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news.Inspire Pharmaceuticals has discontinued two phase II pilot clinical trials of its investigational product denufosol injection in patients with macular edema, and has no plans to conduct any further studies of the drug for the treatment of retinal disease.
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The two pilot trials of denufosol were discontinued after the drug failed to produce improvement in either reduction of retinal thickness or improvement in visual acuity.
Both trials were initiated in the second and third quarters of 2005. The first trial was targeted to enroll 15 patients with persistent macular edema associated with uveitis, and the decision to discontinue development of the drug in retinal disease was made after 12 patients were treated in this study.
The second trial was targeted to enroll 15 patients with persistent macular edema following cataract surgery, but no patients were enrolled in this study.
Inspire says that it will continue to follow the treated patients for safety for a period of one year, in accordance with the trial protocol.
“During our recent portfolio review process, we prioritized our R&D programs and decided to discontinue the retinal program so that we can apply our resources to programs with higher potential value,” commented Dr Christy Shaffer, president and CEO of Inspire.