Merck & Co re-evaluating DME study design

Minnesota, USA-based SurModics, a provider of surface modification and drug delivery technologies to the health care industry, says it has been advised by drugs giant Merck & Co that, in light of results reported in a recently-published study comparing laser treatment and intra-vitreal injections of triamcinolone acetonide (TA) in patients with diabetic macular edema (DME), Merck is re-evaluating the design of its Phase IIb clinical trial for I-vation TA.

Pending this review, Merck is suspending enrollment of new patients in the study. The license and research collaboration agreement with Merck continues, and other ongoing development programs with the firm are unaffected, notes SurModics.

Merck's Phase IIb clinical trial is intended to evaluate the safety and efficacy of SurModics' I-vation TA in patients with DME. The suspension of the clinical trial follows the publication of a study sponsored by the National Eye Institute suggesting a benefit for laser treatment over intra-vitreal injections of TA. This recently published report does not discuss I-vation TA, nor did the study evaluate the safety or efficacy of sustained delivery systems.