FDA Fast Tracks DRY Macular Degenerations Drug Test

March 21, 2010

Acucela Inc., a clinical-stage biotechnology company focused on developing new treatments for blinding eye diseases, and Otsuka Pharmaceutical Co., Ltd.,announced that they have received Fast Track designation from the US Food and Drug Administration (FDA) for ACU-4429, an investigational oral treatment for dry age-related macular degeneration (dry AMD). The FDA’s Fast Track programmes are designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. Fast Track designated programs may be eligible for priority regulatory review by the FDA.

ACU-4429 is administered to patients as an oral, daily pill rather than by injection into the eye, which is typical of many current eye therapeutics.



Israel Develops Retinal Implant

March 18, 2010

An Israeli company is featured in the Wall Street Journal for restoring the sight of patients who have lost vision due to retinal disease, such as macular degeneration, retinitis pigmentosa or diabetic retinitis.

Herzliya-based Nano Retina has developed a two-part system to replace the function of a retina which has been damaged by macular degeneration, diabetic retinopathy, and other diseases. Called Bio-Retina, the device consists of an implant and set of glasses which coordinate to restore lost sight. The operation to install the electrode-laden implant takes a mere half hour under local anesthetic.

The bionic implant does the work of the eye’s photoreceptors, which normally turn light into electrical signals sent to the brain. The Bio-Retina transforms the light into the electrical signals, which then travel to the brain.

After applying a local anesthetic, a surgeon makes a small — about a centimeter — incision in the cornea and uses biological glue to attach the Bio-Retina implant on top of the damaged retina. The procedure takes about half an hour.

“The interface between the retina and the photoreceptors [is created] by very tiny electrodes” 3 to 4 microns in size, Nano-Retina’s Yossi Gross says. “When the light … goes to the retina, it enters the Bio-Retina implant.” The implant then closes the vision loop, transforming the light into the electrical signals that reach the brain and create sight.

“The current plan is for gray-scale vision, more than just black and white. We believe that this high-resolution technology can bring us closer to color vision down the road.”

Previous artificial retinas have a resolution of 10 x 10. The Bio-Retina’s resolution is up to 72 x 72.

Powering the implant wirelessly is a tiny infrared laser that sits on a pair of eyeglasses that the patient wears. The glasses also carry normal corrective lenses for those who would need them.

For now, Bio-Retina works in gray-scale, but is expected to be developed for color vision. It is currently estimated at $60,000.

Nano Retina may begin tests on U.S. patients in 2013, thanks to a grant by U.S.-Israel industrial cooperation group Bi-National R&D Foundation, according to the Journal.



Cancer Research leads to AMD Treatment.

March 15, 2010

Linda Fugate writes in the EmpowHer blog:

Cancer research has opened a new avenue of treatment options for neovascular eye conditions, including age-related macular degeneration and diabetic retinopathy. The common factor is the growth of abnormal new blood vessels. In the case of cancer, a solid tumor must have a blood supply in order to grow. The tumor tricks the circulatory system into providing it with new blood vessels, in a process called angiogenesis. In the wet form of macular degeneration, new blood vessels grow under the retina and leak blood, which interferes with retinal function. Researchers have identified a protein called vascular endothelial growth factor, VEGF, which is involved in the process of blood vessel growth. Drugs that block the function of VEGF are used to treat both cancer and neovascular eye conditions.

The first drug approved to treat wet macular degeneration was Macugen (pegaptanib). This is a VEGF receptor that binds to one form of VEGF. It has been successful in stabilizing vision, but not in producing improvements.

Lucentis (ranibizumab) is a monoclonal antibody fragment that targets VEGF, and is approved for wet age-related macular degeneration. According to Reference 2, this is the first treatment that can actually improve the patient’s visual acuity.

Avastin (bevacizumab) is a complete monoclonal antibody that targets VEGF. It is not yet FDA approved for eye conditions, but it is currently being studied in 1,075 clinical trials, of which 103 are for macular degeneration and 127 for retinopathy. It is approved for breast cancer, colorectal cancer, lung cancer, glioblastoma, and kidney cancer.

Before the introduction of VEGF inhibitor drugs, the primary treatment for macular degeneration was photodynamic therapy, with the drug Visudyne (verteporfin) injected into a vein to direct the laser to the leaky blood vessels. This treatment helps stop the progression of the disease, but it is not a cure and may cause scarring. Multiple treatments may be required, as new blood vessels continue to grow.

Unfortunately, drug treatment for macular degeneration is not as simple as taking a pill. The drugs must be injected into the eye, in a procedure not much simpler than the laser surgery.


Macugen web site:

Lucentis web site:

Avastin web site:

American Macular Degeneration Foundation web site:

Bevacizumab (Avastin) clinical trials:


Assistives in Windows 7

March 9, 2010

Windows 7 has tools for low vision

Previous Windows software has offered screen magnification features, but they have often disappointed people with visual impairments. Windows 7 offers a magnifier that is simpler to use and has more display capabilities than previous versions. With the ability to magnify up to 16x, the magnifier makes Windows 7 more accessible than previous versions.

  • Fullscreen magnification
  • Magnifying glass mode, square or round
  • The dock view splits the screen, magnifying the top portion only
  • Variable colors and contrast

Additional Windows 7 accessibility features include enhanced speech recognition, an on-screen keyboard, a narrator function that helps guide the user without the display, and visual notifications capabilities.



Doctor looking for participants for macular degeneration clinical trial

March 9, 2010

Dr. Ronald Frenkel of the  East Florida Eye Institute is looking for patients with wet macular degeneration to participate in a study.

Frenkel is looking in about a 75-mile radius for additional patients who want to be part of the study. His practice in Stuart specializes in macular degeneration and the clinical trial involves a new form of the drug Lucentis, one of the drugs that doctors hope can halt the progression of wet macular degeneration.

“When the FDA first approved the current Lucentis, it was given monthly, but it was shown that this strength of Lucentis wasn’t as effective when only given four times a year,” Frenkel said. “One of the parts of the test is to see if we use the stronger drug, a ‘super Lucentis’ we can reduce the frequency of the injections.” He said that those who participate in the clinical trial will either get the regular Lucentis or the stronger form of the drug.

Those interested in being evaluated as a possible clinical study participant should call the East Florida Eye Institute at (772) 287-9000.


5 Tops Risk Factors for Macular Degeneration

March 5, 2010

Are you at risk for Age-Related Macular Degeneration?

Here are the top 5 risk factors for AMD:

  • Being over the age of 60
  • Having a family history of AMD
  • Cigarette smoking
  • Obesity
  • Hypertension

If you have any two of these risk factors, you should schedule an appointment with your Eye M.D for a complete evaluation. Your Eye M.D. may recommend certain preventive measures which can reduce your risk of vision loss from this disorder.

People who are at risk should know the symptoms of wet AMD, the form most likely to cause rapid and serious vision loss. These include sudden, noticeable loss or distortion of vision, such as seeing “wavy” lines. See an Eye M.D. right away if these symptoms occur. Current treatments for wet AMD provide an excellent chance of stopping vision loss and may actually restore some vision when macular degeneration develops. Earlier diagnosis of wet AMD gives a better chance of successful treatment.


Frontiers of Medicine – Restoring Sight

March 5, 2010


Challenge: A genetic disease degrades sight in children and blinds them by adulthood.
Radical Cure: Replace the defective genes with healthy ones.
Status: Three to five years to FDA approval

Popular Science article

Jean Bennett, a molecular geneticist at the University of Pennsylvania School of Medicine, has treated a dozen legally blind patients with Leber’s congenital amaurosis, a single-gene defect that prevents the retina from producing the proteins that play a vital role in maintaining the health of the eyes’ light receptors. For most sufferers, vision begins failing in early childhood. Without the treatment, there is no question that they, or any other sufferer of LCA, will eventually go totally blind.

With additional studies, Bennett says that she could have a drug ready in three years that any retinal surgeon could administer to cure LCA. But she’s not stopping there. Only five children born in the U.S. annually have the same type of LCA as Morehouse, but focusing on a rare single-gene defect is a good way to develop a model for treating more common ailments. “Our success shows that this technique is possible,” Bennett says. “We think this could be a platform for a lot of different blinding diseases.” Within the decade, she says, therapies involving similar eye genes could improve sight in people with other mutations, such as retinitis pigmentosa or macular degeneration.

How It Works

A virus carrying copies of the healthy gene is injected near the eye’s retinal-pigment epithelium cells. The virus invades the cells, which convert the new genes into the proteins that supply the rods and cones with the vitamin A necessary to form the pigment that absorbs light and allows a person to see.