SurModics Inc (SRDX)

[bridgeofsighs]

Enrollment in Phase IIb Clinical Trial for I-vation(TM) TA (MK-0140) Suspended Pending Review of Study Design by Merck & Co., Inc.
Friday August 8, 5:50 pm ET
Clinical Data Support Tolerability Profile; Other Development Programs with Merck are Unaffected

EDEN PRAIRIE, Minn.--(BUSINESS WIRE)--SurModics, Inc. (Nasdaq: SRDX - News), a leading provider of surface modification and drug delivery technologies to the healthcare industry, announced today that Merck & Co., Inc. has informed the company that, in light of results reported in a recently published study comparing laser treatment and intravitreal injections of triamcinolone acetonide (TA) in patients with diabetic macular edema (DME), Merck is reevaluating the design of its Phase IIb clinical trial for I-vation™ 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.


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 intravitreal injections of TA. This recently published report does not discuss I-vation TA, nor did the study evaluate 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 CEO 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.”

Additionally, SurModics remains committed to its ongoing development programs with multiple other customers pursuing the development of products incorporating SurModics’ sustained delivery technologies, including the I-vation platform, for the treatment of diseases of the eye.