SurModics has announced that Merck & Co has decided to suspend enrollment of new patients in the Phase IIb study that is intended to evaluate the safety and efficacy of SurModics’s I-vation triamcinolone acetonide in patients with diabetic macular edema.
Merck has informed the company that, in light of results reported in a recently published study comparing laser treatment and intravitreal injections of triamcinolone acetonide in patients with diabetic macular edema (DME), it is re-evaluating the design of its Phase IIb clinical trial for I-vation triamcinolone acetonide (TA).
Pending this review, Merck is suspending enrollment of new patients in the Phase IIb clinical trial. The license and research collaboration agreement with Merck continues, and other ongoing development programs with Merck are unaffected.
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 intravitreal injections of TA. According to SurModics, this recently published report does not discuss I-vation TA, nor did the study evaluate the safety or efficacy of sustained drug delivery systems.
Bruce Barclay, president and CEO of SurModics, said: “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.”
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