Month: April 2014

Advanced Cell Technology, Inc. (OTCBB:ACTC), a biotechnology company applying cellular technology in the field of regenerative medicine, announced that it has received notification from the US Food and Drug Administration (FDA) that the Agency is currently drafting a response to the Company relating to the Investigational New Drug (IND) Application it filed in November seeking clearance to initiate a Phase I/II multicenter study using embryonic stem cell derived retinal cells to treat patients with Stargardt’s Macular Dystrophy (SMD). ACT is currently on clinical hold pending a response from the Agency, which it expects within the next few weeks.

“We look forward to receiving the FDA’s response and working with them to address any questions that they may have,” said William M. Caldwell IV, Advanced Cell’s Chairman and CEO. “Although ACT has taken important steps to advance our RPE program during the last several years, we anticipate the need for further discussions with the Agency before clinical trials can proceed.”

Source
Advanced Cell Technology, Inc.

Akorn, Inc. (NASDAQ:AKRX) a niche generic pharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has granted approval of the Company’s Erythromycin Ophthalmic Ointment USP 1 g as a supplement to the Company’s already approved Abbreviated New Drug Application (ANDA) for Erythromycin Ophthalmic Ointment USP 3.5 g. The company has begun shipping the product to its customers.

“Recent market shortages have made this an attractive product which is complimentary to the other ophthalmic ointments Akorn currently sells. This approval gives us access to both the sizes of Erythromycin Ophthalmic Ointment and positions us to compete effectively in all channels through which the product is sold.”

Raj Rai, Chief Executive Officer of Akorn stated, “Recent market shortages have made this an attractive product which is complimentary to the other ophthalmic ointments Akorn currently sells. This approval gives us access to both the sizes of Erythromycin Ophthalmic Ointment and positions us to compete effectively in all channels through which the product is sold.”

According to IMS Health, the annualized U.S. sales for Erythromycin 1 g based on second quarter 2010 data were approximately $23 million.

Source:

Akorn, Inc.

A study of
ankylosing spondylitis (AS) patients treated with Abbott’s HUMIRA(R) showed
a decrease in the rate of uveitis flares by approximately half compared to
patients treated with placebo. Ankylosing spondylitis is an inflammatory
disease of the spine, and may also be associated with other inflammatory
diseases of the skin, eyes, and intestines. Uveitis, or inflammation of the
eye, occurs in up to 40 percent of people with AS, and can lead to severe
and painful symptoms, including eye damage and blindness. These data were
presented today at the American College of Rheumatology Annual Scientific
Meeting in Boston.

The RHAPSODY (Review of safety and effectiveness witH Adalimumab in
Patients with active ankylosing SpOnDYlitis) trial was designed to examine
the effectiveness of HUMIRA in treating the signs and symptoms of AS in
patients with active disease despite previous standard treatment. The 1,250
patient trial also included a subset of patients (n=274) with uveitis.
Results of the trial suggested that the number of uveitis flares was
reduced in patients with active AS treated with HUMIRA.

In the prospective, multi-national, open-label trial, adult patients
with active AS who had insufficient responses to prior non-steroidal
anti-inflammatory drug (NSAID) therapy received open-label HUMIRA 40 mg
subcutaneously every other week for 12 weeks. Patients with symptomatic
uveitis at baseline and/or in the previous year received the same regimen
for a total of 20 weeks. Evaluations of treatment effects were measured at
weeks 2, 6, 12 and week 20, if applicable.

This analysis measured the number of acute flares during treatment with
HUMIRA both for all patients in the trial and for patients with pre-known
history of uveitis. The rate was calculated as flares per 100-patient-years
(100-PYs), which represent the number of flares that would occur in 100
patients observed or treated for one year. The rate of uveitis flares was
reduced by approximately half during treatment with HUMIRA compared with
the rate prior to the trial (15 flares/100-PY to 7.4 flares/100-PY in the
entire trial population, 68.4 flares/100-PY to 28.9 flares/100-PY in the
subset with a history of uveitis).

Overall, 27 adverse events of uveitis were reported for 25/1,250
patients. Two of the 25 patients experienced an attack of uveitis for the
first time. In both patients, the general AS disease activity was high at
time of the anterior uveitis episode.

“Uveitis is a fairly common and potentially serious complication of
ankylosing spondylitis,” said Martin Rudwaleit, M.D., of the Charite
University Hospital in Germany and lead author of the trial. “This study is
an example of the research needed to better understand this condition and
the impact it has on these patients.”

About RHAPSODY

RHAPSODY (Review of safety and effectiveness witH Adalimumab in
Patients with active ankylosing SpOnDYlitis) is a prospective,
multi-national, open-label trial designed to examine the effectiveness of
HUMIRA in treating the signs and symptoms of the disease in a large number
of patients (n=1,250) with active AS despite previous standard treatment,
including patients with uveitis (n=274), in real-life clinical practices.

About Uveitis

There are three different types of uveitis based on the part of the eye
involved, including anterior, posterior or intermediate. Acute anterior
uveitis occurs in up to 40 percent of patients with AS. Symptoms include
pain, light sensitivity, blurry vision or reduced vision; severe
complications may include high eye pressure, cataracts, or glaucoma, which
can lead to permanent loss of vision.

About Ankylosing Spondylitis

Ankylosing spondylitis (AS) is a type of arthritis that primarily
causes inflammation of the spine. Ankylosing means “stiff or rigid” and
spondylitis means “inflammation of the spine.” Advanced AS can lead to new
bone formation on the spine causing the spine to fuse in a fixed position.
Typically, the first symptoms of AS are gradual and can include frequent
pain and stiffness in the lower back and buttocks. In addition to back
pain, other symptoms can include inflammation of joints or tendons, weight
loss, fatigue, and eye inflammation (uveitis).

AS affects an estimated 129 out of 100,000 people in the United States
and commonly develops between the ages of 15 and 40. Men are three times
more likely than women to develop AS. Although the course and severity of
AS varies from person to person, some patients with progressive AS can
develop spinal deformities leading to significant disability.

The cause of AS is not known, though genetics may play a role: 90
percent of people with AS share a common genetic marker, but having this
genetic marker does not mean a person will develop the disease.

Important Safety Information

Serious infections, sepsis, tuberculosis (TB) and opportunistic
infections, including fatalities, have been reported with the use of
TNF-blocking agents, including HUMIRA. Many of these serious infections
have occurred in patients also taking other immunosuppressive agents that
in addition to their underlying disease could predispose them to
infections. Infections have also been reported in patients receiving HUMIRA
alone. Treatment with HUMIRA should not be initiated in patients with
active infections. TNF-blocking agents, including HUMIRA, have been
associated with reactivation of hepatitis B (HBV) in patients who are
chronic carriers of this virus. Some cases have been fatal. Patients at
risk for HBV infections should be evaluated for prior evidence of HBV
infections before initiating HUMIRA. The combination of HUMIRA and anakinra
is not recommended and patients using HUMIRA should not receive live
vaccines.

More cases of malignancies have been observed among patients receiving
TNF blockers, including HUMIRA, compared to control patients in clinical
trials. These malignancies, other than lymphoma and non-melanoma skin
cancer, were similar in type and number to what would be expected in the
general population. There was an approximately 3.5 fold higher rate of
lymphoma in combined controlled and uncontrolled open-label portions of
HUMIRA clinical trials. The potential role of TNF-blocking therapy in the
development of malignancies is not known. TNF-blocking agents, including
HUMIRA, have been associated in rare cases with demyelinating disease and
severe allergic reactions. Infrequent reports of serious blood disorders
have been reported with TNF-blocking agents.

Worsening congestive heart failure (CHF) has been observed with
TNF-blocking agents, including HUMIRA, and new onset CHF has been reported
with TNF-blocking agents. Treatment with HUMIRA may result in the formation
of autoantibodies and rarely, in development of a lupus-like syndrome.

The most frequent adverse events seen in the placebo-controlled
clinical trials in adults with rheumatoid arthritis (HUMIRA vs. placebo)
were injection site reactions (20 percent vs. 14 percent), upper
respiratory infection (17 percent vs. 13 percent), injection site pain (12
percent vs. 12 percent), headache (12 percent vs. 8 percent), rash (12
percent vs. 6 percent) and sinusitis (11 percent vs. 9 percent).
Discontinuations due to adverse events were 7 percent for HUMIRA and 4
percent for placebo. As with any treatment program, the benefits and risks
of HUMIRA should be carefully considered before initiating therapy.

In HUMIRA clinical trials for ankylosing spondylitis, psoriatic
arthritis and Crohn’s disease, the safety profile for adult patients
treated with HUMIRA was similar to the safety profile seen in adult
patients with rheumatoid arthritis.

About HUMIRA

HUMIRA is approved for the treatment of adults with rheumatoid
arthritis, psoriatic arthritis (PsA), ankylosing spondylitis (AS) and
Crohn’s disease in the United States and in Europe. HUMIRA resembles
antibodies normally found in the body. It works by blocking tumor necrosis
factor alpha (TNF-alpha), an inflammatory protein that, when produced in
excess, plays a key role in the inflammatory responses of autoimmune
diseases.

Earlier this year, HUMIRA received FDA approval of data in the Clinical
section of the label regarding the long-term maintenance of efficacy to 5
years with respect to clinical response, physical function and radiographic
response in patients with rheumatoid arthritis. To date, HUMIRA has been
approved in 67 countries and more than 190,000 people worldwide are
currently being treated with HUMIRA. Clinical trials are currently under
way evaluating the potential of HUMIRA in other immune-mediated diseases.

In the U.S., HUMIRA is approved by the FDA for reducing signs and
symptoms, inducing major clinical response, inhibiting the progression of
structural damage, and improving physical function in adult patients with
moderately to severely active RA. HUMIRA is indicated for reducing the
signs and symptoms of active arthritis, inhibiting the progression of
structural damage and improving physical function in patients with
psoriatic arthritis. HUMIRA can be used alone or in combination with
methotrexate or other disease-modifying anti-rheumatic drugs (DMARDs).
HUMIRA is also approved for reducing signs and symptoms in patients with
active AS.

Earlier this year, HUMIRA was approved for reducing the signs and
symptoms and inducing and maintaining clinical remission in adults with
moderately to severely active Crohn’s disease who have had an inadequate
response to conventional therapy, and reducing the signs and symptoms and
inducing clinical remission in these patients if they have also lost
response to or are intolerant to infliximab.

Abbott’s Commitment to Immunology

Abbott is focused on the discovery and development of innovative
treatments for immunologic diseases. The Abbott Bioresearch Center, founded
in 1989 in Worcester, Mass., United States, is a world-class discovery and
basic research facility supporting research and development of biologic
treatments. Abbott Biotechnology Limited, which opened April 10, 2007, in
Barceloneta, Puerto Rico, is the main production facility for HUMIRA.

About Abbott

Abbott (NYSE: ABT) is a global, broad-based health care company devoted
to the discovery, development, manufacture and marketing of pharmaceuticals
and medical products, including nutritionals and devices. The company
employs 65,000 people and markets its products in more than 130 countries.

Abbott’s news releases and other information are available on the
company’s Web site at abbott.

Abbott
abbott

View drug information on Humira.

Bayer HealthCare AG and Regeneron Pharmaceuticals, Inc. (Nasdaq: REGN) announced that VEGF Trap-Eye showed positive results in a Phase II study in patients with Diabetic Macular Edema (DME). The primary endpoint of the study, a statistically significant improvement in visual acuity over 24 weeks compared to the standard of care in DME, macular laser treatment, was met. Visual acuity improvement was measured by the mean number of letters gained over the initial 24 weeks of the study.

“The ability of VEGF Trap-Eye to significantly improve vision in patients with DME in this initial Phase II study is encouraging,” said Kemal Malik, MD, Head of Global Development and member of the Bayer HealthCare Executive Committee. “Bayer and Regeneron will discuss the next steps in further developing VEGF Trap-Eye in this indication.”

“The magnitude of the gain in visual acuity achieved with VEGF Trap-Eye in this Phase II study demonstrates the biologic activity of VEGF Trap-Eye in treating diabetic macular edema, a disease in which high levels of vascular endothelial growth factor (VEGF) are present,” said Diana Do, MD, the Principal Investigator for the study and Assistant Professor of Ophthalmology and Assistant Head of the Retina Fellowship Training Program at the Wilmer Eye Institute, The Johns Hopkins University School of Medicine in Baltimore, Maryland.

Patients in each of the four dosing groups receiving VEGF Trap-Eye achieved statistically significantly greater mean improvements in visual acuity (8.5 to 11.4 letters of vision gained) compared to patients receiving laser therapy (2.5 letters gained) at week 24 (p< 0.01 for each VEGF Trap-Eye group versus laser). VEGF Trap-Eye was generally well tolerated, and there were no drug-related serious adverse events. A full analysis of the primary endpoint results of the Phase II study will be presented at the Angiogenesis 2010 Clinical Trials meeting on February 20, 2010 in Miami, Florida. About the Phase II study In this double-masked, prospective, randomized, multi-center Phase II trial, entitled DA VINCI (DME And VEGF Trap-Eye: INvestigation of Clinical Impact), 219 patients with clinically significant DME with central macular involvement were randomized to five groups. The control group received macular laser treatment at week one and patients were eligible for repeat laser treatments, but no more frequently than at 16 week intervals. Two groups received monthly doses of 0.5 or 2.0 milligrams (mg) of VEGF Trap-Eye throughout the 6-month dosing period. Two groups received three initial monthly doses of 2.0 mg of VEGF Trap-Eye (at baseline and weeks 4 and 8), followed through week 24 by either every 8-week dosing or as-needed (PRN) dosing with specific repeat dosing criteria. The following summarizes the mean gain in visual acuity at week 24 by dosing arm and the mean number of treatments received by patients over the first six monthly visits: — Standard-of-care macular laser treatment (n=44; 1.7 treatments): +2.5 letters gained — VEGF Trap-Eye 0.5 mg monthly (n=44; 5.6 injections): +8.6 letters gained — VEGF Trap-Eye 2 mg monthly (n=44; 5.5 injections): +11.4 letters gained — VEGF Trap-Eye 2 mg every other month, following 3 monthly injections (n=42; 3.8 injections): +8.5 letters gained — VEGF Trap-Eye 2 mg as-needed, following 3 monthly injections (n=45; 4.4 injections): +10.3 letters gained The study was not designed to evaluate statistical differences among the results achieved in each of the VEGF Trap-Eye groups and no significant differences were observed. Over 90 percent of the VEGF Trap-Eye patients and the control patients remained in the study at the 6-month primary endpoint evaluation. VEGF Trap-Eye was generally well-tolerated and there were no ocular or non-ocular drug-related serious adverse events reported in the study. The adverse events reported were those typically associated with intravitreal injections or the underlying disease. The most frequent adverse events reported among the patients receiving VEGF Trap-Eye included conjunctival hemorrhage, eye pain, floaters (myodesopsia), ocular redness (hyperemia), and increased intraocular pressure. There were three deaths among the 175 patients treated with VEGF Trap-Eye and none in the 44 patients treated with laser over 6 months. All three patients had underlying risk factors for their cause of death and the cases were not reported to be drug-related. Following the initial 24 weeks of treatment, patients continue to be treated for another 24 weeks on the same dosing regimens. Initial one-year results will be available later this year. Regeneron and Bayer HealthCare are sponsors of the DA VINCI study. About Diabetic Macular Edema (DME) Diabetic Macular Edema is the most prevalent cause of moderate vision loss in patients with diabetes. DME is a common complication of Diabetic Retinopathy, a disease affecting the blood vessels of the retina. Clinically significant DME is a leading cause of blindness in younger adults (under 50). Clinically significant DME occurs when fluid leaks into the center of the macula, the light-sensitive part of the retina responsible for sharp, direct vision. Fluid in the macula can cause severe vision loss or blindness. Approximately 370,000 Americans currently suffer from clinically significant DME, with 95,000 new cases arising each year. According to the American Diabetes Association, more than 18 million Americans currently suffer from diabetes and many other people are at risk for developing diabetes. With the incidence of diabetes steadily climbing, it is projected that up to 10 percent of all patients with diabetes will develop DME during their lifetime. About VEGF Trap-Eye 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 (PlGF). VEGF Trap-Eye is a specific and highly potent blocker of these growth factors. VEGF Trap-Eye is currently in Phase III development in wet (age-related) macular degeneration (AMD). The VIEW 1 (VEGF Trap-Eye: Investigation of Efficacy and Safety in Wet AMD) study is being conducted in the United States and Canada by Regeneron and the VIEW 2 study is being conducted in Europe, Asia Pacific, Japan, and Latin America by Bayer HealthCare. The primary endpoint of these non-inferiority studies is the proportion of patients treated with VEGF Trap-Eye who maintain vision at the end of one year, compared to ranibizumab patients. Patient enrollment has been completed in both studies with initial year-one primary endpoint data expected in the second half of 2010. VEGF Trap-Eye is also in Phase III development for the treatment of Central Retinal Vein Occlusion (CRVO), another major cause of blindness. The COPERNICUS (COntrolled Phase III Evaluation of Repeated iNtravitreal administration of VEGF Trap-Eye In Central retinal vein occlusion: Utility and Safety) study is being led by Regeneron and the GALILEO (General Assessment Limiting InfiLtration of Exudates in central retinal vein Occlusion with VEGF Trap-Eye) study is being led by Bayer HealthCare. The primary endpoint of both studies is improvement in visual acuity versus baseline after six months of treatment. Initial data from the CRVO program are anticipated in early 2011. About Regeneron Pharmaceuticals, Inc. Regeneron is a fully integrated biopharmaceutical company that discovers, develops, and commercializes medicines for the treatment of serious medical conditions. In addition to ARCALYST® (rilonacept) Injection for Subcutaneous Use, its first commercialized product, Regeneron has therapeutic candidates in Phase III clinical trials for the potential treatment of cancer, eye diseases, and gout. Additional therapeutic candidates are in earlier stage development programs in rheumatoid arthritis and other inflammatory conditions, pain, cholesterol reduction, allergic conditions, and cancer. 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, Bayer Schering Pharma, Consumer Care and Medical Care divisions. Bayer HealthCare’s aim is to discover and manufacture products that will improve human and animal health worldwide. About Bayer Schering Pharma 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. Bayer HealthCare Forward-Looking Statements 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 www.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 canceled 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-K for the year ended December 31, 2008 and Form 10-Q for the quarter ending September 30, 2009. 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. Source: Bayer

H. Dunbar Hoskins Jr., MD, will be the recipient of the 2009 Catalyst Award, the highest honor bestowed by the Glaucoma Research Foundation (GRF) acknowledging exemplary leadership in sustaining innovative research and education.

The Award will be presented as the centerpiece of GRF’s 31st Anniversary benefit celebration to be held Wednesday, January 28, 2009 at the Westin St. Francis Hotel in San Francisco. The announcement was made to guests at the Glaucoma Research Foundation’s (GRF) Annual Dinner following GRF’s Annual Meeting today.

“Dr. Hoskins has earned The Catalyst Award several times over,” said GRF President and CEO Thomas M. Brunner. “While in private practice, there was his visionary leadership as co-founder of GRF and the thoughtful guidance he provided during those all-important formative early years, along with co-founders Robert Shaffer, MD (1912-2007), and John Hetherington, MD. Certainly he is the personification of ‘catalyst’. And then, since January 1, 1993, there has also been his widely praised leadership as Executive Vice President of the American Academy of Ophthalmology.”

Previous recipients of The Catalyst Award have included Steven and Michele Kirsch, (whose contributions co-founding GRF’s Catalyst For a Cure – CFC – research consortium actually inspired the award itself); Allergan Chairman, President and CEO David E. I. Pyott (acknowledging Allergan’s long standing and unrivaled support of GRF’s mission); GRF board member F.T. Barr (whose Barr Foundation in Houston, TX, provided the cornerstone funding for the just completed CFC campaign, and now anchors the next phase of the CFC); and Alcon Chairman, President and CEO Cary Rayment (and Alcon’s particular commitment to innovative research).

The theme of the 31st Anniversary benefit – building on the traditional event title “Speeding the Cure. Spreading the Word – will be ‘Honoring the Physicians’,” Brunner reported. “Dr. Hoskins is the embodiment of the qualities we see reflected in so many of the gifted physicians dedicated to serving those with glaucoma.”

An internationally recognized glaucoma specialist, having authored or co-authored more than 70 publications and presented more than 300 invited lectures, Dr. Hoskins is a Clinical Professor of Ophthalmology at the University of California School of Medicine, San Francisco. He has received numerous awards and honors including the Academy’s Lifetime Achievement Award in 2003 and the A. Edward Maumenee award of the Pan American Association of Ophthalmology. He has held numerous other positions in ophthalmology, medicine and business. Among the highlights: Chairman of St. Mary’s Hospital and Medical Center San Francisco, Chairman of Mercy Services Corporation, founder and Chairman of Medem Corporation, Founding Director of the American Glaucoma Society, and Secretary-Treasurer of the Pan American Association of Ophthalmology, the American Eye Study Club and the American Glaucoma Society. He is a member of the International Council of Ophthalmology.

About the Glaucoma Research Foundation

Founded in 1978 and based in San Francisco, the Glaucoma Research Foundation is the nation’s most experienced foundation dedicated solely to glaucoma research and education.

Research programs include the precedent-setting Catalyst For a Cure consortium bringing together neuroscience and genetics laboratories from Johns Hopkins University, University of Utah, University of Washington, and Vanderbilt, to work in real time collaboration to speed the pace of discovery for a cure.

Education and outreach programs include the website glaucoma, the number one internet search choice for “glaucoma” and a national model of internet accessibility for the vision impaired, publications like Understanding and Living with Glaucoma, and its newsletter Gleams distributed at no cost three times a year to more than 75,000 households nationally.

Glaucoma Research Foundation

University of Pittsburgh researchers have discovered a gene linked to age-related maculopathy (ARM), the leading cause of untreatable blindness in the elderly. Their discovery suggests a simple test might be able to identify those at risk for what is commonly known as macular degeneration (AMD) and may lead to the development of more effective preventive strategies.

Researchers report that variations of a gene called PLEKHA1 are strongly associated with a person’s risk of developing ARM. The results, a culmination of 15 years of research, will be published in the September issue of the American Journal of Human Genetics and are currently available online.

The discovery of the gene came about through the team’s efforts to map the genes of 612 families affected by ARM and an additional 323 individuals without a history of macular degeneration. Pooling data from a number of gene mapping studies, researchers were able to identify multiple locations on the chromosomes where there are common gene variants among people with ARM. Specifically, researchers found that a region on one of these chromosomes, chromosome 10, was the one most likely to contain a major gene that influences the risk of ARM. Further analysis of chromosome 10 found that a variation in PLEKHA1 to be strongly associated with a person’s risk of developing ARM.

Earlier this year, researchers from Rockefeller University, Yale University, The National Eye Institute, Duke University, Vanderbilt University, University of Texas Southwestern, and Boston University used similar methods to identify the first gene variant thought to be a major contributor to ARM, complement factor H (CFH) on chromosome 1. The Pittsburgh study confirms involvement of this gene and, for the first time, shows that the association results also accounted for findings from previous genetic studies of AMD families. Importantly, the new study found that having both CFH and PLEKHA1 indicate a greater risk for macular degeneration.

“CFH was the first piece of the puzzle,” said Michael Gorin, M.D., Ph.D., professor of ophthalmology, University of Pittsburgh School of Medicine, and professor of human genetics, University of Pittsburgh Graduate School of Public Health. “To fully understand the pathology of macular degeneration, we knew we needed to expand our investigation to find all of the genes that play a part in this condition. PLEKHA1 is an important second piece, and we’ll keep searching for the rest of the pieces until we get this solved.”

By identifying a number of genetic variants for ARM, researchers hope to use this information to develop a simple set of DNA tests to identify individuals who are at increased risk of this sight-robbing condition. Additionally, they hope to develop new preventive strategies and a better understanding of how ARM occurs.
An important clue to understanding the cause and mechanism of ARM was revealed through this discovery. PLEKHA1, like CFH, is involved in the cellular processes related to inflammation, which supports the hypothesis that damage caused by ARM is, in part, due to inflammation.

ARM is the leading cause of untreatable blindness in the elderly and despite recent advances in the treatment of some forms of this condition, it continues to be a serious threat to vision with no known cure. An estimated 200,000 Americans develop a severe form of AMD each year, making it the leading cause of blindness in people aged 65 and older. As many as 30 percent of individuals over the age of 75 have evidence of macular degenerative changes.

In addition to Dr. Gorin, contributing authors to this study are Johanna Jakobsdottir, graduate student in the department of biostatistics, Graduate School of Public Health (GSPH); Tammy Mah, department of ophthalmology, School of Medicine; Daniel Weeks, Ph.D., professor in the departments of human genetics and biostatistics, GSPH; Robert Ferrell, Ph.D., professor in the department of human genetics, GSPH; and Yvette Conley, Ph.D., assistant professor in the department of health promotion and development, School of Nursing, and assistant professor in the department of human genetics, GSPH.

The research was supported by a grant from the National Eye Institute of the National Institutes of Health, as well as by funds from Research to Prevent Blindness, The Eye & Ear Foundation of Pittsburgh and the Ruth and Milton Steinbach Foundation.

Jocelyn Uhl
UhlJHupmc.edu
phone: 412-647-3555
fax: 412-624-3184

Lisa Rossi
Rossilupmc.edu
phone: 412-647-3555
fax: 412-624-3184

University of Pittsburgh Medical Center
upmc.edu

Genentech, Inc. announced today that the Phase III study BRAVO showed Lucentis® (ranibizumab injection) improved vision, as measured by the primary endpoint of mean change from baseline in best-corrected visual acuity at six months, in patients with macular edema due to branch retinal vein occlusion. The safety profile of Lucentis was consistent with previous experience and no new adverse events related to Lucentis were observed in the study. Retinal vein occlusion (RVO) is a common cause of vision loss that occurs when blood flow through a retinal vein becomes blocked, such as by a blood clot.

BRAVO evaluated the safety and efficacy of six monthly injections of Lucentis compared to monthly sham injections. The two doses of Lucentis studied showed a statistically significant improvement in best-corrected visual acuity (the best vision a person can achieve with an eyeglass or contact lens prescription) at six months compared to sham. Full results will be presented at the Retina Congress, September 30 to October 4, 2009, in New York.

“RVO is a devastating disease and there are no FDA-approved medicines shown to improve vision for six months,” said Hal Barron, M.D., executive vice president, Global Development and chief medical officer, Genentech. “We are excited that another pivotal study has demonstrated the important role Lucentis can play in improving vision in people with difficult-to-treat eye disease, and look forward to the results of CRUISE, a Phase III trial in central-RVO in the third quarter of this year.”

About RVO

RVO occurs when blood flow through a retinal vein becomes blocked, causing swelling (macular edema) and hemorrhages in the retina, which may result in vision loss. Sudden blurring or vision loss in all or part of one eye is common with RVO. RVO can affect people across a wide range of ages, from young, working-aged adults to the elderly.

There are two main types of RVO: branch-RVO, which affects an estimated 684,000 people, and central-RVO, which affects an estimated 211,000 people in the United States.1 Branch-RVO occurs when one of the branches of the main vein of the eye becomes blocked. Central-RVO occurs when the main vein of the eye, located at the optic nerve, becomes blocked.

About BRAVO (FVF4165g)

BRAVO is a multicenter, randomized, double-masked, sham injection-controlled Phase III study, designed to assess the safety and efficacy of Lucentis in treating macular edema secondary to branch-RVO. Patients (n=397) were enrolled at 93 clinical trial sites across the United States.

The 12-month study consists of a six-month, sham-controlled treatment period, followed by a six-month observation period (during which all participants were eligible to receive Lucentis as needed). During the first six-month period, participants received monthly injections of one of two different doses (0.3 mg or 0.5 mg) of Lucentis (n=265) or monthly sham injections (n=132). The study was not designed to compare the two doses of Lucentis. Rescue laser treatment was available starting at month three to all patients meeting pre-specified criteria. The primary endpoint was the mean change from baseline in best-corrected visual acuity score at six months compared to sham.

About Lucentis

Lucentis is a vascular endothelial growth factor (VEGF) inhibitor approved by the U.S. Food and Drug Administration (FDA) for the treatment of neovascular (wet) age-related macular degeneration (AMD). Lucentis is the only FDA-approved treatment for wet AMD proven to improve or maintain vision. In wet AMD clinical trials, Lucentis administered monthly demonstrated an improvement in vision of three lines or more on the study eye chart in up to 41 percent of patients at two years. Nearly all patients (90 percent) in those trials treated monthly with Lucentis maintained vision.

Lucentis is designed to bind to and inhibit VEGF-A, a protein that is believed to play a critical role in the formation of new blood vessels (angiogenesis) and the hyperpermeability (leakiness) of the vessels. In RVO, angiogenesis and hyperpermeability can lead to macular edema, the swelling and thickening of the macula, which is the portion of the eye responsible for fine, detailed central vision.

Lucentis is a prescription medication given by injection into the eye. Lucentis has been associated with detached retina and serious eye infection and should not be used in patients who have an infection in or around the eye. Increases in eye pressure have been seen within one hour of an injection. Although uncommon, conditions associated with eye- and non-eye-related blood clots (arterial thromboembolic events) may occur. Serious side effects included inflammation inside the eye and, rarely, effects related to the injection procedure such as cataract. The most common non-eye-related side effects were nose and throat infection, headache, and respiratory and urinary tract infections. The most common eye-related side effects were the feeling that something is in a patient’s eye, and increased tears. If a patient’s eye becomes red, sensitive to light, painful, or has a change in vision, they should seek immediate care from their eye doctor.

About Genentech

Founded more than 30 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. The company, a wholly-owned member of the Roche Group, has headquarters in South San Francisco, California.

Source: Genetech

View drug information on Lucentis.

For most, the countdown on New
Year’s Eve is a raucously good time. For others, it is the final few
seconds of healthy eyesight.

Incorrect popping of champagne corks is one of the most common
holiday-related eye hazards, according to the American Academy of
Ophthalmology, the Eye M.D. Association.

“It’s a sobering thought, but many revelers forget that popping the
cork on a bottle of champagne is a dangerous activity if done incorrectly,”
said Andrew Iwach, M.D., Academy spokesperson. “Every year, warm bottles of
champagne, coupled with bad cork-removal technique, are responsible for
causing serious, blinding injuries.”

Healthy bottle opening tips include:

— Be aware that a recently shaken bottle increases the risk of eye
injury.

— Make sure sparkling wine is chilled to at least 45 degrees
Fahrenheit before opening. The cork of a warm bottle is more likely to pop
unexpectedly.

— Hold down the cork with the palm of your hand while removing the
wire hood. Point the bottle away from yourself and others at a 45-degree
angle.

— Place a towel over the entire top and grasp the cork, slowly and
firmly twisting it to break the seal.

— Keep the bottle at a 45-degree angle, hold it firmly with one hand
and use the other hand to slowly turn the cork with a slight upward pull.
Continue until the cork is almost out of the neck. Counter the force of the
cork using slight downward pressure just as the cork breaks free from the
bottle.

“By following a few simple safety tips, you can make sure your holidays
are festive and injury free,” said Dr. Iwach.

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.

American Academy of Ophthalmology
aao

Hopkins researchers have found that patients experiencing vision problems following cataract removal and intraocular lens
implantation (CE-IOL) may have better results from laser refractive surgery, which spares them potential complications of
lens implant replacement and the inconvenience of glasses.

“Our study shows that laser refractive surgery is a safe, effective, and predictable way to correct residual refractive
errors such as myopia, hyperopia and astigmatism and is a non-invasive alternative to intraocular surgery and its potential
complications,” says Irene C. Kuo, M.D., assistant professor of ophthalmology at the Wilmer Eye Institute and lead author.

The researchers examined 10 patients, 75 to 81 years of age, who needed glasses or contact lenses following their CE-IOL
procedure and who underwent refractive laser surgery. Following them from one to 38 months, the physicians measured patient
satisfaction, visual acuity and the length of time between CE-IOL and laser refractive surgery.

Kuo said that although all patients expressed satisfaction after laser refractive surgery and the median uncorrected visual
acuity increased from 20/400 to 20/30, final uncorrected visual acuity was not as high as in general laser refractive surgery
patients who did not have implants.

“The patients in our study were older than the average refractive surgery patient by approximately 30 years. Ultimately, our
results support other studies that have found that refractive surgery in older patients is not as predictable as in younger
patients. Additional research looking at how age affects corneal wound healing is important,” said Kuo.

Tips from the American Society of Cataract & Refractive Surgery Meeting

Johns Hopkins Medical Institutions
901 S. Bond St., Ste 550
Baltimore, MD 21231
United States
Phone 410-955-4288
Fax 410-955-4452
hopkinsmedicine/Press_releases

Sean Peterson was looking forward to spending some time with his friends playing paintball one spring weekend. As a former college basketball player, Sean enjoys sports, and paintball seemed like a fun opportunity to employ some of his athletic skills. But what started out as an enjoyable outing eventually turned into a medical emergency. Sean moved his protective mask briefly, and in that brief interval, a paintball hit him in his left eye.

“After the hit, all I could see was a green blur,” Sean recalls. “I went to the emergency room, where I was told that I would probably be blind in my left eye.” Fortunately, after multiple surgeries, Sean has nearly regained his 20/20 vision, but not without some lingering effects from the injury. “I’m still very sensitive to light and I can’t read up close out of my left eye,” said Sean, who still continues to play sports but has not played paintball since.

April is Sports Eye Safety Awareness Month, and the American Academy of Ophthalmology reminds the public that 40,000 people suffer from eye injuries related to sports every year. The Academy advocates the need for athletes to wear appropriate, sport-specific protective eyewear properly fitted by an eye care professional. Lenses made from polycarbonate materials provide the highest level of impact protection; they can withstand a ball or other projectile traveling at 90 miles per hour.

“It’s absolutely necessary for athletes to use protective eyewear because eye injuries can be devastating,” said Dr. Ruth Williams, glaucoma specialist at the Wheaton, IL, Eye Clinic, clinical correspondent for the Academy and Sean Peterson’s doctor. “Unfortunately, many athletes feel they don’t need protective eyewear or that injuries are uncommon. The truth is, many athletes are not as lucky as Sean.”

In addition to abrasions of the cornea and bruises of the lids, sports injuries can include retinal detachments and internal bleeding. The most serious risks involve permanent vision loss along with infection. In addition, patients who have sustained eye injuries are at greater risk for developing glaucoma.

Many sports create risk for eye injuries; however, protection is available for most sports, including basketball, baseball, hockey, football, lacrosse, fencing, paintball, water polo, golf and many others. “Wearing properly fitted protective eyewear will not harm your performance in a game, and it may well save your sight,” says Dr. Williams.

Most sporting leagues don’t require children to wear eye protection, so parents should take special care to ensure their children wear eye protection. “Parents can spare their children needless injury and pain by having them wear protective eyewear,” says Dr. Williams.

In the event of an eye injury, it is important to seek medical help immediately. Even a seemingly light blow can cause a serious eye injury. If a black eye, pain or visual problem occurs after a blow, contact your Eye M.D. or seek emergency medical help at once.

Learn about eye diseases, your risk factors and the names of eye M.D.s in your area by visiting GetEyeSmart.

About the American Academy of Ophthalmology

The American Academy of Ophthalmology 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.

American Academy of Ophthalmology