Genentech Inc. Monday said patients with age-related macular degeneration who received its experimental drug could read almost 1 1/2 lines more of a reading chart after a year compared with a vision loss among those who received placebo.
The trial involved 716 patients with the “wet” form of the eye disease, the leading cause of blindness in older adults. Industry analysts have said the drug, Lucentis, could become a blockbuster drug if it is approved by regulators.
Specifically, the average patient getting injections of the Genentech drug into the eye could read an additional 7 letters of a reading chart after a year’s treatment in the late-stage trial.
Those getting placebo injections, by contrast, lost the ability to read 10.5 letters over the same period as their conditions worsened. Each line of a reading chart consists of five letters.
In effect, the overall difference in favor of Lucentis amounted to about 17 letters. That means the average patient getting the Genentech drug was able to read about 3 1/2 more lines of a reading chart after a year than untreated patients.
Genentech has said U.S. regulators would likely require its drug to show a difference — in favor of Lucentis — of 15 letters: a goal the drug has accomplished.
The 17-letter difference was seen in patients given 0.3 milligram doses of Lucentis, as well as those getting 0.5 milligram injections.
Genentech said one-fourth of patients receiving the lower dose of Lucentis, and more than one-third of those given the higher dose, improved their vision by three lines or more. Fewer than 1 percent of untreated patients saw such impressive absolute improvement in vision.
In another finding, nearly 40 percent of Lucentis-treated patients had 20/40 vision or better after a year, compared with 11 percent of untreated patients.
Genentech said 20/40 vision is the typical visual sharpness required in many states for a driver license.
Monthly injections
The biotechnology company in May said about 95 percent of patients given monthly injections of Lucentis in the same trial maintained or improved their vision after a year — meeting the primary goal of the study. That compared with 62 percent of patients given placebos.
The wet form of macular degeneration is caused by an excess of blood vessels behind the macula, the central part of the retina, which bleed and thereby harm eye tissue. Lucentis, which is a fragment of Genentech’s already approved cancer drug Avastin, works by preventing the formation of blood vessels. Swiss drug maker Roche Holding AG, which owns a majority of Genentech, helped develop Avastin and is co-developing Lucentis
Genentech said it expects to unveil results of a second Phase III trial of Lucentis by the fourth quarter of 2005. The U.S. Food and Drug Administration typically requires two trials to establish the safety and effectiveness of important medicines.
A tiny New York drugmaker, Eyetech Pharmaceuticals Inc. sells the leading current treatment for the wet form of macular degeneration, called Macugen, in partnership with Pfizer Inc.
