ot-551 for wet age-related macular degeneration (wet amd)

As a topical eye drop with a unique mechanism of action, OT-551 has the potential to change the treatment paradigm for the wet form of age-related macular degeneration (wet AMD). Like geographic atrophy, wet AMD is a severe form of macular degeneration that rapidly leads to blindness. Despite recent advances in treatment options, wet AMD remains a serious unmet medical need with no patient-administered options.

The most utilized FDA-approved treatment, Lucentis®, requires injections to the eye approximately once per month over multiple years. Othera is planning to initiate a Phase 2 trial in 2008 to evaluate OT-551 as an adjunctive therapy to Lucentis® in patients with wet AMD. The goal of this trial would be to demonstrate a reduction in the frequency of Lucentis® treatments with equal or improved outcomes.

About Wet AMD

Neovascular (wet) AMD is a severe form of AMD that typically occurs after progression of dry AMD. According to the National Eye Institute, approximately one million Americans currently suffer from wet AMD. Like dry AMD, that number of affected Americans is expected to double by 2020.

Wet AMD is characterized by the sudden growth of new and abnormally fragile blood vessels around the retina. Leakage from these blood vessels can cause rapid damage and scarring to the macula. The progression of this neovascularization can be visualized and tracked using imaging technology. From initial diagnosis, patients can experience the loss of three lines of vision (e.g., changing from 20/20 to 20/40 or worse as measured on a conventional eye doctor’s letter chart) in a matter of weeks or months, requiring immediate treatment. If left untreated, wet AMD can lead to a near total loss of central vision within months or a few years.

Genentech’s Lucentis® and other newly-approved treatments are now available to address inappropriate blood vessel formation, but these new drugs are generally very expensive or invasive. Furthermore, they may fail to address the underlying damage to the retina, and often do not reverse vision loss on their own.

OT-551 in Wet AMD

OT-551 eye drops act through a mechanism distinct from that of Lucentis® and other anti-VEGF approaches, and therefore may improve outcomes when used in combination with these therapies. OT-551 has shown a synergistic anti-angiogenic effect in preclinical models of wet AMD when applied together with Lucentis® or Avastin®. This data was presented at the Angiogenesis 2007 Symposium in February 2007.

Lucentis and Avastin are registered trademarks of Genentech, Inc.