|
E-mail this page to a friend!
Senior Citizen Health & Medicine
FDA Approves Lucentis for Treatment of Wet
Age-Related Macular Degeneration
Monthly dose can maintain the vision of more than
90% of patients
July 2, 2006 - The Food and Drug Administration has
approved Lucentis (ranibizumab injection) for the treatment of patients
with neovascular (wet) age-related macular degeneration (AMD), the
leading cause of blindness in senior citizens. Lucentis is the first
treatment which, when dosed monthly by injection, can maintain the vision of more
than 90 percent of patients with this type of AMD.
| |
Related Stories |
|
| |
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.
Read more...
Age-Related Macular Degeneration Researchers Focused
on Factor H Gene
By Tucker Sutherland, editor
Aug. 5, 2005 – In March, we reported in
SeniorJournal.com that researchers had discovered a variant of the
Factor H gene is involved in the development of age-related macular
degeneration (AMD), which is the leading cause of blindness in senior
citizens. A month later, another research group found that AMD does
occur when Factor H is triggered, possibly by an infection.
Read more...
Discovery Could Lead to Treatment of Age-Related
Macular Degeneration
Bone Marrow may restore
eye cell damage that
causes AMD
June 9, 2006 - University of Florida scientists
conducting experiments with mice have found evidence that the body
naturally replenishes small amounts of cells in the eye essential for
healthy vision. The finding may shatter the belief that a cell
layer vital for eyesight called the retinal pigment epithelium, or RPE,
is a nonrenewable resource. It is damaged RPE that causes age-related
macular degeneration (AMD), the leading cause of blindness in senior citizens.
Read more...
Betty White Urges Seniors to Get Serious About
Macular Degeneration
To raise awareness of
leading cause of blindness in senior citizens
April 25, 2006 - Today legendary actress Betty
White kicks off "My Eye Health: In the Wink of an Eye," a national
campaign to educate Americans, in particular older ones, about
age-related macular degeneration, also called AMD, and the importance of
early detection and treatment. AMD is the leading cause of blindness in
Americans over age 60.
Read more...
Seniors with Macular Degeneration More Likely to Have
Cognitive Problems
AMD, reduced vision associated with thinking,
memory problems
April 11, 2006 - Older patients with advanced
age-related macular degeneration and reduced vision may be more likely
to also have cognitive impairment, or problems with thinking, learning
and memory, according to a study in the April issue of the Archives of
Ophthalmology, one of the JAMA/Archives journals.
Read more...
Read more
on
Health & Medicine or about
Nutrition, Vitamins, Supplements |
|
Lucentis is a new molecular entity (NME), meaning
it contains an active substance that has never before been approved for
marketing in any form in the United States.
Lucentis will be the first
FDA--approved product to provide prescription information in the new
format for prescription drug package inserts, to provide professionals
and consumers clear and concise prescription information, the FDA also
announced.
The FDA approved Lucentis on Friday after a
Priority Review (six-month).
"This approval is of great importance for the
155,000 Americans who are diagnosed each year with AMD, a common cause
of severe and irreversible vision loss in older adults," said Dr. Andrew
von Eschenbach, Acting Commissioner of Food and Drugs.
"At a time when our elderly population is rapidly
increasing, this product preserves quality of life for those affected by
this disease, helping them to regain the ability to participate in
everyday activities such as reading and driving."
Lucentis manufacturer Genentech, Inc., of South San
Francisco, California, said they began shipping the product as soon as
the approval was received.
AMD, a retinal disease causing severe and
irreversible vision loss, is a major cause of blindness in individuals
older than 55 years. Untreated, the majority of eyes affected with wet
AMD may become functionally impaired. Wet AMD, which accounts for 10
percent of all AMD, is responsible for 80 percent of the associated
vision loss.
The vision loss in wet AMD is caused by the growth
of abnormal leaky blood vessels that eventually damage the area of the
eye responsible for central vision. Lucentis is designed to block new
blood vessel growth and leakiness, which ultimately lead to disease
progression and such vision loss.
Macugen, a drug approved in late 2004, has been
available to slow the development of vision loss.
Lucentis, a biologic product, administered by
injection into the eye, was shown to be safe and clinically effective in
three multicenter, randomized studies of patients representative of the
population usually affected with AMD. In clinical trials, nearly 95
percent of the participants who received a monthly injection maintained
their vision at 12 months compared to approximately 60 percent of
patients who received the control treatment.
Approximately one-third of patients in these trials
had improved vision at 12 months. In a single study carried out for 24
months, these findings have been maintained with continued monthly
dosing. The most commonly reported adverse events included conjunctival
hemorrhage, eye pain, floaters, increased eye pressure and inflammation
of the eye. Serious adverse events were rare and often related to the
injection procedure including endophthalmitis (severe inflammation of
the interior of the eye), intraocular inflammation, retinal detachment,
retinal tear, increased eye pressure and traumatic cataract.
Nearly all patients (95 percent) treated with
Lucentis maintained their vision in the Phase III clinical trials,
according to Genentech. Vision improved by at least three lines (or 15
letters) on the study eye chart in up to 40 percent of these patients at
one year.
Lucentis is designed to inhibit the formation and
leakage of new blood vessels in the back of the eye, the primary cause
of central vision loss associated with this disease.
“Lucentis provides new hope for patients with wet
AMD because it is the first therapy to provide a benefit in vision for a
significant number of patients,” said Arthur D. Levinson, Ph.D.,
Genentech’s chairman and chief executive officer.
“We are proud that the seminal work in angiogenesis
conducted at Genentech, years of clinical study, and the dedication and
commitment of thousands of patients and retina specialists have all
contributed to this important approval.”
“In my opinion, the Lucentis approval stands out as
one of the most important medical developments in ophthalmology during
my 25 years in the field because it has the potential to reverse vision
loss associated with wet AMD,” said Eugene de Juan, M.D., president,
American Society of Retina Specialists.
“We are pleased that Lucentis has been approved by
the FDA and look forward to working with Genentech to provide retina
specialists in the United States with access to Lucentis for patients as
quickly and smoothly as possible.”
The company says the FDA approval of Lucentis is
based on data from two large Phase III clinical trials (MARINA and
ANCHOR). In these studies:
● Nearly all patients (approximately 95 percent)
treated with Lucentis (0.5 mg) maintained (defined as the loss of less
than 15 letters in visual acuity) and up to 40 percent improved (defined
as the gain of 15 letters or more in visual acuity) vision at one year,
as measured on the Early Treatment of Diabetic Retinopathy (ETDRS) eye
chart.
● On average, patients treated with Lucentis in
the MARINA study experienced an improvement from baseline of 6.6 letters
at two years compared to a loss of 14.9 letters in the sham group. In
the ANCHOR study, patients treated with Lucentis, on average,
experienced an 11.3 letter gain from baseline at one year compared to a
loss of 9.5 letters in the Visudyne® photodynamic therapy (PDT) control
group.
● Up to 40 percent of patients treated with
Lucentis achieved vision of 20/40 or better.
In addition to data from the two pivotal studies,
data from the Phase I/II FOCUS and Phase IIIb PIER studies were included
in the FDA review.
Lucentis 0.5 mg is recommended for intravitreal
injection once a month. If monthly injections are not feasible,
treatments can be reduced to one injection every three months after the
first four monthly injections. Compared to continued monthly dosing,
dosing every three months will lead to an approximate five-letter
(one-line) loss of visual acuity benefit, on average, over the following
nine months. Patients should be evaluated regularly.
“Now that Lucentis is approved, we will continue to
work with the retina community to evaluate how patients may be able to
benefit from less frequent dosing, as emerging clinical data indicate
that dosing may need to be tailored to individual patient needs,” said
Levinson.
In clinical trials, the most common adverse
reactions among patients treated with Lucentis (reported in at least 6
percent more patients than in the control groups in at least one study)
included conjunctival hemorrhage, eye pain, vitreous floaters, increased
intraocular pressure and intraocular inflammation.
Although there was a low rate (less than 4 percent)
of arterial thromboembolic events (ATEs) observed in the Lucentis
clinical trials that was not statistically different between the
Lucentis and control groups, there is a theoretical risk of ATEs
following intravitreal use of inhibitors of VEGF. Serious adverse events
related to the injection procedure occurred in less than 0.1 percent of
intravitreal injections, including endophthalmitis, retinal detachments
and traumatic cataracts.
Other serious ocular adverse events observed among
Lucentis-treated patients (that occurred in less than 2 percent of
patients) included intraocular inflammation and increased intraocular
pressure. Lucentis is contraindicated in patients with hypersensitivity
and ocular or periocular infections.
“The impact of wet AMD goes beyond vision loss and
can affect a person’s ability to interact with family and friends,
conduct daily activities and, overall, maintain their independence,”
said Dr. Stephen Rose, chief research officer at the Foundation Fighting
Blindness.
“As an organization dedicated to research for
preventions, treatments and cures for people affected by retinal
degenerative diseases, we applaud the FDA’s approval of Lucentis as an
important advancement in the treatment of wet AMD.”
Lucentis was specifically developed for intraocular
use in the eye to treat the underlying cause of wet AMD by targeting the
molecular pathway that controls the formation of new blood vessels.
Lucentis is 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).
Genentech immediately hosted a webcast discussion
about the product, which is available on their Website until 5 p.m. on
July 7, 2006.
About Lucentis
Lucentis (ranibizumab injection) (0.5 mg) is
approved for the treatment of patients with neovascular (wet) AMD.
Lucentis is a recombinant humanized IgG1 kappa isotype therapeutic
antibody fragment developed for intraocular use.
Lucentis binds to and inhibits the biologic
activity of human 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). VEGF-A has been shown to lead to wet
AMD disease progression and central vision loss. Lucentis was developed
by Genentech and the Novartis Ophthalmics Business Unit for diseases or
disorders of the eye. Genentech retains commercial rights in the United
States and Novartis has exclusive commercial rights for the rest of the
world. For Lucentis prescribing information, please call 1-866-Lucentis
or visit http://www.Lucentis.com.
About AMD
AMD is a major cause of painless central vision
loss and is a leading cause of blindness in people over 55. The
National Eye Institute estimates that there are 1.7 million people with
the advanced form of AMD in the United States alone and that this
prevalence will grow to 2.95 million by 2020. 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 process 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.
Genentech’s Statement on Commitment to Patient
Access
"Genentech is committed to assisting eligible
patients in accessing our therapies for approved indications, regardless
of their ability to pay. Although Genentech’s products are covered by
most government and private insurance, Genentech established the
Genentech® Access to Care Foundation (GATCF) in 1990 for its marketed
products, and donates free product to eligible uninsured patients in the
United States, except for Pulmozyme® (dornase alfa, recombinant), which
is covered by the Genentech Endowment for Cystic Fibrosis. In 2005
alone, GATCF supported over 18,000 patients by providing approximately
$200 million of free product. Genentech recently donated more than $27
million to several independent public charities that provide financial
assistance to eligible patients who cannot access needed medical
treatment due to co-pay costs. To learn more about these independent,
public charities and potential financial assistance options, patients
can speak with an Alternative Funding Specialist from Genentech’s Single
Point of Contact (SPOC) group by calling 866-724-9394 or visiting
http://www.SPOConline.com."
About Genentech
Founded 30 years ago, 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 and
licenses several additional products to other companies. The company
has headquarters in South San Francisco, California and is listed on the
New York Stock Exchange under the symbol DNA. For additional
information about the company, please visit
http://www.gene.com .
Click to More Senior News on the
Front Page
Copyright: SeniorJournal.com |
