Inspire Pharmaceuticals Inc. has discontinued two phase 2 pilot clinical trials of denufosol tetrasodium intravitreal injection (INS37217 Ophthalmic) in patients with macular oedema and has no plans to conduct any further studies of denufosol for the treatment of retinal disease.
The two pilot trials of denufosol were initiated in the second and third quarters of 2005. The first trial was targeted to enrol 15 patients with persistent macular oedema associated with uveitis. Data from this trial was reviewed following the treatment and evaluation of 12 patients. There were no significant safety or tolerability issues identified in the trial. The data did not demonstrate improvement in either reduction of retinal thickness or improvement in visual acuity. The second trial was targeted to enrol 15 patients with persistent macular oedema following cataract surgery. No patients had yet enrolled in the second trial. Inspire has stopped enrolment in both trials, but will continue to follow the treated patients for safety for a period of one year, as specified in the protocol, claims a company release.
Christy L. Shaffer, president and CEO of Inspire, commented, "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. 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."
Inspire is a biopharmaceutical company dedicated to discovering, developing and commercialising prescription pharmaceutical products in disease areas with significant commercial potential and unmet medical needs.