Interim PII data for Macugen versus central retinal vein occlusion:
>>Preliminary Topline Efficacy Results from Phase II Data Show Macugen(R) (pegaptanib sodium injection) Maintained or Improved Vision in over 90 Percent of Patients with Macular Edema Associated with Central Retinal Vein Occlusion (CRVO)
Thursday June 1, 7:45 am ET
Study results suggest efficacy of selective vascular endothelial growth factor (VEGF) inhibition in treating common cause of vision loss in patients with retinal vascular disease
NEW YORK--(BUSINESS WIRE)--June 1, 2006--OSI Pharmaceuticals, Inc. (NASDAQ: OSIP - News) announced today interim Phase II 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 (CRVO), compared with those receiving a sham injection. Over 90 percent 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 percent of those treated in the control arm (p less than 0.05 for both doses). 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 6 weeks of treatment, versus a loss in the control group. The proportion of patients gaining 15 letters or more was 36 percent in the 0.3 mg group and 39 percent in the 1.0 mg group, compared to 28 percent in sham controls.
More complete trial results including a summary of safety and other secondary efficacy analyses from the trial will be presented at the 24th Annual Meeting of the American Society of Retina Specialists (ASRS), September 9-13, in Cannes, France. We expect the safety results from Macugen in CRVO to be similar to the substantial safety database and experience of Macugen in neovascular AMD.
"Retinal vein occlusion, or RVO, is a common cause of marked or total loss of vision in the middle-aged and elderly population. Despite the fact that more than 130,000 new cases of RVO are reported each year, there are currently no approved pharmacological treatments to treat the condition," said Anthony P. Adamis, M.D., Chief Scientific Officer, (OSI) Eyetech. "These data are important because they suggest that through selective VEGF inhibition, Macugen may be effective at targeting the underlying pathologies that play a significant role in promoting the vision loss associated with RVO."
About the Study
This Phase II 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 CRVO.
In the study, 98 patients were randomized to receive Macugen 1 mg or 0.3 mg or sham intravitreous injection, once every six weeks for 24 weeks. Endpoints included the difference in change from baseline mean visual acuity (ETDRS VA) between sham and 0.3 mg, and between sham and 1 mg, both at 30 weeks after five treatments. Other endpoints included optical coherence tomography (OCT), fluorescein angiography (FA) and photographic assessments, as well as population pharmacokinetics. Final assessments will be performed at week 52.
About Central Retinal Vein Occlusion
Retinal vein occlusion (RVO) is an eye condition characterized by blockage of the central retinal vein or one of its branches. When the vein is blocked, blood flow backs up and causes tiny hemorrhages, areas of swelling and other pressure-related damage in portions of the retina that are located near the blocked blood vessels. This can cause minimal or substantial loss of vision, depending on the extent of this retinal damage. The risk factors for this disorder include aging, high blood pressure, diabetes, glaucoma and smoking.
Central retinal vein occlusion (CRVO) is the second leading cause of visual loss due to retinal vascular disease, and can be caused by abnormal growth of blood vessels. Most occlusions occur after age 50, with the highest rate of occurrence in individuals in their 60's and 70's.<<
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