08.11.08
Merck is reevaluating the design of its Phase IIb trial for I-vation TA that it's conducting with SurModics, Inc. and therefore suspending enrollment of new patients in the trial. The decision follows recent study results comparing laser treatment and intravitreal injections of triamcinolone acetonide (TA) in patients with diabetic macular edema (DME).
Merck’s Phase IIb trial is intended to evaluate the safety and efficacy of SurModics’ I-vation TA in patients with DME. The trial suspension follows the publication of a study sponsored by the National Eye Institute suggesting a benefit for laser treatment over intravitreal injections of TA. This report does not discuss I-vation TA or the safety or efficacy of sustained drug delivery systems.
"The decision to suspend enrollment in this clinical trial is based solely on the results reported in a recently published study comparing laser treatment and intravitreal injections of TA," said Bruce Barclay, president and chief executive officer of SurModics. "We believe the data from the Phase I and Phase IIb clinical trials generated to date provide support for the tolerability profile of I-vation TA, and more generally, that of the I-vation sustained delivery platform.”
Merck’s Phase IIb trial is intended to evaluate the safety and efficacy of SurModics’ I-vation TA in patients with DME. The trial suspension follows the publication of a study sponsored by the National Eye Institute suggesting a benefit for laser treatment over intravitreal injections of TA. This report does not discuss I-vation TA or the safety or efficacy of sustained drug delivery systems.
"The decision to suspend enrollment in this clinical trial is based solely on the results reported in a recently published study comparing laser treatment and intravitreal injections of TA," said Bruce Barclay, president and chief executive officer of SurModics. "We believe the data from the Phase I and Phase IIb clinical trials generated to date provide support for the tolerability profile of I-vation TA, and more generally, that of the I-vation sustained delivery platform.”