Phase III study: Twelve-Month comparison of 0.5 mg or 2.0 mg ranibizumab in patients with wet age-related macular degeneration (HARBOR)

Source: Ophthalmology
Area: News
Several small studies have suggested the potential of enhanced efficacy with higher 2mg dosing of ranibizumab. The HARBOR study was a 24-month, phase III, randomised, multicentre, double-masked study which evaluated the 12-month efficacy and safety of intravitreal ranibizumab 0.5 mg and 2.0 mg administered monthly and on an as-needed (PRN) basis in treatment-naïve patients (n=1,098) aged over 50 years with subfoveal neovascular age-related macular degeneration (wet AMD).
Noninferiority (NI) tests with a prespecified NI margin of 4 letters comparing the 0.5 mg PRN with the (Read more...)

BLOG: Let the sun shine down – CMS releases final reporting requirements for manufacturers and GPOs

On Feb. 1, 2013, the Centers for Medicare and Medicaid Services (CMS) issued its long-awaited final rule regarding the implementation of the physician payment sunshine provisions of the Affordable Care Act. The final rule does not create any new prohibitions on payments to physicians and teaching hospitals, but rather sets out new dates and requirements for manufacturers and other entities to collect data about their payments to physicians and other “covered recipients” and submit that information to CMS. Applicable manufacturers and group purchasing organizations (GPOs) must begin to collect this (Read more...)