The R&D Tax Credit Aspects of Eye Disease
Approximately 32 million Americans are
affected by eye disease which can be traumatic for many. Eye
disease is usually accompanied by ailments such as depression,
anxiety, and social withdrawal. Diseases such as macular
degeneration, cataracts, abnormal binocular vision, glaucoma,
and Idiopathic Intracranial Hypertension (which leads to loss
of vision) are among those classified as eye disease. As a
result, research is being performed for the prevention and
treatment of eye diseases. Companies researching and
developing new methods of treatment and prevention may be
eligible for federal and state R&D tax credits.
The Research &
Development Tax Credit
Enacted in 1981, the federal Research and
Development (R&D) Tax Credit allows a credit of up to 13%
of eligible spending for new and improved products and
processes. Qualified research must meet the following four
criteria:
- New or improved products,
processes, or software
- Technological in nature
- Elimination of uncertainty
- Process of experimentation
Eligible costs include employee wages, cost of supplies, cost
of testing, contract research expenses, and costs associated
with developing a patent. On January 2, 2013, President Obama
signed the bill extending the R&D Tax Credit for 2012 and
2013 tax years. As of this writing, both the Senate
Committee on Finance and the House Committee on Ways and Means
have recommended extension of the R&D tax credit.
Macular Degeneration
and Identification
Macular degeneration, a common eye
condition and the leading cause of vision loss among people
age 50 and older, is caused by damage to the macula, a small
spot near the center of the retina. Responsible for sharp, central vision, the
macula enables us to see objects that are straight ahead. It
is the most sensitive part of the retina which turns light
into electrical signals and sends them through the optic nerve
where they are translated into images. Risk factors of macular
degeneration include, smoking, race 
(Caucasian people are more prone to the
disease), family history, lack of exercise, irregular blood
pressure or cholesterol, and unhealthy diets. Macular
degeneration is detected by a comprehensive dilated eye exam
which involves a visual acuity test (observation of a standard
eye chart) and the manual examination of dilated eyes. When an
individual's pupils are dilated, observing the back of the eye
becomes much easier.
The Amsler Grid is the most common test for macular
degeneration. Resembling graph paper, the Amsler Grid lines
appear wavy, distorted, or broken when changes in your central
vision occur. Fluorescent angiography is another common test
which uses fluorescent liquid injected into your arm to
observe the blood flow to the retina. This test helps identify
leaking blood vessels which occur in a very progressive type
of macular degeneration. While your eyes are dilated a doctor
may also perform an optical coherence tomography (OCT) in
which 3D images are captured in cross-sections of your retina
using light waves. This test achieves very high resolution
pictures. Figure 1 above illustrates the comparison of normal
vision to macular degeneration vision.
Dry Form
Dry macular degeneration affects approximately 80-90% of
macular degeneration patients. The dry type tends to progress
a lot slower than the wet type and as of yet, there is no
definite and approved treatment. In dry, age-related macular
degeneration, small white or yellowish deposits develop on the
retina and beneath the macula which cause it to deteriorate
over time.
Wet Form
The wet form affects approximately 10-15% of individuals with
age-related macular degeneration. Despite this fact, wet
macular degeneration is the cause of 90% of all cases of
severe vision loss from the disease. In the wet form of the
disease, abnormal blood vessels under the retina grow toward
the macula. Since the new blood vessels are abnormal they tend
to break, bleed, and leak fluid which results in the damaging
of the macula and causes it to lift up and pull away from its
base. As a result, rapid and severe loss of vision tends to
occur.
Treatment
The Implantable Miniature Telescope created by Vision Care
magnifies images while reducing the size of a blind spot
caused by macular degeneration. This FDA approved treatment
for macular degeneration required extensive research and
development to create. Available as of June of 2012, the
Implantable Miniature Telescope is covered by Medicare for
those who have central blindness in both eyes that is
uncorrectable with glasses.
Lucentis is an injectable drug that was approved by the FDA in
June 2006 for treating the wet form of macular degeneration
and is similar to the cancer treatment drug Avastin. Lucentis
inhibits the protein vascular endothelial growth factor (VEGF)
The VEGF blockage helps to stimulate the growth of new blood
vessels and prevent damaged vessels from leaking fluid.
Although strides have been made to improve macular
degeneration treatment, further research and development is
needed to fully understand the disease and create innovative
treatment options.
Stargardt Disease
Stargardt disease is another form of macular degeneration that
begins to damage both eyes in patients between the ages of 6
and 20, although visual impairment may not be apparent until
ages 30 to 40. With this particular disease, vision loss is
usually slow until it reaches 20/40 when it begins to rapidly
decline to 20/200(legal blindness). In 1997, it was discovered
that this disease has a strong genetic component and a family
of genes known as ABC1 genes were found to be involved in
inheriting this disease.
Treatment
In April 2013, the stem cell development company ACT announced
the successful treatment of the first United States patient
with Stargardt disease. The surgery was performed at the Wills
Eye Institute in Philadelphia by Dr. Joseph Maguire and
overseen by Dr. Carl D. Regillo. The patient was injected with
100,000 human embryonic stem cell-derived retinal pigment
epithelial cells. ACT also announced the treatment of the
fifth and sixth patients in the company's macular degeneration
trials.
Abnormal Binocular
Vision
Binocular vision is the use of both eyes
together. The advantages of binocular vision are that it
provides us a spare eye in case one is damaged and also gives
us a wider field of view. Furthermore it gives us binocular
summation which is the ability to detect faint objects more
easily and increases depth perception. Abnormal binocular
vision obstructs the ability for our eyes to work
simultaneously. One example of abnormal binocular vision would
be having a "lazy eye".
Glaucoma
Glaucoma is an eye disorder causing harm to
the optic nerve, the large nerve that is responsible for
vision, resulting in blindness. When an individual has
glaucoma, the pressure changes in the fluid 
circulating the eyeball. This buildup of
pressure inside of the eye is associated with optic nerve
damage. Damage often occurs when the eyes internal fluid
pressure is abnormally high but also can occur if the internal
pressure is measured as normal. Glaucoma currently affects
about 3 million Americans and is five times more prevalent in
African Americans than Caucasians after age 40; however the
risk of glaucoma increases with age for persons of all ethnic
backgrounds. There are two types of glaucoma, open-angle and
acute. Symptoms of open-angle glaucoma include gradual loss of
vision and as it progresses, individuals typically notice loss
of peripheral vision. Once peripheral vision begins to
decline, patients tend to develop tunnel vision, only seeing
directly in front of them. In acute glaucoma symptoms occur
suddenly and may include having blurred vision, halos around
lights during night, haziness in the cornea, pain and redness
in the eye, headaches, nausea, vomiting and extreme weakness.
The prevalence of glaucoma by race is illustrated in Figure 2
below.
Treatment
There is a substantial amount of R&D
occurring for the treatment of glaucoma. One treatment is the
micropulse laser trabeculoplasty (MLT) which promises to
provide pressure lowering treatment with minimal side effects.
MLT treatment uses a specific diode laser with short bursts of
on time and long pauses of off time, the laser can minimize
spikes in eye pressure and inflammation that often occur after
other laser treatments. In addition to MLT, a canaloplasty is
another treatment that is currently being developed.
Canaloplasty is a surgical alternative to the common
trabeculectomy surgery which can lead to infection, leakage,
and irritation. Using the eye's drainage system, a
canaloplasty creates a small incision in the eye to insert a
microcatheter into the eye's natural site of drainage. This
procedure assists in draining fluid to relieve high pressure
inside the eye and improve eye sight.
Cataracts
A cataract is a clouding of the otherwise
clear lens of your eye . In a healthy eye, light can pass
through the lens, the clear tissue behind the pupil, and focus
on the retina. Typically as a result of aging, cataracts develop and the clear lens becomes
cloudy. Once they become large enough, cataracts can interfere
with an individual's every day activity by causing vision
loss. Symptoms of this disorder are decreased or blurred
vision, double vision, seeing halos around lights, or brown
spots in visuals. Cataracts can develop with older age or even
immediately after birth and are the most common eye disease in
the world as Figure 3 depicts.
Treatment
New treatments for cataracts are now
emerging such as lens implants used to repair eyes damaged by
cataracts. Standard intraocular lens (IOL) implants offer
patients improved vision for distance but may not eliminate
the need for reading glasses after surgery. Toric intraocular
lens implants are for patients requiring correction of
astigmatism at the time of cataract. Lastly, accommodative
intraocular lens implants provide the widest range of vision
from distance to near and minimize the need for glasses after
cataract surgery.
Idiopathic
Intracranial Hypertension
Idiopathic intracranial hypertension (IIH)
is a neurological disorder of elevated pressure in the brain
that can result in progressive loss of vision over time.
Symptoms of the disorder include headaches in the back of the
head which tend to be the worst in the morning or at night. As
time progresses the symptoms become more constant and patients
begin to suffer from temporary episodes of visual blurring or
even blindness. Typically IIH occurs in overweight
individuals, especially after a recent weight gain, or even a
pregnancy. Certain medications predispose individuals to the
syndrome such as the antibiotic Tetracycline, steroids (as the
individual weans off), and Vitamin A.
Commercial
Advancements
National Eye
Institute
The age related eye disease study performed by the national
eye institute was initially designed as a long term
multi-center prospective study of the clinical course of age
related macular degeneration and age related cataracts. The
National Eye Institute's study researched the effects of a
high dose vitamin and mineral supplements on healthy
participants 55-80 years old. Large amounts of data have been
studied extensively and have helped in better understanding
these diseases. In November of 2010, 72,000 high quality
photographs of 595 age related eye disease study participants
were made available for research.
Lasik
Surgery
Lasik surgery is a vision correcting
procedure that utilizes a laser. The concerns about the safety
of Lasik procedures have increased lately and as a result,
many companies are developing new equipment to decrease cost
and increase the efficiency of the surgery. Figure 4 above
illustrates the Lasik surgery process.
Rahmani Eye Institute
While the traditional Lasik procedure is effective, Dr Rahmani
performs a cutting edge advanced version of the surgery. The
IntraLasik procedure uses an Intralase computer controlled
laser to create a corneal flap. By using the 5th generation,
most advanced laser on the market, the procedure provides a
new level of safety assurance giving unprecedented control
over the laser.
Abbot Medical Optics
Inc
Abbot plans to introduce a number of new vision products
within the next few years. Being that they are number one in
Lasik surgery, Abbot is expanding its vision care presence in
markets around the world. Abbot Medical Optics' research and
development sector consists of a vision care team that is
knowledgeable, experienced and includes scientists, engineers
and marketing, sales and technical experts. Despite being
heavily involved in the R&D of Lasik surgery equipment
Abbot also is involved in cataract treatments. They have
developed the TECNIS Toric IOL platform which is a lens that
can be used to compensate for corneal spherical aberrations
and corneal astigmatism which are a result of cataracts.
Bausch and Lomb Inc.
Bausch and Lomb is another company at the forefront of the eye
disease treatment field. Similar to Abbot Medical Optics, they
have developed treatments for cataracts and equipment for
Lasik surgery. Additionally, Bausch and Lomb has developed a
vision shaping treatment. This treatment involves wearing
shaping lenses that are custom fitted to the specific contour
of your eyes. Every night these lenses gently reshape your eye
resulting in improvement of vision.
University Research
Bascom Palmer
Eye Institute of Florida
The Bascom Palmer Eye Institute of Florida
has contributed to some of the most vital advancements in the
modern era of eye disease treatment. Diseases involving the
macula are identified, described and classified, as published
in the Bascom Palmer Atlas of Macular Diseases. The institute
is also pioneering the use of Avastin which can be used in the
treatment of age related macular degeneration. Furthermore,
the institute performed the first modified osteo-odonto
keratoprosthesis (OOKP) in the U.S., a surgery for the most
severe cases of corneal and ocular issues and results in
restoring the patient's vision.
Emory University
A recent national study performed by Emory
University revealed an inexpensive drug, Acetazolamide, which
improves vision for patients suffering from mild vison loss
related to idiopathic intracranial hypertension. This National
Eye Institute funded research project was conducted at the
Emory Eye Center. An estimated 100,000 Americans suffer from
IIH and it predominantly affects women of reproductive age who
are also overweight. . University of Iowa professor,
Dr.Michael Wall, states "results show that acetazolamide can
help preserve and actually restore vision for women with IIH,
when combined with a moderate but comprehensive dietary and
lifestyle modification plan."
University of California, San
Francisco
Researchers at the University of California, San Francisco
(UCSF) have found that running assists in the treatment of
eyesight loss. UCSF researchers, in a mice study, found that
when coupled with visual stimulation, running helped to
restore the animal's brain functions that were associated with
sight. Mice with poor eyesight in one eye were given a regimen
of running and visual stimuli exposure which resulted in
significant improvements in their vision. This study may
possibly lead to treatment for certain eye disorders such as a
cataract in a single eye or a droopy eyelid.
University of Maryland
The University of Maryland has been researching a few
treatment options for cataracts. Wearing UV protection sun
glasses and keeping healthy lifestyle habits are essential to
preventing the disease and some medications help delay
cataracts from forming, especially for those with diabetes or
other high risk conditions. There are drug therapies available
for vision treatment include eye drops that contain
phenylephrine and homatropine which are prescribed to dilate
pupils and provide enhanced vision and aldose reductase
inhibitors which help to prevent and delay cataracts in
patients with diabetes. In addition, antibiotics and steroid
eye drops may be prescribed after cataract surgery. There are
also some surgical procedures that can help after the early
stages of cataracts to help replace the cloudy lens that is
formed.
University of North Carolina
In 2013, researchers at the University of North Carolina (UNC)
studied new and more effective treatments for macular
degeneration. MDM2, a UNC developed drug, has conceivable
advantages over other treatments that are being investigated.
Radiation treatment can be used but also causes DNA damage in
cells leading to cell death. MDM2 on the other hand, helps to
activate p53 (a master regulator which determines if a cell
lives or dies) without causing DNA damage.
Conclusion
Eye disease can have serious effects on an
individual's life. Research and development strides are
being made for all eye disease which is resulting in more
effective and advanced treatments. Efforts to innovate
treatment and prevention of eye diseases can be aided by the
federal and state R&D tax credits.
