Avastin/Lucentis Update 39: And the Controversy Continues

By Alicia Mundy

Medicare could save more than $500 million annually by using a cheaper Genentech drug to save vision, according to a draft study by federal officials and a University of Miami eye doctor.

The study shows that the cheaper drug, Avastin, is already used in about 65% of Medicare patients with wet age-related macular degeneration and accounts for nearly 60% of their eye injections, compared with about 40% for a more expensive drug called Lucentis. However, Medicare paid $537 million for Lucentis in 2008 and only $20 million for Avastin, according to the unpublished study, which was reviewed by The Wall Street Journal.

The numbers point to a delicate problem for the federal program for the elderly, whose rising costs are often cited as among the biggest long-term factors in the federal budget deficit. Both drugs are made by Genentech, but only Lucentis is approved by the Food and Drug Administration to treat the disease, the leading cause of irreversible blindness among older people.

Clinical trials suggest that Avastin, approved by the FDA to treat some forms of cancer, is also effective in treating the eye disease. Doctors have been "voting for Avastin with their feet," said Philip Rosenfeld, a retina specialist at the University of Miami's Bascom Palmer Eye Institute and one of the study's authors. Some pharmacies take supplies of Avastin and divide it into tiny doses suitable for injection in the eye.

The study, based on data from more than 200,000 Medicare patients, found that Medicare paid on average $42 a dose for Avastin in the eye, compared with $1,593 a dose for Lucentis.

Leading brands under threat

Ophthalmology encompasses some lucrative markets, but the future of leading brands in AMD is under threat, and while established markets like glaucoma and conjunctivitis have many therapeutic options, diabetic retinopathy remains largely untapped. Key opinion leaders agree there is unmet need in terms of drug delivery methods and dose frequency across ophthalmology diseases.

Highlights

The future of leading brands Lucentis (ranibizumab) and Xalatan (latanoprost) is at risk. Lucentis dominates AMD with 91% market share but the use of currently off-label Avastin (bevacizumab, Roche) is a threat. Xalatan, the gold standard in glaucoma achieved $1.5 billion in 2008 but the drug faces generic erosion after patent expiry in 2011

Diabetic retinopathy and AMD markets show high growth potential. Both diseases are highly prevalent, with 11.5 million cases of diabetic retinopathy, and 7.5 million in AMD, in the seven major markets in 2010. There are few drug treatments for AMD, while no approved drugs for diabetic retinopathy mean this market is untapped.

Key opinion leaders report high unmet need for reduced dosing regimens of existing therapies and an improvement in drug delivery methods. However, any new formulations of existing drugs will have to compete with cheap generics and need to show significant additional benefits.

Reasons to Purchase

*Validate the market potential of particular ophthalmology indications based on prevalence numbers in each of the seven major markets

*Understand the commercial potential of ophthalmic diseases with Datamonitor’s assessment of market and brand dynamics

*Assess the key unmet needs and possible new approaches in the treatment of eye diseases as noted by opinion leaders

Ophthalmology market attractiveness
ophthalmology market definition
Therapeutic sales for ophthalmology disorders exceeded $12 billion in 2008
High growth potential observed in diabetic retinopathy and age-related macular degeneration markets
Age-related macular degeneration shows a high growth rate, and seemingly unsaturated market
Middle Eastern, North African (MENA) and Brazil, Russia, India and China (BRIC) ophthalmology markets are growing rapidly
High pipeline potential in age-related macular degeneration (AMD)
to greater patient compliance
Preservative-free formulations
Therapies with better side-effect profiles
Pipeline analysis of glaucoma treatments
Chapter 3. Age-related macular degeneration
Key findings 70
Definition and classification of age-related macular degeneration (AMD)
Dry (nonexudative) age-related macular degeneration
Wet (exudative/neovascular) age-related macular degeneration
Epidemiology of age-related macular degeneration (AMD)
Over 7.5 million sufferers of age-related macular degeneration in the seven major markets in 2010
estimates over 2.7 million cases of age-related macular degeneration in the US in 2010
Japanese males have higher prevalence of age-related macular degeneration
estimates over 4.3 million cases of age-related macular degeneration across the five major EU markets in 2010
Age-related macular degeneration prevalence is high in India
Age-related macular degeneration prevalence varies in racial groups
Current treatment options in age-related macular degeneration (AMD)
Overview of treatments in age-related macular degeneration (AMD)
Anti-vascular endothelial growth factor (VEGF) therapy
Off-label use of Avastin in age-related macular degeneration
Laser photocoagulation and photodynamic therapy
Other surgical treatments for AMD
Vitamins and lifestyle change are the main treatment options in dry AMD
Age-related macular degeneration (AMD) treatment guidelines Diagnosis of AMD
Treatment guidelines on the management of AMD
Sales analysis of brands in age-related macular degeneration (AMD)
Lucentis drives rapid growth in AMD market between 2004 and 2008
Major brands in AMD therapy
Lucentis (ranibizumab, Roche/Novartis/Alcon)
Macugen (pegaptanib, Eyetech/Pfizer)
Visudyne (verteporfin, QLT /Novartis)
Avastin (bevacizumab, Roche)

Alcon Terminates the Development of Anecortave Acetate in Age-Related Macular Degeneration

HUENENBERG, Switzerland -- Alcon, Inc. (NYSE:ACL) announced today it has terminated the development program designed to evaluate the benefit of anecortave acetate treatment on the risk for developing sight-threatening choroidal neovascularization secondary to age-related macular degeneration. The decision followed a planned interim analysis of studies C-02-60 A and B that was performed after 2,546 patients had completed the 24 month time point. In this analysis, anecortave acetate showed no effect on the primary or secondary endpoints. In addition to terminating studies C-02-60 A and B, the company also terminated two smaller studies with an identical design that were being conducted in Asia, C-04-30 and C-05-34.

The company continues to study anecortave acetate administered as an anterior juxtascleral depot to reduce intraocular pressure in patients with open-angle glaucoma.

About Alcon

Alcon, Inc. is the world's leading eye care company, with sales of approximately $5.6 billion in 2007. Alcon, which has been dedicated to the ophthalmic industry for more than 60 years, researches, develops, manufactures and markets pharmaceuticals, surgical equipment and devices, contact lens care solutions and other vision care products that treat diseases, disorders and other conditions of the eye. Alcon's majority shareholder is Nestle, S.A., the world's largest food company. For more information on Alcon Inc., visit the company's Web site at www.alcon.com.

Artificial Retina offers new Hope

TUCSON - There is new hope for millions of people losing their vision. Many are going blind because of age-related macular degeneration and other conditions. But a new device called Artificial Retina has people seeing and believing.

Dean Lloyd is one of 14 people in the United States seeing through an Artifical Retina. He lost his vision in 1974. Lloyd says, "I almost lost all my vision in six months." Then in 2007, after a three hour operation, his sight, though limited, returned. "The beauty of the human brain is when you've had sight at one time, the brain seems to save the images," he said.

The camera on Dean's glasses captures an image and sends it wirelessly to an implant in his eye that stimulates his optic nerve to create an image in his brain. The next generation for Dean's implant is one that could help him see details and faces.

Satinderpall Pannu heads the Artificial Retina project at Lawrence Livermore labs in California. Starting with a silicon wafer and a thin coating of polymer, the disk is processed, electrodes are added and the implant is encased in titanium and gold, "It's a very rewarding feeling. It's amazing to me that technology that we've developed here at the lab can actually restore someone's sight," Pannu said.

Pannu says in 10 years, 50 million people in the world will suffer from blindness that these implants could reverse, "We really would like to take this tech to have a digital camera embedded in your retina and be able to restore your vision completely."

The only clinical trials for the artificial retina in the U.S. are run through a California Company "Second Sight."

Project leaders at Lawrence Livermore say they only have funding through next year. Right now, they're trying to lobby congress to extend the project's 8-million dollar a year budget, to improve the implant.

Miniature Telescope for Eye Approved for Macular Degeneration

TUESDAY, July 6 (HealthDay News) -- A tiny telescope that's implanted in an eye affected by advanced age-related macular degeneration (AMD) has been approved by the U.S. Food and Drug Administration.
The Implantable Miniature Telescope replaces the natural lens and magnifies an image more than two times, the FDA said in a news release.
The device is meant for people aged 75 and older who have blind spots associated with end-stage AMD. Candidates will be trained with an external telescopic device to see if they may benefit from the implanted product, the agency said.
AMD damages the eye's macula, causing vision loss in the center of the visual field. The condition affects mostly older people, often making it impossible to recognize faces or perform tasks such as watching television, the FDA said. Some 8 million Americans have been diagnosed with the condition, and about 25 percent of those are significantly visually impaired.
The FDA said it's requiring the labeling to warn that the device puts users at greater risk of injury to the eye's cornea.
As a condition of approval, California-based VisionCare Ophthalmic Technologies will conduct two follow-up studies of the device, the agency said.
More information
To learn more about AMD, visit the U.S. National Eye Institute.

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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

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