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OSI's Macugen maintained or improved vision in more than 90% of patients
By Elaine Rigoli
Tampa, Fla., June 1 - OSI Pharmaceuticals, Inc. announced interim phase 2 study results showing that intravitreal injections of Macugen (pegaptanib sodium injection) resulted in better visual acuity outcomes in patients with macular edema due to central retinal vein occlusion compared with those receiving a sham injection.
More than 90% of patients maintained or improved vision (defined as a loss of less than 15 letters in visual acuity) at 30 weeks when treated with Macugen injections (0.3 mg or 1.0 mg) compared to approximately 69% of those treated in the control arm, according to a news release.
Patients treated with Macugen for 30 weeks had, on average, an improvement in visual acuity while the control group demonstrated a mean decrease in visual acuity from baseline to week 30 (7.5 letters improvement in the 0.3 mg group; 10.2 letters improvement in the 1 mg group; versus 1.9 letters loss in the sham group).
Vision gain was seen with a single injection of Macugen within six weeks of treatment, versus a loss in the control group.
The proportion of patients gaining 15 letters or more was 36% in the 0.3 mg group and 39% in the 1.0 mg group, compared to 28% in sham controls.
The phase 2 randomized, dose-ranging, double-masked, multi-center trial was conducted to determine the safety, efficacy and pharmacokinetics of Macugen in patients with recent vision loss due to macular edema associated with central retinal vein occlusion.
Final assessments will be performed at week 52, the release said.
Based in Melville, N.Y., OSI is a pharmaceutical company operating through three business teams, OSI Oncology, OSI Eyetech and OSI Prosidion.
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