Inspire drops retinal disease drug development due to lack of efficacy

By Angela McDaniels

Seattle, Jan. 20 - Inspire Pharmaceuticals Inc. said it has discontinued two phase 2 pilot clinical trials of denufosol tetrasodium intravitreal injection (INS37217 Ophthalmic) in patients with macular edema and has no plans to conduct any further studies of denufosol for the treatment of retinal disease.

"During our recent portfolio review process, we prioritized our research and development programs and decided to discontinue the retinal program so that we can apply our resources to programs with higher potential value," president and chief executive officer Christy L. Shaffer said in a company news release.

"Our utilization of small pilot trials to explore potential new indications enables us to gather information quickly and make prudent development decisions efficiently, thereby minimizing the time and expense of drug development."

The two pilot trials of denufosol began in the second and third quarters of 2005.

Data from the first trial was reviewed following the treatment and evaluation of 12 patients with persistent macular edema associated with uveitis. The data did not demonstrate improvement in either reduction of retinal thickness or improvement in visual acuity, the company said.

The second trial, which had not yet enrolled any patients, was targeted to enroll 15 patients with persistent macular edema following cataract surgery.

Inspire has stopped enrollment in both trials but said it will continue to follow the treated patients for a period of one year, as specified in the safety protocol.

Inspire is a biopharmaceutical company based in Durham, N.C., that discovers, develops and commercializes prescription pharmaceutical products in disease areas with significant commercial potential and unmet medical needs.

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