Month: May 2013

FDA this week is expected to approve Genentech’s Lucentis for the treatment of wet age-related macular degeneration, but the approval will “pose a conundrum” for physicians, patients and insurers because the treatment is expected to cost 10 to 100 times more than a similar Genentech product that also can treat the condition and is already on the market, the New York Times reports. The older drug, Avastin, is approved to treat cancer, but some doctors since late 2005 have been using the injectable medication to treat wet macular degeneration. Avastin costs about $50,000 per year to treat cancer, but because the amount needed for eye injections is small, the cost for treating wet macular degeneration is about $1,000 or less per year. Lucentis is expected to cost at least $10,000 per year. According to the Times, “Genentech has no interest in getting Avastin approved for macular degeneration, because that would undermine the sales of Lucentis, which some analysts predict will have annual sales of several hundred million dollars” (Pollack, New York Times, 6/29). The drugs share some components, and both were designed to block vascular endothelial growth factor — a molecular signal Genentech discovered in 1989 — which controls abnormal blood vessel growth. Lucentis was designed to be a smaller drug that more effectively penetrates the eye and concentrates its effects, minimizing side effects, according to Susan Desmond-Hellmann, president of product development at Genentech (Tansey, San Francisco Chronicle, 6/29).

Concerns
“Use of Avastin instead of Lucentis could save patients and insurers hundreds of millions of dollars a year,” and it is unclear whether they will consider the new treatment “worth” the price, according to the Times. However, many specialists already plan to switch to Lucentis after it is approved because, unlike Avastin, there are clinical trials to support the drug’s safety and efficacy as a treatment for macular degeneration, the Times reports (New York Times, 6/29). In addition, Avastin has a risk of serious side effects, including heart failure, high blood pressure, kidney problems and stroke. Some doctors — including Philip Rosenfeld, an associate professor of ophthalmology at the University of Miami and one of the first doctors to use Avastin for macular degeneration — say the risk of serious side effects from Avastin is much lower when used in small doses in the eye than in the large doses needed to treat cancer. Rosenfeld and a group of doctors hope to conduct their own study to prove the safety and efficacy of the treatment. Rosenfeld said they hope to obtain funding from NIH for the research.

Comments
Desmond-Hellmann said Lucentis is superior to Avastin for treating macular degeneration because it was designed specifically to target the eye. In addition, she said, Lucentis clears out of the body within days, while Avastin remains in the body for weeks (San Francisco Chronicle, 6/29). Desmond-Hellmann said Lucentis would save the health care system money by preventing blindness, which can lead to other injuries and the need for nursing home care. Rosenfeld said, “The whole experience really opens your eyes to how our whole health care system is operating,” adding, “We could be incentivized to use the most effective therapy at the most reasonable cost. But that’s not how our system is set up” (New York Times, 6/29).

“Reprinted with permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

View drug information on Avastin; Lucentis.

Glaucoma – often called “the sneak thief of sight” because it can strike without pain or other symptoms – is one of the leading causes of blindness in the United States. Unfortunately, the vast majority of Americans – 91 percent – incorrectly believe glaucoma is preventable, according to the newest survey by the American Optometric Association (AOA). Although glaucoma is not preventable, if diagnosed and treated early, doctors of optometry can help a patient control the disease. Medication or surgery can slow or prevent further vision loss.

Approximately 2.2 million Americans age 40 and older have glaucoma, according to National Glaucoma Research; of these, as many as 120,000 are blind because of the disease. The number of Americans with glaucoma is estimated to increase to 3.3 million by the year 2020, as baby boomers age.

According to the AOA, glaucoma is a group of eye disorders that occur when internal pressure in the eye increases enough to cause damage to the optic nerve, leading to loss of nerve tissue, resulting in vision loss. The AOA’s annual Eye-Q® survey, which identifies attitudes and behaviors of Americans regarding eye care and related issues, showed that a large number of consumers do not know what glaucoma is and how severe the effects of the disease can be. Ninety-five percent of respondents did not know that glaucoma damages the optic nerve, and only 21 percent of respondents were aware that glaucoma causes deterioration of peripheral or side vision.

According to the AOA, there are two types of glaucoma. The most common type, primary open-angle glaucoma, develops gradually and painlessly, usually without symptoms. A rarer type, acute angle-closure glaucoma, occurs rapidly, and its symptoms may include blurred vision, loss of peripheral vision, seeing colored rings around lights, and pain or redness in the eyes.

“As glaucoma progresses, a person may notice their side vision gradually failing,” said Kerry Beebe, O.D., Chair of AOA’s Clinical Care Group Executive Committee. “When glaucoma remains untreated, people may miss seeing objects to the side and out of the corner of their eye. Without treatment, people with glaucoma will continue to slowly lose their peripheral vision, and eventually their central vision as well. And vision lost to glaucoma cannot be recovered, so early detection and treatment is paramount.”

Anyone can develop glaucoma. However, some people are at higher risk than others. They include:

– African-Americans over age 40
– Anyone age 60 and older, especially Hispanics
– People with a family history of glaucoma

Since vision lost to glaucoma cannot be restored, the best way to detect glaucoma is in its early stages by having regular, comprehensive eye exams. A comprehensive exam should include dilating the eyes which allows a doctor to clearly see the retina, optic nerve and vessels in the back of the eye. The exam should also include a test to measure corneal thickness, eye pressure, and a visual field assessment to measure retinal function. African-Americans and Hispanics are genetically more susceptible to glaucoma. Yet, 37 percent of African-Americans and Hispanics did not have their eyes dilated during their last eye exam, according to the American Eye-Q® survey. The AOA recommends eye exams every two years for adults under age 60 and every year thereafter. A doctor may recommend more frequent exams depending upon a patient’s medical or family history.

Treatment for glaucoma includes prescription eye drops and medicines to lower pressure in the eyes. In some cases, laser treatment or surgery may be effective in reducing pressure.

Medicare patients at high risk for glaucoma can receive dilated eye examinations as a benefit of Medicare coverage. Currently eligible beneficiaries are individuals with diabetes mellitus, individuals with a family history of glaucoma, Hispanic-Americans age 65 and over, and African-Americans age 50 and over. The AOA provides a Glaucoma/Diabetes Hotline program which matches patients with participating optometrists in their area. To find an optometrist in your area, please call 800-262-3947.

For additional information on glaucoma and other issues concerning eye health, please visit aoa.

About the survey

The third annual American Eye-Q® survey was created and commissioned in conjunction with Penn, Schoen & Berland Associates (PSB). From May 17-19, 2008, using an online methodology, PSB interviewed 1,001 Americans 18 years and older who embodied a nationally representative sample of U.S. general population. (Margin of error at 95 percent confidence level.)

American Optometric Association

The Discovery Eye Foundation (DEF) is pleased to announce they have received a $2,380,000 grant from The Lincy Foundation, headquartered in Beverly Hills, CA. Their continuing grant support will fund the majority of the Discovery Eye Foundation sponsored research focused on reconstruction of the outer retina by developing clinically useful stem cell and other therapies in an effort to retard and cure Age-Related Macular Degeneration (AMD).

Henry Klassen, MD, PhD, director of the Stem Cell and Retinal Generation Program at the Morris S. Pynoos Eye Research Laboratories, University of California, Irvine School of Medicine and Michael Young, PhD., of Harvard University’s Schepens Eye Research Institute are the two principal investigators. They have been coordinating the cutting-edge research by scientists around the world participating in this collaborative study.

There are 11 universities worldwide participating in the Discovery Eye Foundation supported project. The generous grant from The Lincy Foundation will enable experts from multiple disciplines around the world to continue contributing their knowledge and expertise to this highly successful endeavor. During the first year their innovative work has resulted in six chapters in scientific books, 10 peer-reviewed manuscripts, and numerous presentations on related topics at national and international meetings.

The scientists involved are hopeful that the results of their vision-preserving experiments will be ready for clinical trials in humans within the next couple of years. Thus far, the project’s findings have opened up new ideas about what may be possible in terms of reconstructing the outer retina damaged as a result of AMD. Many years of work have come together through this collaborative project and enabled success where for many years there was frustration.

Scientists involved in the retinal repair consortium are from The University of California, Irvine, Schepens Eye Research Institute at Harvard University, University of Louisville, University of Lunds, Eye Pathology Institute, University of Copenhagen, University of Missouri, Columbia, Massachusetts Institute of Technology, University of California, San Francisco, Boston University, Yale University, Case Western Reserve University.

The Discovery Eye Foundation, a national foundation headquartered in Los Angeles, CA, was founded in 1970 by Rita and Morris S Pynoos, and plays a vital role in finding the causes of and cures for eye disease while helping individuals with vision loss and their families find new way to see the world.

The mission of The Discovery Eye Foundation is to facilitate the development of cures and improve patient care through retinal and corneal research and educational programs for those persons with eye disease. They do this by supporting cutting edge eye research and providing educational programs around the world.

The Discovery Eye Foundation

NICE has published its findings after exploring the feasibility of advising the NHS on the clinical and cost effectiveness of bevacizumab (Avastin, Genentech/Roche) to treat wet age-related macular degeneration (AMD), the leading cause of blindness in the UK, and other conditions affecting the eye. NICE was asked to undertake this work by the Department of Health, who also asked the NHS Health Technology Assessment programme to commission work to identify the existing and expected evidence on the use of bevacizumab in the eye. This work also fed into the NICE report.

The pre-scoping briefing report takes into account comments received from invited stakeholders, most of whom also attended a pre-scoping workshop at NICE in July 2010.

The main conclusion of the report is that there is support for an appraisal of intravitreal[1] bevacizumab for eye conditions. Stakeholders agreed that an appraisal would need to be conditional on, or incorporate the assessment of, the safety and quality of intravitreal bevacizumab by a regulatory body or through the involvement of regulatory expertise. Furthermore, arrangements for safety monitoring / pharmacovigilance[2] will need to be explored.

The next step is for the Department of Health to decide whether or not to refer bevacizumab to NICE for consideration as part of its technology appraisal programme.

Notes

1. The report can be found on the NICE website.

2. Although NICE does not normally appraise drugs outside of their licensed indications it can happen at request of the Department of Health. For example, the Department of Health has previously asked NICE to look at off-label immunosuppressive drugs for renal transplantation in children and adolescents.

3. Wet age-related macular degeneration (AMD) is an eye condition that affects the macula (a tiny part of the retina at the back of the eye). AMD causes problems with central vision, but does not lead to total loss of sight and is not painful.

4. Macular degeneration is diagnosed as either dry (non-neovascular) or wet (neovascular). Neovascular refers to growth of new blood vessels in an area, such as the macula, where they are not supposed to be.

5. Bevacizumab works by stopping tumour growth by preventing the formation of new blood vessels. It does this by targeting and inhibiting the function of a natural protein called vascular endothelial growth factor that stimulates new blood vessel formation.

6. Bevacizumab is currently being used as a treatment for eye conditions by some NHS trusts as an alternative to ranibizumab (Lucentis), which is licensed for AMD and which NICE recommended for use in August 2008 (guidance.nice/TA155).

Footnotes

[1] When drugs are administered through the eyes.

[2] This is the pharmacological science relating to the detection, assessment, understanding and prevention of adverse effects, particularly long term and short term side effects of medicines.

Source:

National Institute for Health and Clinical Excellence (NICE)

View drug information on Avastin; Lucentis.

An estimated 200 people die each year in the U.S. after being struck by lightning. An extremely brief but intense hit delivers more than 10 million volts and is fatal in about 30 percent of cases. Recent lightning strikes in Newark resulted in one death and three injuries.

Most survivors have significant complications. Half of people struck by lightning will suffer rupture of the tympanic membrane in the ear. Many go on to develop cataracts.

“Lightning presents a grave risk of death,” warns Shreni Zinzuwadia, M.D., an emergency department physician at UMDNJ-The University Hospital and instructor of surgery at the UMDNJ-New Jersey Medical School. “Cardiac or respiratory arrest may result from being hit by lightning.”

There are other dangers outside of a direct hit, she added, from three additional types of strikes.

A side strike happens when lightning jumps from its initial point of contact to the victim. “For example, if you seek protection under a tree, which is one of the worst places to be during a storm, the lightning can hit the tree then jump to you, a better conductor of electricity since humans are mostly salty water,” she explained. “This kind of strike can kill the tree and the person.”

A contact strike occurs when lightning hits an object the person is holding or wearing, such as a watch or eyeglasses.

The other type of strike – step potential happens when a current traveling through the ground goes up your leg, travels through you and then goes down the other leg and back into the ground. “That is why Boy Scouts practice standing on one leg during a storm,” she explained. “They are attempting to decrease the likelihood that the current will go through them by having only one foot on the ground.”

Prevention begins by seeking cover at the start of a storm. “Lightning seems to be concentrated at the forefront of a storm,” according to Zinzuwadia, “so there tends to be a greater risk of being hit by lightning at the beginning of a storm.”

According to the Federal Emergency Management Agency (FEMA), part of the U.S. Department of Homeland Security (DHS), individuals who hear thunder roar should go indoors because no place outside is safe when lightning is in the area. Stay indoors until 30 minutes have passed after you hear the last clap of thunder.

Once inside, FEMA advises that people avoid contact with corded phones and electrical equipment or cords; do not wash your hands, take a shower, wash dishes, or do laundry because plumbing and bathroom fixtures can conduct electricity; stay away from windows and doors; stay off porches; and do not lie on concrete floors or lean against concrete walls.

If you are outside during a storm, crouch down and try to touch as little of the ground as you can, Zinzuwadia suggests. “Even if you are hit by the current, the less contact there is between you and the ground, the less likely it is that all of your major organs will be hit,” she says. “It increases your chances of survival.”

What signs might indicate that a person has been struck by lightning? “You may see superficial burns on the skin or clothing may burst into flames or be torn away from the body,” Zinzuwadia said. “A person may fall to the ground.

“People who are hit by lightning commonly die from ventricular fibrillation, asystole (cardiac arrest), or respiratory arrest,” Zinzuwadia added. “Bystanders should immediately check for a pulse and spontaneous breathing.”

Immediately call 911 for help if someone is hit by lightning, Zinzuwadia emphasizes.

If a person is in respiratory arrest has a pulse but is not breathing – provide rescue breaths until the victim resumes spontaneous breathing.

If the victim goes into cardiac arrest, where the heart just stops due to the impact of the massive electrical current, CPR should be administered, Zinzuwadia said. “Give cardiac compressions and provide respiratory support for them.”

The University of Medicine and Dentistry of New Jersey (UMDNJ) is the nation’s largest free-standing public health sciences university with nearly 5,700 students attending the state’s three medical schools, its only dental school, a graduate school of biomedical sciences, a school of health related professions, a school of nursing and a school of public health on five campuses. Annually, there are more than two million patient visits at UMDNJ facilities and faculty practices at campuses in Newark, New Brunswick/Piscataway, Scotch Plains, Camden and Stratford. UMDNJ operates University Hospital, a Level I Trauma Center in Newark, and University Behavioral HealthCare, a statewide mental health and addiction services network.

Source: UMDNJ

Surgical errors, such as operating on the wrong site, the wrong patient or the wrong procedure do not happen often in ophthalmic procedures, according to an article in Archives of Ophthalmology (JAMA/Archives), November issue. These mistakes (“confusions”) do not usually lead to permanent injury – however, they may involve serious consequences for both the patient and the physician. The authors explain that these confusions could often be prevented.

The researchers write “Surgical confusions are an increasingly recognized cause of morbidity, recently representing the most common category of reportable medical error. In July 2004, the Joint Commission on Accreditation of Healthcare Organizations, in concert with many professional organizations, including the American Academy of Ophthalmology, promulgated the Universal Protocol in an effort to prevent such confusions in all surgical procedures. This protocol includes consistent preoperative verification, site marking and a time-out immediately before incision.”

John W. Simon, M.D., of the Lions Eye Institute, Albany Medical College, N.Y., and team looked at 106 cases of surgical confusions involving ophthalmic procedures that took place between 1982 and 2005. 42 of them were from the Ophthalmic Mutual Insurance Company and 64 from the New York State Health Department.

The researchers found that:

— There were 67 wrong lens implant confusions, 63% of all cases. They mainly occurred because the lens specifications were not checked properly beforehand.

— There were 14 cases (13%) of anesthesia being injected into the wrong eye

— There were 15 cases of the wrong eye being operated on (this overlaps with the previous one)

— There were 8 cases of the wrong patient getting the procedure (or the wrong procedure being performed on a patient)

— There were two cases of the wrong tissue being transplanted

The confusions that caused the most severe injuries were those involving the wrong implant or transplant, as opposed to those involving the wrong eye, procedure or patient, the researchers report.

85% of those confusions would not have happened if the Universal Protocol had been implemented.

The researchers worked out that the confusion rate in the USA is 69 per 1 million eye operations.

The authors write “The causes of these confusions were faulty systems, processes and conditions that led people to make mistakes, more often than an individual’s recklessness. The traditional response to medical error, ‘blame, shame and train,’ therefore misses the point. Humiliating or otherwise disciplining caregivers tends to perpetuate a culture of secrecy that impedes effective root-cause analysis and future improvement. A more enlightened approach is entirely non-punitive, drawing on methods of crew resource management adapted from the airlines and the defense department.”

“Surgical Confusions in Ophthalmology”
John W. Simon, MD; Yen Ngo, MD; Samira Khan, MD; David Strogatz, PhD
Arch Ophthalmol. 2007;125(11):1515-1522.
Click here to view Abstract online

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Researchers at National Jewish Health have discovered a promising strategy for destroying the molecular scaffolding that can make Pseudomonas bacterial infections extremely difficult to treat in cystic fibrosis patients, wearers of contact lenses, and burn victims. Jerry Nick, MD, Associate Professor of Medicine at National Jewish Health, and his colleagues report in the April 2009 issue of The Journal of Medical Microbiology that a long string of aspartic acid molecules disrupts the molecular bonds that hold together the structure supporting Pseudomonas biofilms.

“Once a bacterial community forms a biofilm it becomes much more difficult to treat,” said Dr. Nick. “We think our discovery will pave the way for more effective treatment of Pseudomonas aeruginosa infections, which can wreak so much havoc in cystic fibrosis patients.”

Biofilms are a form of bacterial colony in which bacterial cells attach to and live within an extracellular matrix, where medications and the immune system have difficulty reaching them. As a result, these infections become very difficult to treat effectively. Pseudomonas biofilms form and cause lung damage in most cystic fibrosis patients as they grow older. Pseudomonas biofilms can also form on the corneas of contact lens wearers, and in wounds and burns.

Dr. Nick and his colleagues previously showed that formation of Pseudomonas aeruginosa biofilms is enhanced by the remains of immune system cells known as neutrophils, which accumulate in vast numbers to the site of infection, then die and spill their contents. Pseudomonas builds the extracellular matrix from neutrophils’ DNA, the actin structural molecules, and histones, the molecules around which DNA normally wraps inside the cell nucleus.

DNase, an enzyme that breaks long strands of DNA, is already used to help thin the thick mucus that plagues cystic fibrosis patients. Dr. Nick believes it may also break up the Pseudomonas biofilms. But it is clearly not enough, because Pseudomonas biofilms remain one of the most vexing problems for cystic fibrosis patients as they age.

Dr. Nick and his colleagues thought that a negatively charged molecule might help break up the biofilms by bonding to the positively charged histones and preventing them from contributing to the molecular scaffolding, and by breaking apart actin bundles. So, they added aspartic acid polymer, long strings of the negatively charged molecules, to cell cultures of Pseudomonas aeruginosa and neutrophils.

In one experiment, a 48-hour-old Pseudomonas biofilm was reduced by 42 percent when exposed to DNase for 10 minutes. The aspartic acid polymer alone could not reduce the density of the 48-hour-old biofilm. But when both DNase and the aspartic acid polymer were applied to the biofilm, it was reduced by 78 percent. Several other experiments with varying doses and exposure times of DNase and the aspartic acid polymer on different Pseudomonas strains and biofilms had similar results.

“The DNase and aspartic acid worked together synergistically to break down the biofilm,” said Quinn Parks, PhD, lead author on the research paper. “We are now experimenting with different aspartic acid polymers to find the most effective ones. This may be an important new therapeutic strategy for combating Pseudomonas infections.”

Source: Adam Dormuth

National Jewish Medical and Research Center

Highlights of October’s Ophthalmology, the journal of the American Academy of Ophthalmology, include good news on preserving vision in people with type 1 diabetes, a warning from the Cardiovascular Health Study for macular degeneration patients, and a report on how vision impacts well-being across the lifespan.

Today’s Type 1 Diabetes Patients Enjoy Better Vision than Those in Decades Past

People diagnosed with type 1 diabetes (T1D) in recent years are less likely to develop diabetes-related vision loss than those diagnosed in earlier years, says a new study funded by the National Eye Institute, a division of the National Institutes of Health. Forecasts of visual impairment prevalence in T1D patients may need to be amended, the researchers suggest, since current predictions assume that the earlier incidence rates will continue. Ronald Klein, MD, MPH, and colleagues at the University of Wisconsin Department of Ophthalmology and Visual Sciences assessed visual acuity over 25 years in 955 people diagnosed with T1D in one of four time periods, with the earliest defined as “before 1960” and the latest as “1975 through 1979.”

“Visual impairment in T1D patients may be decreasing for several reasons,” Dr. Klein said. “Effective treatments for diabetic retinopathy (DR) and related macular edema became widely available in the 1970s, and earlier screening and detection of DR began in the 1980s. In the 1990s, we learned that intensive control of blood glucose could significantly impact DR progression in T1D, so physicians and patients began closely monitoring this factor and controlling it with diet, exercise and medication.”

Key findings include: among participants who had T1D for 30 to 34 years at the time their eyes were examined for the study, impaired vision was found in 16 percent of those diagnosed from 1922 through 1959, compared with 9 percent of those diagnosed from 1970 through 1974; also, among patients who had T1D for 15 to 19 years at the time they were examined, impaired vision was found in only four percent of those diagnosed from 1975 through 1979.

Signs of Macular Degeneration May Predict Heart Disease

A large study found strong evidence that older people who have age-related macular degeneration (AMD) are at increased risk for coronary heart disease (CHD), although not for stroke. This result adds to mounting evidence that AMD and cardiovascular disease may share some risk factors – smoking, high blood pressure, inflammatory indicators such as C-reactive protein, genetic variants such as complement factor H – and disease mechanisms. The Cardiovascular Health Study (CHS) followed 1,786 white or African American participants, who were free of CHD or stroke at the study’s outset, for about seven years. The CHS received funding from the National Heart, Lung and Blood Institute, a division of the National Institutes of Health.

The incidence of CHD was 25.76 percent in patients with AMD, compared with 18.9 percent in those without AMD. The association between AMD and CHD was somewhat stronger in people age 69 to 78 than age 79 and up. Data were adjusted to counter potentially confounding factors like hypertension, diabetes, and smoking.

“Like the recent findings on older Medicare beneficiaries, our study shows that early AMD may predict the development of CHD in an older population,” said CHS researcher Tien Yin Wong, MD, PhD.

Vision Influences Adults’ Success and Health; Prenatal Factors may be Crucial

Impaired vision is associated with unemployment, low socioeconomic status, and general and mental health problems, says a long-term study by researchers at the Institute of Child Health, University College London. Poor vision was also associated with low birth weight, intrauterine growth retardation, maternal smoking during pregnancy, and socioeconomic deprivation in early childhood. The findings held true for all causes and levels of impairment. This is one of the largest studies to examine the impact of visual disability on social and occupational success.

“It is interesting that key prenatal and childhood factors known to be associated with serious adult health conditions like hypertension are also associated with visual function,” said Jugnoo S. Rahi, PhD, lead researcher on the study. “We think further life-span research will reveal factors that contribute both to complex eye diseases, like glaucoma and macular degeneration, and to other major illnesses that apparently share etiologies with these eye disorders,” she added.

Of 9,330 study participants, 1.3 percent had socially significant visual impairmen – defined as inability to pass a driving test due to visual deficits – and another 0.9 percent had severe visual impairment or blindness. The study examined people at age 44 or 45 for near, distance and stereo visual acuity (the ability of the eyes to coordinate to provide clear images and depth perception). Participants were drawn from the 1958 British birth cohort, comprised of everyone born in Britain within a single week in 1958. Health data gathered in clinical exams from birth to middle age was available for all participants.

Source:
Mary Wade

American Academy of Ophthalmology

pSivida Corp. (NASDAQ:PSDV)(ASX:PVA)(FF:PV3), a leading drug delivery company, today reported that an independent Data Safety Monitoring Board (DSMB) has recommended the continuation of two pivotal Phase III clinical trials for the use of Iluvien™ (formerly known as Medidur FA™) in the treatment of diabetic macular edema (DME) under the current protocol, without change. The clinical trials are being conducted by the company’s licensing partner, Atlanta-based Alimera Sciences, Inc. Top line data from the trials is expected to be available at the end of this year.

The DSMB completed its final review of the currently available safety and efficacy data prior to the 24 month readout scheduled in October 2009. A DSMB provides an independent evaluation of all trial data to identify potential safety issues that might warrant modification or early termination of ongoing clinical studies.

These clinical trials, known collectively as the FAME™ Study (Fluocinolone Acetonide in Diabetic Macular Edema), consist of two 36-month, doublemasked, randomized, multi-center trials in the U.S., Canada, Europe and India in support of a planned global registration filing. The NDA will be filed with safety and efficacy assessed after 24 months of follow-up.

“pSivida is pleased that the DSMB recommended the continuation of the FAME Study without change,” said pSivida CEO Dr. Paul Ashton. “We are looking forward to the last patient’s last visit for the 24-month readout scheduled in October later this year. The NDA filing for Iluvien remains on schedule for early 2010.” He added, “This is another positive development for Iluvien. Last month the company reported very encouraging 12-month interim safety and efficacy data from the first human pharmacokinetic (PK) study of Iluvien which continued to be consistent with our expectations regarding Iluvien.”

About Iluvien™

Iluvien is an intravitreal insert being developed for the treatment of DME. DME is a disease of the retina, which affects individuals with diabetes and can lead to severe vision loss and blindness. Each Iluvien insert is designed to provide a sustained therapeutic effect, up to 36 months for the low dose and up to 24 months for the high dose. Iluvien is inserted into the patient’s eye with a 25-gauge needle, which allows for a self-sealing wound. This insertion is very similar to an intravitreal injection, a procedure commonly employed by retinal specialists.

About pSivida Corp.

pSivida is a world leader in the development of miniaturized, injectable, drug delivery systems for the eye. pSivida’s lead development product, Iluvien™, delivers fluocinolone acetonide (FA) for the treatment of diabetic macular edema (DME). Formerly known as Medidur™ FA for DME, Illuvien is in fully recruited Phase III clinical trials. pSivida has licensed certain drug delivery technology to Alimera Sciences, Inc. for the development of Iluvien and certain other ophthalmic products. pSivida also has two products approved by the Food and Drug Administration (FDA): Retisert® for the treatment of uveitis and Vitrasert® for the treatment of AIDS-related cytomegalovirus (CMV) retinitis. pSivida has licensed both of these products and the technologies underlying them to Bausch & Lomb Incorporated. pSivida has a worldwide collaborative research and license agreement with Pfizer Inc. under which Pfizer may develop additional ophthalmic products.

pSivida owns the rights to develop and commercialize a modified form of silicon known as BioSilicon™, which has potential therapeutic applications. The most advanced BioSilicon product candidate, BrachySil™, delivers a therapeutic P32, a radioactive form of phosphorus used to treat cancer, directly to solid tumors. pSivida has completed an initial safety and efficacy clinical trial of BrachySil for the treatment of pancreatic cancer and is conducting a follow-on dose-ranging clinical trial.

pSivida’s intellectual property portfolio consists of 45 patent families, over 100 granted patents, including patents accepted for issuance, and over 200 patent applications. pSivida conducts its operations from Boston in the United States and Malvern in the United Kingdom.

Safe Harbor Statements Under The Private Securities Litigation Reform Act Of 1995

Various statements made in this release are forward-looking and involve a number of risks and uncertainties. All statements that address activities, events or developments that we intend, expect or believe may occur in the future are forward-looking statements. The following are some of the factors that could cause actual results to differ materially from the forward-looking statements: maintaining key collaboration agreements with Alimera and Pfizer; modification of existing terms of key collaboration agreements with Alimera and Pfizer; uncertainties regarding the achievement of milestones and other contingent contractual payment events; failure to prove safety and efficacy of Iluvien or BrachySil; inability to raise capital; continued losses and lack of profitability; inability to derive revenue from Retisert; termination of license agreements; inability to pay any registration penalties; inability to develop or obtain regulatory approval for new products; inability to protect intellectual property or infringement of others’ intellectual property; inability to obtain partners to develop and market products; competition; risks and costs of international business operations; manufacturing problems; insufficient third-party reimbursement for products; failure to retain key personnel; product liability; failure to comply with laws; failure to achieve and maintain effective internal control over financial reporting; impairment of intangibles; volatility of stock price; possible dilution through exercise of outstanding warrants and stock options or future stock issuances; possible influence by Pfizer; and other factors that may be described in our filings with the Securities and Exchange Commission. Given these uncertainties, readers are cautioned not to place undue reliance on such forward-looking statements. We do not undertake to publicly update or revise our forward-looking statements even if experience or future changes make it clear that any projected results expressed or implied in such statements will not be realized.

Source
pSivida Corp

View drug information on Vitrasert Implant.

The results of a new study reinforce an advisory that patients taking Flomax® (Tamsulosin) to treat prostate enlargement and urinary problems should inform their ophthalmologist about their use of this drug before undergoing eye surgery. The advisory was issued by the American Academy of Ophthalmology (Academy) and the American Society of Cataract and Refractive Surgery (ASCRS) and updates the advisory the organizations released in 2006. The new study, published last month in the Journal of the American Medical Association, found that the alpha-blocker Flomax increased the risk of certain complications following cataract surgery.

Advice for patients: Men and Women

Patients who take alpha-blockers or are considering taking alpha-blockers should be aware that the drugs may increase the difficulty of cataract surgery. While Flomax is largely prescribed to men to treat prostate enlargement, some women also take the drug to treat urinary retention problems. Other alpha-blockers are used to treat hypertension.

It is important that patients inform their ophthalmologist whether they are currently taking alpha-blockers, such as Flomax, or did so in the past. Once informed, the ophthalmologist can anticipate certain problems and employ different surgical techniques that help to achieve excellent outcomes. Patients should not decide on their own to discontinue their prostate/alpha-blocker drugs without consulting their prescribing physician.

Before being started on an alpha-blocker medication for the first time, patients who already have cataracts should understand that these drugs can complicate cataract surgery later on. For this reason, they may want to discuss the risks and the timing of their operation with their ophthalmologist performing cataract surgery.

“There are many factors that a prescribing doctor considers in selecting a medication to treat prostate enlargement,” said David F. Chang, MD, one of the investigators who first identified the effect that Flomax can have on cataract surgery. “Cataract surgeons can provide additional counsel about how Flomax might affect an individual patient’s risk for eye surgery, and whether stopping, delaying, or avoiding the drug is advisable. In addition, many ophthalmologists believe that other alpha-blockers pose less surgical difficulty and risk compared to Flomax.”

It is also important to reassure patients already taking Flomax that they have an excellent prognosis for successful cataract surgery, as long as their ophthalmologist performing eye surgery is forewarned. “Even with Flomax, the overall risk of serious cataract surgical complications is very low, and patients needn’t otherwise avoid or delay recommended surgery,” Dr. Chang said.

Background

Cataracts and prostate enlargement are very common age-related conditions. A cataract is a progressive clouding of the lens of the eye and is the most common age-related cause of worsening vision. Ophthalmologists treat cataracts by surgically removing the cloudy natural lens and replacing it with a clear artificial lens implant.

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.

Source
American Society of Cataract and Refractive Surgery

View drug information on FLOMAX.