|
E-mail this page to a friend!
Lucentis Improves Vision In Patients with Wet
Age-Related Macular Degeneration
Other successful treatments have focused on slowing
vision loss
Aug. 1, 2005 Lucentis (ranibizumab) has improved
vision in people with wet age-related macular degeneration (AMD), which
is a significant advance, since other drug treatments of AMD have
focused on slowing vision loss, rather than restoring sight. AMD is the
leading cause of blindness for people over the age of 60 in the United
States and Canada. The National Eye Institute estimates that there are
1.6 million people with AMD in the United States alone and that this
prevalence will grow to 2.95 million by 2020.
| |
Related Stories |
|
| |
Discovery Could Lead to Treatment of Macular
Degeneration
June 21, 2005 Scientists say they have discovered
a protein F4/80 may play a role in the regulation of the immune
response and protect delicate tissues that cannot survive the
inflammation inherent in full-blown immunity. This discovery, they
hope, can help in developing therapies for blinding eye disease, like
macular degeneration that leads to blindness in many senior citizens.
Read more...
Five Vision Topics Added to NIH Senior Health Website
June 20, 2005 - Eye diseases and conditions leading
to vision loss increase significantly with age, and the number of people
with vision loss is expected to rise as the population grows older. To
help senior citizens and baby boomers learn more about these conditions
and vision loss, the NIHSeniorHealth Web site is adding five new topics
on vision: glaucoma, cataract, age-related macular degeneration (AMD),
diabetic retinopathy, and low vision.
Read more...
Vision hope for seniors
Macugen Hits Market to Treat Age-Related Macular Degeneration
Jan. 21, 2005 - Macugen (pegaptanib sodium
injection), the recently FDA-approved treatment for neovascular
age-related macular degeneration (AMD) is now available to retinal
specialists through three distributors, according to Eyetech
Pharmaceuticls, Inc. AMD is the leading cause
of irreversible, severe loss of vision in people 50 and older.
Read more...
|
|
The announcement of these results were made by
Genentech, Inc. from the Phase III MARINA study of the investigational
anti-VEGF drug Lucentis (ranibizumab), which tested 716 patients with
wet age-related macular degeneration (AMD). It was presented at the 23rd
Annual Meeting of the American Society of Retina Specialists (ASRS) in
Montreal, Canada, in July.
Lucentis is a humanized therapeutic antibody
fragment developed at Genentech and designed to bind and inhibit VEGF-A,
a protein that is believed to play a critical role in angiogenesis (the
formation of new blood vessels). Lucentis is designed to block new blood
vessel growth and leakiness, which lead to wet AMD disease progression
and vision loss.
In addition to meeting the studys primary efficacy
endpoint of maintaining vision in patients with wet AMD, secondary
endpoint results show there was a 17 letter (eye chart) difference in
mean change in visual acuity from study entry between patients treated
with Lucentis (regardless of 0.3 mg or 0.5 mg dose) and those in the
control group, as measured by the Early Treatment of Diabetic
Retinopathy (ETDRS) eye chart.
At 12 months, patients treated with Lucentis gained
an average of seven letters in visual acuity compared to study entry,
while those in the control group lost an average of 10.5 letters.
One-year data from the study were presented today during the 23rd Annual
Meeting of the American Society of Retina Specialists (ASRS) in
Montreal, Canada.
"These data are very compelling because, for the
first time, we have a potential treatment which has been shown to
improve vision in a significant number of patients with wet AMD as
opposed to just slowing progression of vision loss," said Joan W.
Miller, M.D., retina specialist at the Massachusetts Eye and Ear
Infirmary who presented the data today.
The Food and Drug Administration last Decemeber
announced the approval of Macugen (pegaptanib sodium injection), a new
therapy to slow vision loss in people with the eye disease neovascular
(wet) age-related macular degeneration (AMD), the major cause of vision
loss in senior citizens.
An analysis of the one-year data showed that
adverse events were similar to those seen in earlier trials of Lucentis.
Common side effects occurring more frequently in the Lucentis arms than
in the control group were mild to moderate and included conjunctival
hemorrhage, eye pain and vitreous floaters. Serious ocular adverse
events occurring more frequently in Lucentis-treated patients were
uncommon (<1 percent) and included uveitis and endophthalmitis. There
appeared to be no imbalance in serious non-ocular adverse events, they
said.
Additional key study findings include:
-
95 percent (452/478) of Lucentis-treated
patients lost fewer than 15 letters compared to baseline, the
primary endpoint of the study, compared with 62 percent (148/238)
for the sham injection control group.
-
25 percent (59/238) of patients treated with
0.3 mg of Lucentis and 34 percent (81/240) treated with 0.5 mg of
Lucentis improved vision by a gain of 15 letters or more compared to
approximately 5 percent (11/238) of patients in the control group.
-
Nearly 40 percent (188/478) of Lucentis-treated
patients achieved a visual acuity score of 20/40 or better at 12
months compared to 11 percent (26/238) in the control group.
"We are very excited that Lucentis has improved vision in patients with
wet AMD and look forward to results of a second Phase III trial," said
Hal Barron, M.D., Genentech senior vice president, development and chief
medical officer. "The magnitude of the treatment effect in this study
suggests that Lucentis could have a major impact on the lives of
patients with wet AMD."
Lucentis is a humanized antibody fragment developed
at Genentech and designed to bind and inhibit Vascular Endothelial
Growth Factor A (VEGF-A), a protein that is believed to play a critical
role in angiogenesis (the formation of new blood vessels). Earlier this
month, Genentech announced it has requested a fast-track designation for
the Lucentis development program in wet AMD. If granted by the U.S. Food
and Drug Administration (FDA), this could enable Genentech to begin a
rolling Biologics License Application filing by the end of 2005.
About the Study
Minimally classic/occult trial of the Anti-VEGF
antibody Ranibizumab (formerly, RhuFab) In the treatment of Neovascular
AMD (MARINA) is a Phase III study of 716 patients in the United States
with minimally classic or occult wet AMD who were randomized 2:1 to
receive intravitreal Lucentis injections or a control regimen. The
control regimen consisted of a sham injection, meaning the treating
physician prepares and anesthetizes the patients eye but does not
perform an injection. Patients treated with Lucentis were further
randomized to receive either a 0.3 mg or 0.5 mg dose of Lucentis once a
month for two years.
Exclusion criteria included prior subfoveal laser
treatment, verteporfin photodynamic therapy (PDT) or experimental
treatments for wet AMD. Patients participating in the MARINA study could
receive PDT therapy if they converted to predominantly classic disease
while on the study or if they had small, active minimally classic or
occult lesions and lost 20 letters or more in visual acuity on two
consecutive physician evaluations. As a result, 11 percent (25/238) of
patients in the control group, 0.4 percent (1/238) of patients in the
Lucentis 0.3 mg group and no patients in the 0.5 mg group received PDT
in the first year of study.
Ongoing Phase III Studies
Genentech and Novartis Pharma AG are conducting an
additional Phase III study of Lucentis, ANCHOR (ANti-VEGF Antibody for
the Treatment of Predominantly Classic CHORoidal Neovascularization in
AMD). This is a randomized, multi-center, double-masked, active
treatment controlled study comparing two different doses of Lucentis to
PDT in 423 patients. The trial is ongoing in the United States, Europe
and Australia in patients with predominantly classic wet AMD. Results
from this study are expected in the fourth quarter of 2005.
Genentech is conducting an additional Phase IIIb
study, PIER (A Phase IIIb, Multicenter, Randomized, Double-Masked, Sham
Injection-Controlled Study of the Efficacy and Safety of Ranibizumab in
Subjects with Subfoveal Choroidal Neovascularization with or without
Classic CNV Secondary to Age-Related Macular Degeneration), a
randomized, double-masked, sham injection-controlled study comparing one
of two doses of Lucentis to sham injections in 184 patients in the
United States with wet AMD. In this trial, Lucentis is administered once
per month for the first three doses followed thereafter by doses once
every three months for two years. Results from this study are expected
in the first quarter of 2006.
Genentech recently began enrollment in the HORIZON
Phase III open-label extension study, which allows eligible patients who
have completed participation in certain other Lucentis clinical studies
to continue to receive the investigational drug.
About Lucentis
Lucentis is being developed by Genentech and the
Novartis Ophthalmics Business Unit. Genentech retains commercial rights
for Lucentis in North America (United States, Canada and Mexico).
Novartis has exclusive commercialization rights for the rest of the
world.
About AMD
AMD is a major cause of painless central visual
loss and is the leading cause of blindness for people over the age of 60
in the United States and Canada. The National Eye Institute estimates
that there are 1.6 million people with AMD in the United States alone
and that this prevalence will grow to 2.95 million by 2020. In Canada,
the Foundation Fighting Blindness estimates that more than 800,000
people are affected by the disease.
AMD occurs in two forms: dry and wet. The dry form
is associated with atrophic cell death of the central retina or macula,
which is required for fine vision used for activities such as reading,
driving or recognizing faces. The wet form is caused by growth of
abnormal blood vessels also known as choroidal neovascularization (CNV)
or ocular angiogenesis under the macula. These vessels leak fluid and
blood and cause scar tissue that destroys the central retina. This
results in a deterioration of sight over a period of months to years.
About Angiogenesis
Genentech is a leader in research and product
development in the area of angiogenesis, the process by which new blood
vessels are formed. In 1989, Napoleone Ferrara, M.D., and a team of
scientists at Genentech conducted seminal work in the field, which
resulted in the identification and cloning of a gene termed Vascular
Endothelial Growth Factor (VEGF), now known as VEGF-A. The VEGF-A
protein is believed to play a critical role in angiogenesis and serves
as one of the key contributors to physiological or pathological
conditions that can stimulate the formation of new blood vessels. The
process of angiogenesis is normally regulated throughout development and
adult life, and the uncontrolled growth of new blood vessels is an
important contributor to a number of pathologic conditions, including
wet AMD.
About Genentech
Genentech is a leading biotechnology company that
discovers, develops, manufactures and commercializes biotherapeutics for
significant unmet medical needs. A considerable number of the currently
approved biotechnology products originated from, or are based on,
Genentech science. Genentech manufactures and commercializes multiple
biotechnology products directly in the United States and licenses
several additional products to other companies. The company has
headquarters in South San Francisco, Calif., and is traded on the New
York Stock Exchange under the symbol DNA. For additional information
about the company, please visit
www.gene.com.
Click to More Senior News on the
Front Page
Copyright: SeniorJournal.com |
