* Lucentis vision improvement sustained through 24 months
* Diabetic eye disease less likely to progress on Lucentis
* More than half Lucentis patients achieve 20/40 vision
By Bill Berkrot
NEW YORK, June 28 Diabetic patients with a
vision-robbing eye condition who were treated with Roche's
ROG.VX Lucentis had significant and sustained vision
improvement compared with those who received a placebo,
according to data from a pair of pivotal clinical trials.
In addition, more than half of the patients with diabetic
macular edema (DME) who received monthly Lucentis injections in
the two-year studies improved to at least 20/40 vision, which
would enable them to receive a driver's license in most U.S.
states -- a result the lead investigator called "amazing."
"This is a real game changer. This can give you a rapid
prolonged improvement of vision and it's sustained for at least
two years," Dr. David Boyer, who presented the data on Tuesday
at the American Diabetes Association (ADA) meeting in San
Diego, said in a telephone interview.
"Within a week of treatment, Lucentis showed a reduction in
thickness (of the edema) and improvement in vision," added
Boyer, who practices at the Retina-Vitreous Associates Medical
Group in Los Angeles.
DME is currently treated by laser, which stops blood vessel
leakage and can slow vision loss but rarely leads to vision
improvement, researchers said.
Roche's Genentech unit, which developed the drug, plans to
apply for U.S. approval to treat the diabetic eye condition
later this year, which could significantly boost sales.
Lucentis is already approved to treat wet age-related
macular degeneration -- the leading cause of blindness among
the elderly. DME is a leading cause of vision loss among people
of working age.
Lucentis, a biotech drug known chemically as ranibizumab,
met the primary goal of the two Phase III trials at both tested
doses by helping significantly more patients achieve vision
improvement of at least 15 letters, or three lines, on an eye
chart than those who received sham injections.
In the 382-patient trial called Ride, 45.7 percent of those
who received 0.5 milligrams of Lucentis and 33.6 percent who
got 0.3mg Lucentis experienced vision improvement of at least
15 letters versus 12.3 percent in the placebo group.
In the 377-patient Rise trial, 39.2 percent who got the
higher Lucentis dose and 44.8 percent who got the lower dose
hit the primary vision improvement goal compared with 18.1
percent in the placebo group.
"This is a major paradigm shift. You're going to see over a
period of time more and more people using this," Boyer said.
All patients in the two trials had vision problems related
to their diabetes, researchers said.
DME is a swelling of the retina that occurs in diabetics
who suffer from retinopathy -- the most common diabetic eye
disease that involves damaged blood vessels leaking fluid into
the retina. It causes blurred vision and severe vision loss.
About 75,000 new cases of DME are estimated to develop
among Americans each year, according to the ADA.
Lucentis patients in the studies were far less likely to
see their disease progress to a more advanced form of
retinopathy, the data showed.
Fifteen percent of those in the placebo group in one study
and 11.5 percent in the other had significant disease
progression. The rates for Lucentis were 5.6 percent and 3.9
percent at the higher 0.5mg dose and 1.6 percent and 3.2
percent at the 0.3mg dose.
Boyer said Lucentis safety in the trials was consistent
with what has been reported in previous studies, adding that
"there was no real safety danger signals between the sham and
the Lucentis groups."
(Reporting by Bill Berkrot, editing by Dave Zimmerman)