Eye treatment:


$50 EYE DRUG EQUAL TO  $2,000
DOSE (AVASTIN VS LUCENTIS)
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.

Sixty percent of Medicare beneficiaries
with macular degeneration took Roche’
s cancer drug Avastin for the disease
in 2008, Philip Rosenfeld, a University
of Miami Miller School of Medicine
ophthalmologist, said in 2011 at a
Senate hearing on drug pricing.
Avastin isn’t FDA-approved for the eye
disorder though it may be prescribed
“off-label” by physicians.

Lucentis costs as much as $2,000 for
each monthly injection compared with
less than $50 a dose of Avastin.  

Yet Lucentis is on track for $1.9 billion
in sales in the U.S. in 2011,  despite
that massive Avastin cannibalization.



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.





BIOSYNTHETIC CORNEA  CURED
THE BLIND
Cornea implants grown in the lab can
restore vision to the blind, according to
early clinical trial results released
today.

The trial, which took place in Sweden,
consisted of 10 adults with blindness
from disease or damage to the cornea,
the transparent outer covering of the
eye. During a two-year follow-up
period, six of the 10 patients who
received the implant saw their vision
improve. In all cases, the body
accepted the new cornea implant,
repopulating it with living cells and
nerve fibers.
There is a worldwide shortage of
donated human corneas. Current
synthetic cornea replacements carry a
high risk of complications and are only
approved for use after multiple human-
tissue transplants have failed.

The new corneal implant is
"biosynthetic," meaning it is created by
a living organism, in this case, yeast.
To make the implant, researchers at
the San Francisco-based company
Fibrogen Inc. genetically engineered
yeast to produce collagen, the protein
that makes up much of the cornea.
The research team then molded the
collagen into a contact-lens shape and
surgically implanted it in one eye of
each of 10 volunteers, who had either
advanced keratoconus (a bulging of
the cornea) or central corneal
scarring. Once implanted, the collagen
acted as a scaffold for the eye's own
cells. Like vines on a trellis, the cells
began to grow on the collagen matrix,
essentially recreating the cornea.

Over a two-year follow-up period, the
cells completely populated the corneal
implant, the researchers report  in the
journal Science Translational
Medicine. The tissue became sensitive
to touch and was covered with a thin
film of protective tears, just like a
healthy cornea. Because their new
corneas were populated with their own
cells, the patients didn't have to take
immune-suppressing drugs to prevent
rejection like most organ recipients.

While six patients showed improved
vision, two others saw no change and
two had their vision get worse. After
surgery, the patients averaged 20/110
vision with glasses. Roughly, that
means they had to stand at a distance
of 20 feet (6 meters) to read
something that someone with normal,
20/20 vision would be able to read at
110 feet (36 meters).
There are several years of more
testing is ahead before this method
can be widely used.

FibroGen is the only producer of highly
purified, fully characterized
recombinant human type III collagen
(rhCIII) intended to replace similar
animal- or human-derived materials
currently used in a variety of medical,
pharmaceutical, and consumer
applications. FibroGen uses
proprietary recombinant methodology
in a yeast expression system with
human DNA sequences to develop
synthetic versions of human collagens
essentially identical to the native
protein. Mixtures of various collagen
types found in animal-sourced
collagen are nearly impossible to
segregate. FibroGen has been able to
produce specific types of recombinant
human collagen (e.g., types I or III)
consistently and reproducibly.
FibroGen has developed simple,
scalable purification processes that
provide highly purified and
reproducible lots of protein in any
desired quantity, and employs a series
of rigorous analytical tests to ensure
lot-to-lot consistency and high quality.




MICROPLASMIN: A DRUG USED IN
EYE TREATMENT FOR VMA AND MH
A Phase III trial of a drug used for the
treatment of vitreomacular adhesion
(VMA) and macular hole (MH) revealed
key findings for patients diagnosed
with these severe conditions which can
lead to significant vision impairment.

Vitreomacular adhesion (traction) is a
condition in which the vitreous gel has
an abnormally strong adhesion to the
retina that could lead to decreased or
distorted central vision. Vitreomacular
adhesion  can also lead to sight
threatening conditions such as
macular holes or macular edema.

Dr. Matthew Benz, retinal surgeon at
the Methodist Hospital in Houston,
presented the data of the microplasmin
trial (no: NCT00781859) on behalf of
ThromboGenics NV (Belgium), at the
World Ophthalmology Congress in
Berlin.
The trial recruited 326 patients at 42
centers in the United States, and Benz
is the primary investigator at
Methodist. In his presentation, Benz
reported that in the study, 27.7
percent of the 220 patients treated
with the in-office injection of
microplasmin had their VMA corrected,
compared to 13.2 percent of the 106
patients who received a placebo
injection. Untreated, VMA can cause
distortion and blurring of central vision.
Current treatment includes either
observation or surgery.

Study investigators also discovered
that patients diagnosed with certain
types of macular holes, a severe
condition which can lead to irreversible
vision impairment including central
blindness, could benefit from the same
drug.

In this group, 45.6 percent of the 52
patients with smaller macular holes
were cured with a single injection of
microplasmin without the need for eye
surgery in the six months after
treatment. This compared with 15.6
percent of the 32 patients in the
placebo group.



ILUVIEN: AIMED AT TREATING EYE
DIABETIC MACULAR EDEMA
In November 2011  the Food and Drug
Administration refused to approve
Iluvien, a time-release injection that is
intended to treat diabetic macular
edema, which can cause blurred vision
and blindness. The agency said the
drug's potential benefits didn't
outweigh its side effects, and said
Alimera will need to run two more
clinical trials to win approval.

Analysts said  that they are not sure
what Alimera's next step will be.

Biopharmaceutical company Alimera
Sciences Inc.   submitted a new drug
application for its sustained drug
delivery system Iluvien aimed at
treating diabetic macular edema
(DME), a primary cause of vision loss
associated with diabetic retinopathy.
The sustained drug delivery system
releases tiny quantities of fluocinolone
acetonide for DME.

Iluvien is developed by the Australian
company: drug delivery products
maker pSivida Corp. and was licensed
to Alimera Sciences in 2005.

Diabetic macular edema is the swelling
of the retina in diabetes mellitus due to
leaking of fluid from blood vessels
within the macula, the central portion
of the retina, the specialized nerve
endings that detect color and upon
which daytime vision depends. Macular
edema in common in diabetes, with the
lifetime risk for diabetics to develop
macular edema at about 10%.




GLAUCOMA PROCEDURE TESTED
USING ULTRASOUND
EyeTechCare trials ultrasound
glaucoma procedure.
French company EyeTechCare is
performing clinical trials at Edouard
Herriot Hospital in Lyon on a new
medical technology called EyeOP1 that
directs finely focused ultrasound
beams into the ciliary bodies of a
patient's eye through miniaturised
transducers in a ring-shape probe.
The beams pass through eye tissue
without disruption and reach the target
area through the focal point, which has
a volume of less than 0.3mm.
According to the company, the
procedure can be administered on an
outpatient basis under local
anaesthesia and it takes around one
minute. A typical procedure will require
the patient to lie down close to the
EyeOP1 command module and the
disposable therapy device will be
placed on the globe of the eyeball.
the main objective of all glaucoma
treatments is to decrease the intra-
ocular pressure, which is the is the
fluid pressure of the aqueous humor
inside the eye. With traditional surgery,
this involves using either a laser
treatment or making cuts in the eye to
reduce the pressure. A surgeon will
need to strike the circumference of the
eye between 20 and 40 times to be
effective.
EyeTechCare claims that these
multiple applications are an occasional
source of error and always lack
reproducibility.
The difference with this company's
method is that the circular EyeOP1
device is capable of treating the entire
circumference of the eye. The device
incorporates six transducers, which are
among the smallest ever manufactured
for therapeutic applications, and each
one is activated around the
circumference sequentially.
With the success of clinical trials
currently being undertaken on a dozen
patients in Lyon, EyeTechCare is then
hoping to do even more extensive
trials of the device in 15 centres
across Europe with a minimum of 100
patients.


STEM CELLS HEAL BURN- DAMAGED
EYE
Cultured limbal stem cells taken from
the  uninjured eye of the same patient
can be transplanted to a burn-
damaged eye to regenerate new
corneal epithelium, according to a
study published online in the New
England Journal of Medicine.
Paolo Rama, M.D., of the San Raffaele
Scientific Institute in Milan, Italy, and
colleagues treated 112 patients with
corneal damage, most with burn-
dependent limbal stem-cell deficiency,
with the transplantation of autologous
limbal cells cultivated on fibrin.
The researchers observed permanent
restoration of transparent, self-
renewing corneal epithelium in 76.6
percent of cases, with failures
apparent in the initial year. In up to 10
years of follow-up, restored eyes
remained stable.
Currently, people with eye burns can
get an artificial cornea, a procedure
that carries such complications as
infection and glaucoma, or they can
receive a transplant using stem cells
from a cadaver, but that requires
taking drugs to prevent rejection.


A TINY STENT IMPLANTED INTO THE
EYE TO TREAT GLAUCOMA
Surgeons at the Cathedral Eye Clinic
in Belfast fitted a patient's eye with a
device already being dubbed the
'millimetre miracle'.
The tube, a 'stent', is implanted into
the eye and siphons off excess fluid
that can lead to the blinding eye
condition called Glaucoma.
The iStent is a tiny piece of titanium
weighing just 60 microgrammes - and
is the smallest medical device ever to
be implanted into the human body.
The iStent was designed by California-
based company Glaukos and it is also
available in Canada, France,
Germany, Italy and Spain.

GLAUKOS

LASIK PROCEDURE  IS GETTING A
POSSIBLE COMPETITOR
An alternative to laser eye surgery:
A plastic lens implanted into the eye
could boost the vision of thousands
with near sightedness.
New research suggests the procedure
is at  least as effective as laser surgery
- in some cases, even more so.
It is also safer. The tiny lens alters the
angle at which light enters the eye,
helping it to focus clearly. It takes just
15 minutes to implant and never
needs to be replaced.
The procedure closely resembles that
for cataract surgery, where a surgeon
removes the eye's cloudy lens and
replaces it with an artificial one.
A disadvantage is cost: around
USD 4,500.00 per eye in the UK-
almost double that of laser surgery.


FEMTOSECOND LASER IMPROVES
ON CATARACT SURGERY
The  lasers deliver a benefit that's
difficult to achieve with traditional
techniques. They can create a
perfectly round, perfectly centered
opening in the front of the bag that
holds the cataractous lens.
Currently only  one company, LenSx of
Aliso Viejo, Calif., holds FDA approval
to market a femtosecond laser.


OTHER DEVELOPMENTS
Drug: Ozurdex by Allergan for the
treatment of macular edema;

Bepreve eye drops by Ista for allergic
itching;

CXL: Corneal collagen crosslinking
with Riboflavin can stop the
progression of keratoconus and
ecstasia;

Stem cell treatment eye: corneal
disease;

Contact lense transfering stem cells
trial;

Stem cells turned into retinal pigment
epithelium (RPE) cells trial;

Advanced Cell Technology;

Procedure: Trabectome for glaucoma
by Neomedix Corp;

Drugs: Lucentis by Genentech or
Avastin for wet macular degeneration;

Tß4 (RGN-259 eye drops) by
Regenerx to protect eye from toxic
chemicals in clinical  trial;