted a standing room only crowd, and session speakers spoke highly about their clinical practice with the machine.

World Vaccine Congress

Summary: Vaccine growth in the U.S. is flattening, and industry is focusing on pediatric vaccines, parasitic disease, the elderly, immunecompromised patients, and hospitalized infections. Most vaccine growth is expected OUS and in parasitic disease, therapeutics, and vaccines for diseases such as cancer. ♦ The buzzword is globalization, and companies are collaborating more, especially in the growth areas . India, Southeast Asia, Latin America, and Africa. ♦ Companies were extremely disappointed that the CDC did not recommend ACWY vaccines for children up to age 11. ♦ The MenB vaccine is likely to do well in the U.S. but will not be a blockbuster. ♦ Intercell plans to target its encephalitis vaccine to Asia and is excited about its patch delivery system. ♦ The District of Columbia's mandate to vaccinate 6th grade girls against HPV is not working well and is unlikely to spur other states to follow suit. ♦ Industry's response to H1N1 was successful, but more public education about vaccine safety is needed. ♦ There are few small international vaccine companies left to be acquired.

FDA Public Hearing on Expanded Access to Hepatitis Drugs -- Quick Pulse

Summary: The FDA held a public hearing on expanded access to investigational drugs to treat the hepatitis C virus (HCV) and on new criteria for clinical trials of direct-acting antiviral agents (DAAs) in patients with an unmet medical need, including those with the greatest risk of progression of liver disease and/or the lowest predicted sustained virologic response (SVR) rates. This was not an advisory committee meeting. Rather, a panel of FDA officials listened to comments from 16 speakers, from patients to pharmaceutical companies, to gather input for new HCV drug development guidance the Agency plans to issue later this year. The public record will be kept open until June 25, 2010, for people who want to submit written comments.