Month: June 2013

Taking a combination of vitamins B6 and B12 and folic acid appears to decrease the risk of age-related macular degeneration in women, according to a report in the February 23 issue of Archives of Internal Medicine, one of the JAMA/Archives journals.

Age-related macular degeneration (AMD) is a leading cause of vision loss in older Americans, according to background information in the article. Treatment options exist for those with severe cases of the disease, but the only known prevention method is to avoid smoking. Recent studies have drawn a connection between AMD and blood levels of homocysteine, an amino acid. High levels of homocysteine are associated with dysfunction of the blood vessel lining, whereas treatment with vitamin B6, vitamin B12 and folic acid appears to reduce homocysteine levels and may reverse this blood vessel dysfunction.

William G. Christen, Sc.D., of Brigham and Women’s Hospital and Harvard Medical School, Boston, and colleagues conducted a randomized, double-blind clinical trial involving 5,442 women age 40 and older who already had heart disease or at least three risk factors. Of these, 5,205 did not have AMD at the beginning of the study. In April 1998, these women were randomly assigned to take a placebo or a combination of folic acid (2.5 milligrams per day), pyridoxine hydrochloride (vitamin B6, 50 milligrams per day) and cyanocobalamin (vitamin B12, 1 milligram per day). Participants continued the therapy through July 2005 and were tracked for the development of AMD through November 2005.

Over an average of 7.3 years of treatment and follow-up, 137 new cases of AMD were documented, including 70 cases that were visually significant (resulting in a visual acuity of 20/30 or worse). Of these, 55 AMD cases, 26 visually significant, occurred in the 2,607 women in the active treatment group, whereas 82 of the 2,598 women in the placebo group developed AMD, 44 cases of which were visually significant. Women taking the supplements had a 34 percent lower risk of any AMD and a 41 percent lower risk of visually significant AMD. “The beneficial effect of treatment began to emerge at approximately two years of follow-up and persisted throughout the trial,” the authors write.

“The trial findings reported herein are the strongest evidence to date in support of a possible beneficial effect of folic acid and B vitamin supplements in AMD prevention,” the authors write. Because they apply to the early stages of disease development, they appear to represent the first identified way-other than not smoking-to reduce the risk of AMD in individuals at an average risk. “From a public health perspective, this is particularly important because persons with early AMD are at increased risk of developing advanced AMD, the leading cause of severe, irreversible vision loss in older Americans.”

Beyond lowering homocysteine levels, potential mechanisms for the effectiveness of B vitamins and folic acid in preventing AMD include antioxidant effects and improved function of blood vessels in the eye, they note.

Arch Intern Med. 2009;169[4]:335-341.

Archives of Internal Medicine

Cellgate Inc., a company
developing novel anti-proliferative drugs to combat disease, has dosed the
first patient in a Phase I dose-escalation study of CGC-11047 in patients
with age-related macular degeneration (AMD). CGC-11047 is a novel polyamine
analog that targets the hyper-proliferating blood vessel growth, known as
choroidal neovascularization (CNV), associated with AMD.

The open label Phase I trial is designed to determine the safety and
tolerability of CGC-11047 in patients with age-related macular
degeneration. A total of fifteen patients will be treated in cohorts of
escalating doses. Patients will be treated subconjunctivally, avoiding the
need to inject into the eye. Patients will be monitored for adverse events
and for preliminary evidence of suppression and regression of choroidal
neovascularization following administration of CGC-11047. Peter
Campochiaro, M.D., Professor of Opthalmology at the Wilmer Eye Institute of
the Johns Hopkins School of Medicine is the primary investigator of the
study.

“This is the second indication for CGC-11047 to enter the clinic, and
we believe CGC-11047’s potent anti-proliferative properties, distinct
mechanism of action and ease of administration will make it an excellent
drug candidate for this disease setting,” said Edward F. Schnipper, M.D.,
President and Chief Executive Officer of Cellgate. “The potential we’ve
observed for CGC-11047 to impede the blood vessel growth underlying AMD and
to improve vision distinguish it from that of existing treatments. In
addition, CGC-11047 may be complementary to other recently approved AMD
therapeutics and its less invasive subconjunctival route of administration
will provide an appealing patient benefit.”

About CGC-11047

CGC-11047 is a polyamine analog that targets hyper-proliferating cells
to halt cell growth and induce apoptosis. Polyamines are cell components
considered essential for cell proliferation and differentiation. Cellgate’s
compounds are believed to work by displacing polyamines from their natural
binding sites and preventing cell replication. In preclinical models of
AMD, CGC-11047 has demonstrated the ability to suppress the growth of
vascular lesions under the retina, as well as to cause a regression of the
neovascular swelling and leakage that result in a loss of central vision.

Cellgate is also developing the anti-proliferative compound CGC-11047
for the treatment of certain cancers using a different dose formulation. A
Phase I clinical trial of CGC-11047 in individual combinations with a
variety of standard chemotherapeutics is ongoing in advanced solid tumor
malignancies or lymphomas and a Phase II clinical trial has recently been
initiated among hormone-refractory prostate cancer patients.

About Age-related Macular Degeneration

Age-related macular degeneration (AMD) is a chronic, progressive
condition and is the leading cause of vision loss in adults over 55 in the
U.S. AMD is characterized by the gradual loss of sharp, central vision and
the ability to see fine detail. AMD can occur in two forms: dry and wet,
with approximately ten percent of dry AMD progressing to the more severe or
advanced form of wet, or neovascularizing, macular degeneration. In wet
AMD, new blood vessels form below the central portion of the retina, known
as the macula. Swelling and leakage from these new blood vessels damages
the macula, resulting in the development of blind spots, distorted vision,
and even severe central vision loss. Neovascular AMD is estimated to affect
more than 1.7 million people in the U.S. alone and this number is
increasing as the population ages. There is currently no cure for macular
degeneration, though laser surgery, photodynamic therapy and emerging drug
treatments have been shown to help slow disease progression.

About Cellgate

Cellgate Inc. is a privately-held company advancing a portfolio of
anti-proliferative therapeutics with the potential to address a number of
diseases, including cancer and age-related macular degeneration, in which
uncontrolled cell division is an underlying cause. The company’s lead
products are advanced polyamine analogs that act by selectively targeting
proliferating cells and inducing cell death to halt the progress of
disease. Cellgate has two polyamine analog compounds, CGC-11047 and
CGC-11093, currently in Phase II and Phase I clinical trials with leading
investigators. In addition, Cellgate has established a portfolio of
promising anti-proliferative leads undergoing preclinical evaluation. For
more information about Cellgate, please visit cellgate.

Cellgate Inc.
cellgate

View drug information on Photodynamic Therapy.

Mark E. Hammer, MD has become president of the American Retina Foundation (ARF), the charitable arm of the American Society of Retina Specialists (ASRS).

A partner in the Tampa-based private practice of Retina Associates of Florida, Dr. Hammer is vitreoretinal specialist with more than 25 years experience in the diagnosis, treatment and research of macular degeneration, diabetic retinopathy, retinal vein occlusions, and other retinal diseases. He is also a clinical associate with the University of South Florida’s school of ophthalmology and has published numerous professional papers and lectured extensively on retinal diseases and treatment.

Dr. Hammer is a graduate of Yale University, Columbia University and the Columbia College of Physicians and Surgeons. He served his residency in ophthalmology at the New York Eye and Ear Infirmary and completed his Vitreoretinal Diseases Fellowship at the Devers Eye Clinic. Additionally, Dr. Hammer recently earned a master’s in business administration from the University of South Florida.

In addition to the American Society of Retina Specialists, he is a member of the Retina Society, American Academy of Ophthalmology, American Board of Ophthalmology, American Uveitis Society, and the National Board of Medical Examiners.

Source:

American Society of Retina Specialists

Two distinguished ophthalmologists have received the American Academy of Ophthalmology’s Outstanding Humanitarian Service Award, presented November 11 at the Academy’s 2007 Annual Meeting, held in New Orleans.

Alessandro Pezzola, MD, and Paul G. Steinkuller, MD, were recognized for their participation in charitable activities, indigent care, community service and other humanitarian activities in providing services to the poor and needy populations around the world.

“Dr. Pezzolla and Dr. Steinkuller have made tremendous contributions that have bettered the health of people who did not have access to quality eye care,” said C.P. Wilkinson, MD, president of the Academy. “We are proud to honor them for their dedication, leadership, and commitment to providing services to the poor and needy populations around the world.”

Building for a Cause

Since 1987, Dr. Pezzola has been volunteering his services to organize, raise funds, and build several rural hospitals dedicated to eye surgery for disadvantaged, indigent people living in developing countries.

Dr. Pezzola sacrificed his career, his private clinical practice, his income and his health for his humanitarian service. He has helped the poorest people of the world restore vision through examinations, therapy, and thousands of surgical procedures. Dr Pezzola has been involved in projects in a number of countries, including Zaire, the Ivory Coast, and Ghana. He is currently working on a project in Indonesia and Mali.

Dr. Pezzola is one of the founding members of Una Sola Vita Foundation, a non-profit association in Italy. The foundation’s primary goal is to provide health care assistance to developing countries without any political, social, or religious prejudice by implementing medical-health programs, building new hospitals, creating medical-surgical prevention programs and training medical and paramedic personnel.

In Zaire, Dr. Pezzola was instrumental in starting an ophthalmic day surgery unit in the villages of Kamituga, Walungu, and Kiwu. This was a particularly difficult mission with rain and floods isolating the team; despite these challenges, over 2,000 patients were treated, 100 of them surgically.

Dr. Pezzola’s mission in Ghana began with the creation of an eye unit and surgical center inside the Comboni clinic. He later was involved with starting the eye surgery clinic at the St. Patrick’s hospital in Maase and most recently he began setting up an ambulatory-based ophthalmic surgical unit in the poorest area of Lombok, Indonesia. Blindness prevention for the poor will be the main goal at this clinic. So far, 1,900 patients have been examined and 200 patients have been operated on. Dr. Pezzola continues to divide his time between his practice in Italy and his missions in developing countries. “

African Mission

Almost half of the over twenty-five years that Dr. Steinkuller has practiced in the field of pediatric ophthalmology were spent caring for the underserved and underprivileged in Africa.

From 1981 to 1983, Dr. Steinkuller worked for a United States Agency for International Development (USAID) project, the “Kenya Rural Blindness Prevention Project,” which was part of a population-based ocular disease survey of 12,000 people. His work on this project included examining inhabitants of rural villages in geographically distinct regions. This sampling study was, and still is, the largest study of its kind ever done in sub-Saharan Africa.

From 1985 to1987, Dr. Steinkuller worked on another USAID project, the “Malawi Childhood Blindness and Mortality Prevention Project”. During this time, Malawi children were found to be at the high risk for vitamin A deficiency, with secondary blindness and death. Dr. Steinkuller worked with the local Ministry of Health and village authorities who were in charge of vitamin A distribution, diet, and farming.

From 1998 to 2004, Dr. Steinkuller worked for Christian Blind Mission (CBM), an international Christian medical organization. CBM’s primary purpose is to improve the quality of life of the world’s poorest persons with disabilities and those at risk of disability. CBM has been involved in more than a thousand supported projects in 113 developing countries.

In the villages of Madagascar, Dr. Steinkuller focused on reducing the extent of cataract blindness. He trained general physicians to do medical ophthalmology, IOL procedures and glaucoma surgery. At the time, there were only twelve ophthalmologists for seventeen million people. Dr. Steinkuller trained Malagasy physicians, as well ophthalmologists, three of whom are now teaching in that country. His efforts will soon have doubled the number of ophthalmologists in Madagascar. Most importantly, his training program has provided people in remote rural areas access to high quality eye care. In 2004, Dr. Steinkuller received the Chevalier Award from the government of Madagascar for his excellence in training ophthalmology.

Living in Africa entailed risks. Dr. Steinkuller suffered from malaria several times, and during his stay Madagascar erupted in violent unrest lasting six months. Upon his return from Africa, Dr. Steinkuller re-joined the faculty at the Baylor College of Medicine Department of Ophthalmology, training residents and fellows in pediatric ophthalmology. He has been recognized by the Department four times, receiving the Best Teacher Award in 1991, 1996, 1998, and 2007.

About the American Academy of Ophthalmology

AAO is the world’s largest association of eye physicians and surgeons – Eye M.D.s – with more than 27,000 members worldwide. Eye health care is provided by the three “O’s” – opticians, optometrists and ophthalmologists. It is the ophthalmologist, or Eye M.D., who can treat it all: eye diseases and injuries, and perform eye surgery. To find an Eye M.D. in your area, visit the Academy’s Web site at aao.

Human beings far outpace computers in their ability to recognize faces and other objects, handling with ease variations in size, color, orientation, lighting conditions and other factors. But how our brains handle this visual processing isn’t known in much detail. Researchers at Children’s Hospital Boston, taking advantage of brain mapping in patients about to undergo surgery for epilepsy, demonstrate for the first time that the brain, at a very early processing stage, can recognize objects under a variety of conditions very rapidly. The findings were published in the journal Neuron on April 30th.

Visual information flows from the retina of the eye up through a hierarchy of visual areas in the brain, finally reaching the temporal lobe. The temporal lobe, which is ultimately responsible for our visual recognition capacity and our visual perceptions, also signals back to earlier processing areas. This cross-talk solidifies visual perception.

“What hasn’t been entirely clear is the relative contribution of these “feed-forward” and “feed-back” signals,” says Gabriel Kreiman, PhD, of the Department of Ophthalmology at Children’s Hospital Boston and the study’s senior investigator. “Some people think that if you don’t have feedback, you don’t have vision. But we’ve shown that there is an initial wave of activity that gives a quick initial impression that’s already very powerful.”

Although feedback from higher brain areas may occur later and is often important, very fast visual processing would have an evolutionary advantage in critical situations, such as encountering a predator, Kreiman adds.

Previous human studies have relied on noninvasive brain monitoring, either with electrodes placed on the surface of the head or with imaging techniques, and have captured brain activity at intervals of seconds – lagging considerably behind the brain’s actual processing speeds. Moreover, these techniques gather data from fairly general brain locations. By placing electrodes directly on the brain, the Children’s researchers were able to obtain data at extremely high temporal resolution – picking up signals as fast as 100 milliseconds (thousandths of seconds) after presentation of a visual stimulus – and monitor activity in very discrete, specific locations.

Kreiman collaborated with Children’s neurosurgeon Joseph Madsen, MD, who was already doing brain mapping in patients with epilepsy, a procedure that ensures that surgery to remove damaged brain tissue will not harm essential brain functions. The team implanted electrodes in the brains of each of 11 adolescents and young adults with epilepsy (anywhere from 48 to 126 electrodes per patient) in the areas where their seizures were believed to originate. While the electrodes recorded brain activity, the patients were presented with a series of images from five different categories – animals, chairs, human faces, fruits and vehicles – of different sizes and degrees of rotation.

The recordings demonstrated that certain areas of the brain’s visual cortex selectively recognize certain categories of objects, responding so strongly and consistently that the researchers could use mathematical algorithms to determine what patients were viewing, just by examining their pattern of neural responses. Moreover, these responses occurred regardless of the object’s scale or degree of rotation. And recognition was evident within as little as 100 milliseconds, too fast for information to be relayed from the visual cortex to the temporal lobe and back again.

Kreiman and Madsen are now extending these studies by showing patients movies – more closely resembling the way we see images in real life. Since each patient is allowed to choose his or her own movie, Kreiman’s team must analyze its visual content frame by frame and then link that data to the patient’s brain activity.

Why is it important to tease apart visual processing in this way? Kreiman envisions using the vision algorithms discovered in humans to teaching computers how to see as well as people, so that they could help in real-life applications such as spotting terrorists in airports, helping drivers avoid collisions with hard-to-see pedestrians, or analyzing hundreds of tumor samples looking for malignancy. A more futuristic application would be the design of brain-computer interfaces that would allow people with visual impairment to have at least partial visual perception.

Over the last decade, Kreiman and Itzhak Fried, MD, PhD, of UCLA have studied the hippocampus, which is involved in memory, and found individual brain cells that responded consistently when people were shown specific images such as pictures of Jennifer Aniston and Bill Clinton. Kreiman is interested in further exploring the relation between visual processing and memory and incorporating the physiological knowledge into computational algorithms.

The current study was funded by the Epilepsy Foundation, the Whitehall Foundation, the Klingenstein Fund and the Children’s Hospital Boston Ophthalmology Foundation.

Citation: Liu H; et al. Timing, timing, timing: Fast decoding of object information from intracranial field potentials in human visual cortex. Neuron (2009), doi:10.1016/j.neuron.2009.02.025.

Source:
Rob Graham

Children’s Hospital Boston

Bayer HealthCare AG and Regeneron
Pharmaceuticals, Inc. (NASDAQ: REGN) announced that the first patient
has been dosed in the VIEW 2 trial, a second Phase 3 clinical study in a
development program evaluating VEGF Trap-Eye for the treatment of the
neovascular form of Age-related Macular Degeneration (wet AMD), a leading
cause of blindness in adults.

VIEW 2 (VEGF Trap-Eye: Investigation of Efficacy and Safety in Wet AMD)
will enroll approximately 1,200 patients in up to 200 centers in Europe,
Asia Pacific, Japan and Latin America. The first Phase 3 trial, VIEW 1,
began enrolling patients in August 2007 in the United States and Canada.
Both VIEW 1 and VIEW 2 are designed to evaluate the efficacy and safety of
VEGF Trap-Eye administered by intravitreal injection, at dosing intervals
of 4 and 8 weeks. The development program will include visual acuity
endpoints and anatomical endpoints, including retinal thickness, a measure
of disease activity. The trial is intended to establish non-inferiority of
VEGF Trap-Eye with Lucentis(R)* (ranibizumab), an antiangiogenic agent
approved for use in wet AMD in major markets globally.

Wet AMD accounts for about 90 percent of all severe AMD-related vision
loss. It occurs when abnormal blood vessels in the eye leak fluid and blood
into the macula, the area of the retina that allows for vision of fine
details. This can lead to a rapid loss of central vision with continued
progression.

“Results from the Phase 2 study have shown that VEGF Trap-Eye has the
potential to significantly reduce retinal thickness and improve vision,”
said Kemal Malik, MD, Head of Global Development and member of the Bayer
HealthCare Executive Committee. “Dosing of the first patient in this
confirmatory Phase 3 trial is an important milestone for this compound
intended to treat a devastating ocular disease that impacts millions of
people worldwide.”

“New therapies are still needed to provide optimal care to those
patients with wet AMD,” said George D. Yancopoulos, M.D., Ph.D., President
of Regeneron Research Laboratories. “This global Phase 3 clinical program
will provide additional data to further evaluate the efficacy and safety of
VEGF Trap-Eye using different dosing regimens.”

Bayer HealthCare and Regeneron are collaborating on the global
development of VEGF Trap-Eye for treatment of wet AMD, diabetic eye
diseases, and other ocular diseases and disorders. Once approved, Bayer
HealthCare will market VEGF Trap-Eye outside the U.S., where the parties
will share equally in profits from any future sales of VEGF Trap-Eye.
Regeneron maintains exclusive rights to VEGF Trap-Eye in the U.S. VIEW 2
primary analysis results are anticipated in 2011.

About VIEW 2

In the first year, the VIEW 2 (VEGF Trap-Eye: Investigation of Efficacy
and Safety in Wet AMD) study will evaluate the safety and efficacy of VEGF
Trap-Eye at doses of 0.5 milligrams (mg) and 2.0 mg administered at 4-week
intervals and 2.0 mg at an 8-week dosing interval, including one additional
2.0 mg dose at week four. Patients randomized to the ranibizumab arm of the
trial will receive a 0.5 mg dose every 4 weeks. After the first year of
treatment, patients will continue to be followed and treated for another
year on a flexible, criteria-based extended regimen with a dose
administered at least every 12 weeks, but not more often than every 4 weeks
until the end of the study.

The primary endpoint of the study is the proportion of patients treated
with VEGF Trap-Eye who maintain vision at the end of one year, compared to
ranibizumab patients. Visual acuity is defined as the total number of
letters read correctly on the Early Treatment Diabetic Retinopathy Study
(ETDRS) chart, a standard chart used in research to measure visual acuity.
Maintenance of vision is defined as losing fewer than three lines
(equivalent to 15 letters) on the ETDRS chart. Key secondary endpoints
include the mean change from baseline in visual acuity as measured by ETDRS
and the proportion of patients who gained at least 15 letters of vision at
week 52.

Phase 2 Clinical Data

In a Phase 2 trial in 157 patients, announced in October 2007 at the
Retina Society Conference in Boston, VEGF Trap-Eye met both primary and
secondary key endpoints: a statistically significant reduction in retinal
thickness (a measure of disease activity) after 12 weeks of treatment
compared with baseline and a statistically significant improvement from
baseline in visual acuity (ability to read letters on an eye chart).

Following the initial 12-week fixed-dosing phase of the trial, patients
continued to receive therapy at the same dose on a PRN (as needed) dosing
schedule based upon the physician assessment of the need for re-treatment
in accordance with pre-specified criteria. At the 2008 meeting of the
Association for Vision and Ophthalmology (ARVO), it was reported that, on
average, patients on the PRN dosing schedule maintained the gain in visual
acuity and decrease in retinal thickness achieved at week 12 through week
32 of the study.

About VEGF Trap-Eye

Vascular Endothelial Growth Factor (VEGF) is a naturally occurring
protein in the body whose normal role is to trigger the formation of new
blood vessels (angiogenesis) to support the growth of the body’s tissues
and organs. It has also been associated with the abnormal growth and
fragility of new blood vessels in the eye, which lead to the development of
wet AMD. VEGF Trap-Eye is a fully human, soluble VEGF receptor fusion
protein that binds all forms of VEGF-A along with the related placental
growth factor (PIGF) and VEGF-B. VEGF Trap-Eye is a specific and highly
potent blocker of these growth factors. Blockade of VEGF can prevent
abnormal blood vessel formation as well as vascular leak and has proven
beneficial in the treatment of wet AMD.

About Wet AMD

Age-related Macular Degeneration (AMD) is a leading cause of acquired
blindness. Macular degeneration is diagnosed as either dry (non-exudative)
or wet (exudative). In wet AMD, new blood vessels grow beneath the retina
and leak blood and fluid. This leakage causes disruption and dysfunction of
the retina creating blind spots in central vision, and it can account for
blindness in wet AMD patients. Wet AMD is the leading cause of blindness
for people over the age of 65 in the U.S. and Europe.

About Bayer HealthCare

The Bayer Group is a global enterprise with core competencies in the
fields of health care, nutrition and high-tech materials. Bayer HealthCare,
a subsidiary of Bayer AG, is one of the world’s leading, innovative
companies in the healthcare and medical products industry and is based in
Leverkusen, Germany. The company combines the global activities of the
Animal Health, Consumer Care, Diabetes Care and Pharmaceuticals divisions.
The pharmaceuticals business operates under the name Bayer Schering Pharma
AG. Bayer HealthCare’s aim is to discover and manufacture products that
will improve human and animal health worldwide. Find more information at
bayerhealthcare.

Bayer Schering Pharma is a worldwide leading specialty pharmaceutical
company. Its research and business activities are focused on the following
areas: Diagnostic Imaging, General Medicine, Specialty Medicine and Women’s
Healthcare. With innovative products, Bayer Schering Pharma aims for
leading positions in specialized markets worldwide. Using new ideas, Bayer
Schering Pharma aims to make a contribution to medical progress and strives
to improve the quality of life. Find more information at
bayerscheringpharma.de.

About Regeneron

Regeneron is a fully integrated biopharmaceutical company that
discovers, develops, and commercializes medicines for the treatment of
serious medical conditions. In addition to ARCALYST(TM) (rilonacept)
Injection for Subcutaneous Use, its first commercialized product, Regeneron
has therapeutic candidates in clinical trials for the potential treatment
of cancer, eye diseases, and inflammatory diseases, and has preclinical
programs in other diseases and disorders. Additional information about
Regeneron and recent news releases are available on Regeneron’s Web site at
regeneron.

Bayer HealthCare Forward Looking Statement

This release may contain forward-looking statements based on current
assumptions and forecasts made by Bayer Group or subgroup management.
Various known and unknown risks, uncertainties and other factors could lead
to material differences between the actual future results, financial
situation, development or performance of the company and the estimates
given here. These factors include those discussed in Bayer’s public reports
which are available on the Bayer website at bayer. The
company assumes no liability whatsoever to update these forward-looking
statements or to conform them to future events or developments.

Regeneron Forward Looking Statement

This news release discusses historical information and includes
forward-looking statements about Regeneron and its products, development
programs, finances, and business, all of which involve a number of risks
and uncertainties, such as risks associated with preclinical and clinical
development of Regeneron’s drug candidates, determinations by regulatory
and administrative governmental authorities which may delay or restrict
Regeneron’s ability to continue to develop or commercialize its product and
drug candidates, competing drugs that are superior to Regeneron’s product
and drug candidates, uncertainty of market acceptance of Regeneron’s
product and drug candidates, unanticipated expenses, the availability and
cost of capital, the costs of developing, producing, and selling products,
the potential for any collaboration agreement, including Regeneron’s
agreements with the sanofi-aventis Group and Bayer HealthCare, to be
cancelled or to terminate without any product success, risks associated
with third party intellectual property, and other material risks. A more
complete description of these and other material risks can be found in
Regeneron’s filings with the United States Securities and Exchange
Commission (SEC), including its Form 10-Q for the quarter ended March 31,
2008. Regeneron does not undertake any obligation to update publicly any
forward-looking statement, whether as a result of new information, future
events, or otherwise unless required by law.

Bayer HealthCare
bayer

Monthly replacement contact lens wearers notice a decline in lens performance in weeks three and four of wear, a survey reveals. Findings from the research among monthly lens wearers in France, in which 20 different brands of lenses were represented, show a decrease in wearing comfort over the course of a month, with no significant differences between wearers of hydrogel and silicone hydrogel monthly replacement lenses.

About seven in ten monthly silicone hydrogel (71 percent) and hydrogel (68 percent) wearers reported a decrease in wearing comfort as the month progressed. Asked which week of the month, in general, they start to notice that their lenses become more uncomfortable, 95 percent said they become aware of discomfort in weeks three and four. Monthly silicone hydrogel wearers who experienced discomfort tended to notice it earlier in the lens cycle than hydrogel wearers.

“Discomfort and, in particular, dryness-related discomfort is a prime reason that many contact lens wearers either reduce or discontinue wearing their contacts,” says Sheila Hickson-Curran, Director, Medical Affairs, VISTAKON®, Division of Johnson & Johnson Vision Care, Inc. “This study suggests that contact lens wearers should talk to their eye care professional if they are noticing a decline in lens performance over time.”

Discomfort and other eye related problems could also occur for lens wearers who exceed the recommended wear and replacement schedule of a lens, according to Dr. Hickson-Curran.

Even though doctors and manufacturers provide instructions about caring for and wearing contact lenses, less than half of wearers (46 percent) always replace their contact lenses in accordance with their doctor’s recommended schedule, with younger wearers less likely to be compliant according to Americans’ Attitudes & Perceptions About Vision Care, a 2006 survey of 3,700 Americans conducted by Harris Interactive® on behalf of The Vision Care Institute™, LLC, a Johnson & Johnson Company.

“It is quite simple,” Hickson-Curran notes. “If you wear a daily disposable contact lens, put in a fresh new lens every day; a bi-weekly, once every two weeks, and a monthly, once a month. By not following instructions on proper wear and care, contact lens wearers are more likely to experience discomfort and may put themselves at greater risk for infection or other serious complications.”

To help contact lens wearers be compliant, VISTAKON® offers a complimentary online reminder service called ACUMINDER™. Available at acuminder, visitors can elect to receive an automatic reminder about changing or ordering new contact lenses via e-mail, cell phone text message, and/or a computer desktop prompt. A newly launched application for Facebook users (acuminder/facebook) expands its functionality into a multipurpose lifestyle tool that can also send out reminders for just about anything, such as taking daily medications, doctors’ visits, work deadlines, important social events and more.

ACUMINDER™ users self report that they are becoming more compliant thanks to the reminder service, which is open to all contact lens wearers. In its first year, more than 11,000 contact lens wearers signed up for ACUMINDER™. In a January 2008 survey, bi-weekly contact lens wearers reported a marked improvement in their contact lens behavior — the average number of days between lens changes decreased from 19 days to a near-perfect compliance of 15 days.

About the Research

An independent market research company conducted an online survey among consumers in France during October and November 2007. Johnson & Johnson Vision Care, Inc., sponsored the survey although subjects were unaware of the sponsor’s identity. The sample was randomly selected from a consumer database of contact lens wearers designed to be representative of all existing brands in the French market. In total, 20 different brands of lenses were represented. The monthly replacement lens SUREVUE® Brand Contact lenses (not available in the United States) was the only Johnson & Johnson Vision Care product represented, since the company’s ACUVUE® Brand Contact lenses are recommended for daily, weekly, or bi-weekly replacement.

Data was analyzed for a total of 434 existing contact lens wearers who completed the survey. Of these, 271 were wearing monthly replacement hydrogel lenses and 163 wore monthly silicone hydrogel lenses. All wearers were aged from 18-40 years and were frequent contact lens users, wearing their lenses at least three days a week and either all day long or during the day. Lens wearing history (i.e., number of years’ wear) and care regime were not investigated in this survey.

ACUVUE® Brand Contact Lenses are available by prescription only for vision correction. An eye care professional will determine whether contact lenses are right for you. Although rare, serious eye problems can develop while wearing contact lenses. To help avoid these problems, follow the wear and replacement schedule and the lens care instructions provided by your eye doctor. Do not wear contact lenses if you have an eye infection, or experience eye discomfort, excessive tearing, vision changes, redness or other eye problems. If one of these conditions occurs, contact your eye doctor immediately.

ACUVUE® , SUREVUE® ,ACUMINDER™, and VISTAKON® are trademarks of Johnson & Johnson Vision Care, Inc.

Johnson and Johnson
jnj

New research at UAB indicates intraocular lenses (IOL) that block blue light might prove detrimental for older persons in dim lighting conditions or at night.

IOLs are implanted into patients’ eyes following cataract surgery. New blue-light blocking lenses, which are thought by some to help prevent age-related macular degeneration, are gaining in popularity compared to clear IOLs.

“Aging eyes have a decreased sensitivity to light,” said Greg Jackson, Ph.D., UAB assistant professor of ophthalmology. “Yet older eyes absorb more violet or blue light than light of longer wavelengths. IOLs that block blue light may decrease an older person’s ability to see in low light conditions, which could increase their risk for falls or motor vehicle crashes.”

University of Alabama at Birmingham
701 20th St. S., AB 1320
Birmingham, AL 35294-0113
United States
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While baseball fans still rank “The Catch” by Willie Mays in the 1954 World Series as one of the greatest baseball moments of all times, scientists see the feat as more of a puzzle: How does an outfielder get to the right place at the right time to catch a fly ball?

Thousands of fans (and hundreds of thousands of YouTube viewers) saw Mays turn his back on a fly ball, race to the center field fence and catch the ball over his shoulder, seemingly a precise prediction of a fly ball’s path that led his team to victory. According to a recent article in the Journal of Vision (“Catching Flyballs in Virtual Reality: A Critical Test of the Outfielder Problem”), the “outfielder problem” represents the definitive question of visual-motor control. How does the brain use visual information to guide action?

To test three theories that might explain an outfielder’s ability to catch a fly ball, researcher Philip Fink, PhD, from Massey University in New Zealand and Patrick Foo, PhD, from the University of North Carolina at Ashville programmed Brown University’s virtual reality lab, the VENLab, to produce realistic balls and simulate catches. The team then lobbed virtual fly balls to a dozen experienced ball players.

“The three existing theories all predict the same thing: successful catches with very similar behavior,” said Brown researcher William Warren, PhD. “We realized that we could pull them apart by using virtual reality to create physically impossible fly ball trajectories.”

Warren said their results support the idea that the ball players do not necessarily predict a ball’s landing point based on the first part of its flight, a theory described as trajectory prediction. “Rather than predicting the landing point, the fielder might continuously track the visual motion of the ball, letting it lead him to the right place at the right time,” Warren said.

Because the researchers were able to use the virtual reality lab to perturb the balls’ vertical motion in ways that would not happen in reality, they were able to isolate different characteristics of each theory. The subjects tended to adjust their forward-backward movements depending on the perceived elevation angle of the incoming ball, and separately move from side to side to keep the ball at a constant bearing, consistent with the theory of optical acceleration cancellation (OAC). The third theory, linear optical trajectory (LOT), predicted that the outfielder will run in a direction that makes the visual image of the ball appear to travel in a straight line, adjusting both forward-backward and side-to-side movements together.

Fink said these results focus on the visual information a ball player receives, and that future studies could bring in other variables, such as the effect of the batter’s movements or sound.

“As a first step we chose to concentrate on what seemed likely to be the most important factor,” Fink said. “Fielders might also use information such as the batter’s swing or the sound of the bat hitting the ball to help guide their movements.”

Source:
Jessie Williams
Association for Research in Vision and Ophthalmology

What is a cataract?

A cataract is a cloudy or opaque region of the eye’s naturally clear lens. In healthy eyes, light rays pass through the lens and are focused on the retina (positioned in the back of the eye) to produce a clear illustration of what is seen. A cataract forms when the lens is clouded and it becomes difficult for light rays to pass through, resulting in distorted vision.

Who is at high risk?

For most people, cataracts are a natural result of aging. Many who suffer from cataracts are over age 60. Approximately 50 percent of people between ages 65 and 74, and 70 percent of those 75 and older, suffer from cataracts.

Although aging has been reported as the strongest influence of cataract development, other factors may include eye injuries, radiation exposure, excessive exposure to sunlight, and certain metabolic diseases, such as diabetes. Genetics also play a significant role in cataract formation.

Noticeable Symptoms of Cataracts May Include:

— Cloudy, blurry, or foggy vision
— Double vision in one eye
— Loss of eye color
— Frequent prescription changes in eyeglasses
— Poor nighttime vision
— Sensitivity to glare from bright lights or the sun

How are cataracts diagnosed?

Cataracts can be diagnosed through various tests performed by an ophthalmologist. These tests may include the standard ophthalmic exam, which examines the patient’s visual acuity, or the slit lamp examination, which examines the front structure of the eye. Although moderately rare, other tests may also be performed, including the glare test, contrast sensitivity test, potential visual test, and specular microscopic of the cornea.

How are cataracts removed?

There are no known medications, eye drops, glasses or exercises that can cure or prevent cataracts from forming. Surgical removal is the only treatment for removing cataracts; however, surgery may not always be necessary. It is not recommended to remove a cataract if a patient is only experiencing a slight blur in vision.

A simple adjustment to the eyeglass prescription may be a temporary solution. Cataract surgery is considered once the patient is visibly unable to perform everyday activities. The patient and doctor should decide together when surgery is necessary.

How is cataract surgery performed?

Prior to surgery, the patient and doctor discuss options for surgery, and together they decide which type of removal and lens replacement process is best. During surgery, the clouded lens is removed from the eye and replaced with an artificial lens through a small surgical incision. In most cases, the cloudy lens is replaced with a permanent intraocular lens. The surgery can be done in an outpatient facility or hospital. With the escort of a friend of family member, the patient is not required to stay overnight.

Primary prevention

It is highly recommended to avoid sun exposure-a known factor contributing to cataract formation. Wearing protective UV sunglasses helps reduce the amount of exposed light to the eye. If applicable, quitting smoking is also recommended to decrease the risk of cataracts.

Visit our health information library for more educational information on cataracts and available treatments.

Source: American Academy of Ophthalmology

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