AMD (age-related macular
degeneration) of the eye:

Macular degeneration is an eye
disorder that damages the center of
the retina, which is called the macula.
This makes it difficult to see fine details


$50 EYE DRUG EQUAL TO  $2,000
DOSE
An expensive eye injection that’s
approved to treat macular
degeneration — the most common
cause of age-related blindness —
works no better than a much cheaper
drug at preventing vision loss. That’s
the finding of a long-awaited study
published online in April 2011 by the
New England Journal of Medicine.

The study, involving more than 1,200
patients with the “wet’’ form of macular
degeneration, found no difference
between those who were randomly
treated for one year with the more
expensive drug Lucentis — which
costs about $2,000 a dose — and the
cheaper drug Avastin, which costs $50.

For about five years, doctors have
been treating most macular
degeneration patients “off-label’’ with
Avastin (bevacizumab), which is
primarily a cancer treatment, since it’s
chemically similar to Lucentis
(ranibizumab). They use a fraction of
the dose given cancer patients.
But there was always uncertainty as to
whether it was just as safe and
effective. Experts say the new study
indicates that it is.

Lucentis, which  inhibits blood-vessel
formation, was approved in  2006 to
treat wet AMD. It is chemically similar to
Roche's cancer drug Avastin, and
some physicians have opted to use
Avastin because it is much cheaper at
doses needed for the eye.
A recent government study found that
Medicare pays $1,593 a dose for
Lucentis, compared with $42 a dose
for Avastin.

Avastin is widely used—it is estimated
that the drug already has a 60% to
65% share of the AMD market in the
U.S.


FDA APPROVES REGENERON EYE
DRUG EYLEA  FOR  WET MACULAR
DEGENERATION
In November 2011 the FDA approved
Eylea (aflibercept) to treat patients with
wet (neovascular) age-related macular
degeneration (AMD), a leading cause
of vision loss and blindness in
Americans ages 60 and older.

AMD gradually destroys a person's
sharp, central vision. It affects the
macula, the part of the eye that allows
people to see fine detail needed to do
daily tasks such as reading and driving.

There are two forms of AMD, a wet
form and a dry form. The wet form of
AMD includes the growth of abnormal
blood vessels. The blood vessels can
leak fluid into the central part of the
retina, also known as the macula.
When fluid leaks into the macula, the
macula thickens and vision loss
occurs. An early symptom of wet AMD
occurs when straight lines appear to
be wavy.

The safety and effectiveness of Eylea
was evaluated in two clinical trials
involving 2,412 adult patients. People
in the study received either Eylea or
Lucentis (ranibizumab injection). The
primary endpoint in each study was a
patient's clearness of vision (visual
acuity) after one year of treatment.

Eylea is injected into the eye either
every four weeks or every eight weeks
by an ophthalmologist. The studies
showed that Eylea was as effective as
Lucentis in maintaining or improving
visual acuity.

Eylea competes with Lucentis from
Basel, Switzerland-based Roche
Holding AG.  Eylea is injected every
eight weeks, half as often as Lucentis.
The less frequent dosing would
possibly help Regeneron capture 25
percent of the U.S. market from
Lucentis.





MINIATURE TELESCOPE BY
VISIONCARE
A tiny telescope that's implanted in an
eye affected by advanced age-related
macular degeneration (AMD) has been
approved by the U.S. Food and Drug
Administration.

The Implantable Miniature Telescope
replaces the natural lens and
magnifies an image more than two
times.
The device is meant for people aged
75 and older who have blind spots
associated with end-stage AMD.
Candidates will be trained with an
external telescopic device to see if
they may benefit from the implanted
product, the agency said.

The device made by VisionCare
Ophthalmic Technologies is aimed at
about 750,000 people in the United
States who have the most severe and
untreatable form of the disease, which
causes a blind spot in the center of
their vision.

The device — which is about the size
of a pea — is implanted in an
outpatient procedure behind the
colored portion of the eye known as
the iris after the patient's own lens is
removed.
By magnifying vision by 2.2 times to
2.7 times, depending on which model
is used, the device projects visual
images away from the damaged
macula and onto the surrounding
healthy retinal tissue. It is placed in
only one eye, since the patient's other
eye is needed for peripheral vision.

In a study involving more than 200
patients implanted with the device, the
FDA said, 75 percent "improved their
level of vision from severe or profound
impairment to moderate impairment."



NEOVISTA'S NEW PROCEDURE CAN
CURE THE PROBLEM FOR GOOD
A new procedure in trial for wet
age-related macular degeneration:
epimacular brachytherapy - developed
by NeoVista, can cure the problem for
good. It uses radiation beams to 'burn'
the abnormal blood vessels growing
behind the retina.The  epimacular
brachytherapy device delivers the
peak dose of strontium-90  beta-
ionizing radiation directly to the lesion
in an effort to minimize exposure to the
surrounding tissue.


OTHER DEVELOPMENTS

Photocoagulation uses a high-energy
laser to destroy leaking blood vessels
and photodynamic therapy;

Lipshitz Macular Implant (LMI): sight
can be restored for patients with either
the wet or dry form of AMD;