Saturday, December 27, 2008

PSivida's eye treatment in trials for macular degeneration

By Mass High Tech staff

PSivida Ltd., an Australian drug company with U.S. headquarters in Watertown, has announced that its Medidur technology, licensed to Alimera Sciences Inc., has begun an early-stage clinical trial for treating macular degeneration. The technology is currently in Phase 3 clinical trials for treating a different disease associated with blindness, diabetic macular edema.

Medidur is a tiny insert, injected during an in-office procedure, which is being studied as a way to deliver a low dose of fluocinolone acetonide, a corticosteroid, to the retina for up to three years as a treatment for DME. To be marketed by Alimera, a privately held ophthalmic pharmaceutical company, the product will go by the name Iluvien if it is approved by the U.S. Food and Drug Administration, pSivida (Nasdaq: PSDV) (ASX: PSD) (FSE: PSI) officials said.

The study is expected to evaluate the effectiveness of Illuvien in treating dry-age related macular degeneration in patients with bilateral geographic atrophy.

In a previous study conducted on animals, Iluvien showed signs of preventing macular degeneration.

Alimera Sciences and pSivida have a worldwide agreement to co-develop and market the Medidur insert for the use of fluocinolone acetonide to treat DME. The agreement also includes the option to identify other compounds for ophthalmic diseases, potentially resulting in three additional products with the Medidur insert.

Tuesday, December 16, 2008

PSivida's eye treatment in trials for macular degeneration

By Mass High Tech staff

PSivida Ltd., an Australian drug company with U.S. headquarters in Watertown, has announced that its Medidur technology, licensed to Alimera Sciences Inc., has begun an early-stage clinical trial for treating macular degeneration. The technology is currently in Phase 3 clinical trials for treating a different disease associated with blindness, diabetic macular edema.

Medidur is a tiny insert, injected during an in-office procedure, which is being studied as a way to deliver a low dose of fluocinolone acetonide, a corticosteroid, to the retina for up to three years as a treatment for DME. To be marketed by Alimera, a privately held ophthalmic pharmaceutical company, the product will go by the name Iluvien if it is approved by the U.S. Food and Drug Administration, pSivida (Nasdaq: PSDV) (ASX: PSD) (FSE: PSI) officials said.

The study is expected to evaluate the effectiveness of Illuvien in treating dry-age related macular degeneration in patients with bilateral geographic atrophy.

In a previous study conducted on animals, Iluvien showed signs of preventing macular degeneration.

Alimera Sciences and pSivida have a worldwide agreement to co-develop and market the Medidur insert for the use of fluocinolone acetonide to treat DME. The agreement also includes the option to identify other compounds for ophthalmic diseases, potentially resulting in three additional products with the Medidur insert.

Friday, December 12, 2008

Clinical Trial for Macular Degeneration Seeks a New Way of Seeing

The brain's remarkable ability to reorganize itself to compensate for vision loss, the ability called plasticity, may be the key in helping those with age-related macular degeneration (AMD) see better. This theory is the impetus behind a study between Emory Eye Center and the Georgia Institute of Technology (Psychology). Patients who have retinal damage because of AMD sometimes begin to see by using other parts of the intact retina. By "training" these patients to focus on using those good retinal cells, they may experience increased visual acuity.

Susan Primo, OD, MPH, of Emory Eye Center, says the Phase 2 portion of the clinical trial "Age-Related Macular Degeneration and Cortical Reorganization" will help bridge the knowledge gap between cortical plasticity and visual function.

"Results from these studies will begin to provide answers for how behavioral improvements in AMD patients can lead to changes in underlying brain activity and, most importantly, how we can influence those changes to maximize use of remaining vision," Primo says. "Once this link is made, clinicians and healthcare engineers can use the information to design and implement rehabilitation therapies and technologies that will expedite efficient use of fixation strategies ultimately fostering cortical reorganization."

Age-related macular degeneration is the leading cause of blindness in the elderly, accounting for 10 million people who have reduced vision in the United States (Research to Prevent Blindness). AMD is a disease associated with aging that gradually destroys sharp, central vision. Central vision is needed for seeing objects clearly and for common daily tasks such as reading and driving. People in middle-age have about a 2 percent risk of getting AMD, but this risk increases to nearly 30 percent in those over age 75. More than 200,000 develop AMD each year in this country.

"Visual rehabilitation is entering an exciting area of research that expands our current understanding of neuroplasticity of the visual system," says Timothy W. Olsen, director of Emory Eye Center and a retina specialist. "Findings from this study and others may help us understand the tremendous capacity of our central nervous system, especially as it relates to sensory deficits. Combining expertise of the Emory Eye Center with Georgia Tech opens exciting new opportunities in vision research."

Phase 1 of the study appears in the December edition of the journal Restorative Neurology and Neuroscience (Restor Neurol Neurosci. 2008;26(4-5):391-402.)

Phase 1 of the trial at Emory involved seven patients, and the Phase 2 portion at Emory will have 10 patients. The goal will be to study hundreds of patients in the near future. Results will be disseminated in late 2009.

Funding is provided through the Health Systems Institute Seed Grant, a collaboration between Georgia Institute of Technology and Emory University/Children's Healthcare of Atlanta/Egleston. The HSI Seed Grant supports collaborative and interdisciplinary research projects that will help stimulate innovative healthcare research and promote improvements in healthcare. The seed grant awards are specifically designed to provide funding for novel projects that demonstrate a high potential for enhanced diagnostic capabilities of diseases, lead to new inventions that yield new patents, licenses and/or commercial products, lead to high quality peer-reviewed publications and those with high potential to leverage seed funding into extra-mural support.

About Emory Eye Center: The Department of Ophthalmology and Emory Eye Center have a mission to conduct pioneering research into blinding eye diseases, to educate and train eye professionals, and to provide excellent patient care. The Department includes 35 ophthalmologists, seven optometrists, nine basic scientists, 11 post-doctoral fellows, and nine researchers in other Emory departments who hold joint appointments in the Department of Ophthalmology. Ophthalmology research is supported by $6 million in NIH funding. The Department remains in the top rankings (#9 -- 2008) by U.S. News & World Report for the 12 years the magazine has held a ranking for Ophthalmology. It also ranks in the Top Ten in all four categories surveyed by Ophthalmology Times annual report.

The Robert W. Woodruff Health Sciences Center of Emory University is an academic health science and service center focused on missions of teaching, research, and health care. Its components include schools of medicine, nursing, and public health; the Yerkes National Primate Research Center; the Emory Winship Cancer Institute; and Emory Healthcare, the largest, most comprehensive health system in Georgia. The Health Sciences Center has a $2.3 billion budget, 17,000 employees, 2,300 full-time and 1,900 affiliated faculty, 4,300 students and trainees, and a $4.9 billion economic impact on metro Atlanta.

Tuesday, December 9, 2008

Study Shows Lutein and Zeaxanthin Protect Against Age-Related Macular Degeneration

by David Gutierrez, staff writer

(NaturalNews) Researchers from Ohio State University may have discovered a mechanism by which proteins known as xanthophylls help prevent against age-related vision loss, they reported in a study published in the Journal of Lipid Research.

"Our research to understand this mechanism might provide a greater appreciation for how one could intervene to possibly slow macular degeneration," said senior study author Earl Harrison.

Age-related macular degeneration is one of the most common causes of age-related vision loss and affects approximately 10 million people in the United States. The deterioration of the macula, a tissue located in the center of the retina, causes vision in the center of the eye to blur, which lead to functional blindness. The condition cannot be reversed once it develops; it can only be slowed.

Prior research has suggested that the xanthophyll proteins lutein and zeaxanthin may protect against the eight-related macular degeneration by filtering out potentially harmful light from the blue end of the spectrum and also protecting the eye against damage from oxidation. The two proteins have been observed to concentrate in the macula, forming a yellow spot.

In the current study, researchers tested the hypothesis that the xanthophylls are transported to the macula by proteins known as scavenger receptor class B, type 1 (SR-B1). They treated pigment cells from the lining of the human retina with lutein, zeaxanthin and the related compounds beta-carotene, finding that the cells absorbed more xanthophylls than they did beta-carotene.

The researchers then blocked the action of SR-B1 by one of two methods. Both of the methods led to a decrease in xanthophyll of distortion of 41 to 87 percent.

Lutein and zeaxanthin cannot be synthesized by the body, but must be consumed in foods such as green, leafy vegetables, peas, summer squash, or yellow and orange fruits and vegetables (including carrots, papaya and peaches).

Sources for this story include: www.sciencedaily.com.

Sunday, December 7, 2008

Avastin problems crop up for eye patients

'They’re taking it out of its (original) packaging, repackaging it and injecting it into people’s eyes'

TORONTO — Public health authorities in Canada are investigating a spike in cases of eye inflammation among patients being treated for macular degeneration with the cancer drug Avastin.

First noticed in British Columbia, there appears to be a rise in cases in other parts of the country as well.

And now authorities are trying to draw the potential problem to the attention of the global public health community in the hopes of seeing if it is being observed elsewhere.

The problem is believed to stem from a particular lot of the drug that was distributed widely around the world, though not to the United States. The lot number is B3002B028.

The drug’s manufacturer, the Swiss pharmaceutical firm Roche, is co-operating with Health Canada and the British Columbia Centre for Disease Control, which was alerted to the problem by ophthalmologists.

The situation puts Roche in an awkward position. Avastin is a colon cancer drug; it is not approved for use as a treatment age-related macular degeneration.

And Roche doesn’t want to encourage the off-label use of the drug by ophthalmologists who have embraced it as a much cheaper alternative to a similar drug, Lucentis, which has been approved as a treatment for macular degeneration.

"Absolutely we do not recommend this," said Samantha Ouimet, a spokeswoman for Roche Canada.

"They’re taking it out of its (original) packaging, repackaging it and injecting it into people’s eyes. This comes in a bag and it’s meant for intravenous use for people with cancer."

Ouimet said the company is in discussions with Health Canada. But it is reluctant to put out an advisory warning people not to use the drug as a treatment for age-related macular degeneration when the drug was never approved for this purpose.

Any statement could be seen as promoting the off-label use, Ouimet said.

"Is it a delicate situation? Absolutely."

Ophthamologists in British Columbia started noticing a problem in October.

A small portion — under two per cent — of people treated for age-related macular degeneration with Avastin will develop acute intra-ocular inflammation. But between Oct. 3 and Oct. 27, the rates were much higher.

The BC CDC was called in to help investigate the cluster of cases. And they concluded that the rate of inflammation among patients treated with Avastin from the lot in question was almost 10 times higher than the normal rate. The lot is no longer in use there.

Dr. David Patrick, the centre’s director of epidemiology services, submitted a report on the investigation to ProMED, an electronic reporting system that sends out alerts about outbreaks to a mailing list of public health officials, scientists and other interested parties around the world.

Patrick said the team investigating the issue sent out feelers to ophthamologists in about a half-dozen other Canadian centres and has heard back that others too have noticed an increase in cases of inflammation after use.

The inflammation causes cloudy vision, but appears to clear up over time, he said.

Ouimet said there have been no reports of problems from other countries — and no reports of adverse reactions in cancer patients who received treatments from the same lot.

"We have reviewed all the analytical release data for the lot in question. And all the best parameters were within the limits for use in oncology," she said.

"So we found no deviations in the manufacturing process. All the environmental testing was fully compliant. We’ve revisited the batch. It is safe . . . for its indicated purpose."

Patrick said scientists at the University of British Columbia are studying vials of the drug. But so far they haven’t found anything usual.

"On the initial go-through they haven’t determined a chemical difference between the implicated lot and another one. But there may well be further work with that," he said.