OSI, Pfizer start phase 4 trial of Macugen for age-related macular degeneration

New York, June 26 - OSI Pharmaceuticals, Inc. and Pfizer Inc. said they have begun a phase 4 trial of Macugen (pegaptanib sodium injection) as a maintenance therapy for patients who have received prior neovascular treatment for age-related macular degeneration and experienced improvement in macular disease.

The 54-week trial is expected to include up to 1,000 patients at 100 sites across the United States.

Neovascular age-related macular degeneration is a chronic, progressive disease that may require ongoing management, the companies said.

Nearly 70,000 patients have already been treated with Macugen, which offers proven efficacy and safety for up to two years in the treatment of neovascular age-related macular degeneration with six-week dosing.

Safety may be an important consideration when choosing a maintenance therapy, the companies noted.

"Armed with a growing number of treatment options, we should explore new regimens that may be capable of providing beneficial patient outcomes while addressing long-term safety and dosing considerations," Thomas R. Friberg, professor of ophthalmology and bioengineering at the University of Pittsburgh Medical Center and a lead investigator in the trial, said in a news release.

The trial is open label. Patients must have had at least one, but no more than three treatments for neovascular age-related macular degeneration within 30 to 120 days prior to the study leading to an improvement in macular disease. Macugen will be administered once every six weeks for 48 weeks.

Booster treatment with additional neovascular age-related macular degeneration therapy may be employed if the investigator believes macular disease has progressed.

The trial is being called Level, a name OSI and Pfizer extracted from "EvaLuation of Efficacy and safety in maintaining Visual acuity with sEquential treatment of neovascuLar AMD."

Based in Melville, N.Y., OSI develops pharmaceutical products for the treatment of cancer, eye diseases and diabetes. Pfizer is a New York-based pharmaceutical company.

© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere. For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.