Results from a Phase 3 study demonstrate
MACUGEN® (pegaptanib sodium) significantly improved vision in
patients with diabetic macular edema (DME), a complication of
diabetes that is a leading cause of blindness in people of
working age.(1) In the study, 37 percent of patients treated
with MACUGEN gained two lines, or 10 letters, of vision on the
ETDRS eye chart at 54 weeks, compared to 20 percent of patients
who received a sham (placebo-like) procedure which consists of
anesthesia and a simulated injection in the eye (p=0.0047). The
data were presented today at the World Ophthalmology Congress in
Berlin by Frank G. Holz, an investigator in the trial and
director of the University Eye Hospital at the University of Bonn
in Germany.
“These encouraging Phase 3 results demonstrate that MACUGEN has
the potential to improve vision in people with DME, a serious
complication of chronic diabetes,” said Marla B. Sultan, M.D.,
M.B.A., global clinical lead for MACUGEN at Pfizer. “Currently
there are no approved pharmaceutical treatments for DME, and when
untreated, about one out of four people with this condition
will develop moderate vision loss within three years,” said Dr.
Sultan. “Pfizer is pleased to be exploring MACUGEN as a
potential treatment option to address this unmet medical need.”
The phase 3 trial met its primary endpoint of the proportion of
patients gaining greater than ten letters vs sham at one year.
On average, patients treated with MACUGEN gained 5.2 letters of
vision at year one compared to 1.2 letters for patients receiving
sham (p