Wednesday, June 30, 2010

Alimera seek NDA for diabetic macular degeneration drug/device combo

June 29, 2010 by MassDevice staffpSivida Corp. and Alimera Sciences file a new drug application with the Food & Drug Administration for Iluvien, a drug/device combination aimed at treating diabetic macular degeneration.

pSivida Corp. (NSDQ:PSDV) and Alimera Sciences (NSDQ:ALIM) are seeking a green light from the Food & Drug Administration for a drug/device combination to treat diabetic macular degeneration.

Watertown, Mass.-based pSivida said Alimera, which licenses the Iluvien technology from pSivida, submitted a new drug application to the FDA. The technology is designed to deliver sustained, low doses of flucocinolone acetonide to the retina at the rear of the eyeball.

Alimera asked the federal watchdog for priority review, an expedited process that could bring an FDA response during the fourth quarter, according to a press release.

There are no approved drugs to treat DME, according to pSivida president and CEO Paul Ashton, adding that Iluvien is the company's third product aimed at back-of-the-eye diseases. The first two won FDA approval and are on the market, Ashton said: Retisert, for the treatment of posterior uveitis, and Vitrasert for the treatment of AIDS-related cytomegalovirus retinitis. Both are licensed to Bausch & Lomb Inc.

The company is also working on a treatment for retinitis pigmentosa, which involves the gradual deterioration of the rods and cones that make up the retina. In April Ashton told MassDevice that its Durasert device also uses flucocinolone acetonide, a steroid, to treat the disease.

"What we've done is use a very small insertable drug delivery device to release a steroid directly into the eye that will just provide some protection and slow down the rates of vision loss," he said. "With a condition that takes 20 years to make you blind, if you slow it down by a factor of two, that's pretty good."

The partnership with Alimera has already paid dividends, namely a $15.3 million payment triggered by Alimera's April 21 initial public offering. At the time Ashton told us pSivida planned to use the cash to further develop its product pipeline. If the FDA gives the nod to Iluvien, it would trigger another, $25 million milestone payment from Alimera, plus 20 percent royalties on net profits from sales of the treatment.

For more information go to www.maculardegenerationassociation.org

Thursday, June 10, 2010

Researchers create retina from embryonic cells

By Adrian Galbreth

Researchers in the US have successfully created a retina from human embryonic stem cells, which offers hope to millions with degenerative eye disorders.

Experts at the University of California Irvine created an eight-layer, early stage retina from human embryonic stem cells, which is the first ever three-dimensional tissue structure to be made from stem cells.

Study leader Hans Keirstead of the Reeve-Irvine Research Center and the Sue and Bill Gross Stem Cell Research Center at the facility, said the process also marks the first step towards the development of transplant-ready retinas to treat conditions such as retinitis pigmentosa and macular degeneration, a leading cause of blindness.

"We made a complex structure consisting of many cell types. This is a major advance in our quest to treat retinal disease," he explained.

Recently, German research centre Fraunhofer-Gesellschaft claimed that a new implant made of plastic could soon offer patients the chance to see again without having to wait for cornea transplants.ADNFCR-1853-ID-19804594-ADNFCR

Wednesday, June 2, 2010

New Drugs for Macular Degeneration

By Emily Singer

Two genetic studies of people with age-related macular degeneration (AMD)--the most common cause of blindness in people older than 65--made a surprising discovery. Research showed that defects in a gene that is an important regulator of parts of the immune system significantly increased risk of the disease. Scientists have since identified variants in several related genes that also boost risk, and which collectively account for about 50 to 60 percent of the heritability of the disorder.

At the same time that researchers identified the harmful variation linked to AMD, Gregory Hageman, now at the University of Utah, identified a protective variant found in about 20 percent of the population. "That form is so incredibly protective that people with two copies are almost guaranteed not to develop the disease," he says. Hageman founded Optherion, a startup based in New Haven, CT, and investigated how to translate the findings into new treatments. Optherion is now producing large quantities of an engineered version of the protein and doing preclinical safety and effectiveness testing--for example, examining whether the treatment can reduce ocular deposits in mice that lack the protein, says Colin Foster, Optherion's president. He declined to estimate when the company will begin clinical trials of the drug.

Scientists hope that these developments will prove to be an example of the benefits that can arise from a type of genetic study called genome-wide association. The genome-wide studies of macular degeneration were among the first and perhaps the biggest success for the approach, which employs specially designed chips dotted with markers to cheaply detect hundreds of thousands of the most common variations in the human genome. While these chips have allowed scientists to cheaply scan the genomes of many patients and healthy controls, the approach has come under increasing scrutiny in the last couple of years. Even huge studies of thousands of people have failed to identify the majority of the heritability of common diseases, such as type 2 diabetes or Alzheimer's disease.