The outcome from LEAD trial is another key growth corridor for Ellex, on top of itrack or its core lasers.
1. Latest update is coming soon.
"Commercialisation of Ellex 2RT® is pending the outcome of the Laser intervention in Early Age Related Macular Degeneration (LEAD) clinical trial. The results of this trial are anticipated during the quarter ending 30 September 2018."
2. One study early this year showed "Subthreshold, nanosecond pulsed laser treatment shows promise as a treatment for age-related macular degeneration (AMD); however, the safety profile needs to be robustly examined. The aim of this study was to investigate the effects of laser treatment in humans and mice." https://www.ncbi.nlm.nih.gov/pubmed/29392319
3. There is no treatment for early AMD, until they progressed to more advanced stages.
4. According to https://nei.nih.gov/eyedata/amd, by the age of 74, 2% of "white" population will experience AMD, by age of 79, the prevalence rate doubles to 4%. For 80+, 14% experience AMD.
5. The opportunity to early AMD treatment start as early as when population approach age of 70. This is particularly, significant in global aging population trends.
E.g. in US, the number of Americans ages 65 and older is projected to more than double from 46 million today to over 98 million by 2060.
In Australia, In 2016, there were 3.7 million (15%) Australians aged 65. The number and proportion of older Australians is expected to continue to grow. By 2056, it is projected there will be 8.7 million older Australians (22% of the population); by 2096, 12.8 million people (25%) will be aged 65 years and over.
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Here's some facts:
What is AMD?
AMD is a common eye condition and a leading cause of vision loss among people age 50 and older. It causes damage to the macula, a small spot near the center of the retina and the part of the eye needed for sharp, central vision, which lets us see objects that are straight ahead.
In some people, AMD advances so slowly that vision loss does not occur for a long time. In others, the disease progresses faster and may lead to a loss of vision in one or both eyes. As AMD progresses, a blurred area near the center of vision is a common symptom. Over time, the blurred area may grow larger or you may develop blank spots in your central vision. Objects also may not appear to be as bright as they used to be.
AMD by itself does not lead to complete blindness, with no ability to see. However, the loss of central vision in AMD can interfere with simple everyday activities, such as the ability to see faces, drive, read, write, or do close work, such as cooking or fixing things around the house.
What are the stages of AMD?
There are three stages of AMD defined in part by the size and number of drusen under the retina. It is possible to have AMD in one eye only, or to have one eye with a later stage of AMD than the other.
Early AMD. Early AMD is diagnosed by the presence of medium-sized drusen, which are about the width of an average human hair. People with early AMD typically do not have vision loss.
Intermediate AMD. People with intermediate AMD typically have large drusen, pigment changes in the retina, or both. Again, these changes can only be detected during an eye exam. Intermediate AMD may cause some vision loss, but most people will not experience any symptoms.
Late AMD. In addition to drusen, people with late AMD have vision loss from damage to the macula. There are two types of late AMD:
In geographic atrophy (also called dry AMD), there is a gradual breakdown of the light-sensitive cells in the macula that convey visual information to the brain, and of the supporting tissue beneath the macula. These changes cause vision loss.
In neovascular AMD (also called wet AMD), abnormal blood vessels grow underneath the retina. (“Neovascular” literally means “new vessels.”) These vessels can leak fluid and blood, which may lead to swelling and damage of the macula. The damage may be rapid and severe, unlike the more gradual course of geographic atrophy. It is possible to have both geographic atrophy and neovascular AMD in the same eye, and either condition can appear first.
Early AMD
Currently, no treatment exists for early AMD, which in many people shows no symptoms or loss of vision. Your eye care professional may recommend that you get a comprehensive dilated eye exam at least once a year. The exam will help determine if your condition is advancing.
As for prevention, AMD occurs less often in people who exercise, avoid smoking, and eat nutritious foods including green leafy vegetables and fish. If you already have AMD, adopting some of these habits may help you keep your vision longer.
Intermediate and late AMD
Researchers at the National Eye Institute tested whether taking nutritional supplements could protect against AMD in the Age-Related Eye Disease Studies (AREDS and AREDS2). They found that daily intake of certain high-dose vitamins and minerals can slow progression of the disease in people who have intermediate AMD, and those who have late AMD in one eye.
The first AREDS trial showed that a combination of vitamin C, vitamin E, beta-carotene, zinc, and copper can reduce the risk of late AMD by 25 percent. The AREDS2 trial tested whether this formulation could be improved by adding lutein, zeaxanthin or omega-3 fatty acids. Omega-3 fatty acids are nutrients enriched in fish oils. Lutein, zeaxanthin and beta-carotene all belong to the same family of vitamins, and are abundant in green leafy vegetables.
The AREDS2 trial found that adding lutein and zeaxanthin or omega-three fatty acids to the original AREDS formulation (with beta-carotene) had no overall effect on the risk of late AMD. However, the trial also found that replacing beta-carotene with a 5-to-1 mixture of lutein and zeaxanthin may help further reduce the risk of late AMD. Moreover, while beta-carotene has been linked to an increased risk of lung cancer in current and former smokers, lutein and zeaxanthin appear to be safe regardless of smoking status.
Here are the ingredients based on AREDS and AREDS2 research:
500 milligrams (mg) of vitamin C
400 international units of vitamin E
80 mg zinc as zinc oxide
2 mg copper as cupric oxide
10 mg lutein and 2 mg zeaxanthin
If you have intermediate or late AMD, you might benefit from taking supplements containing these ingredients. But first, be sure to review and compare the labels. Many supplements have different ingredients, or different doses, from those tested in the AREDS trials. Also, consult your doctor or eye care professional about which supplement, if any, is right for you. For example, if you smoke regularly, or used to, your doctor may recommend that you avoid supplements containing beta-carotene.
Even if you take a daily multivitamin, you should consider taking an AREDS supplement if you are at risk for late AMD. The formulations tested in the AREDS trials contain much higher doses of vitamins and minerals than what is found in multivitamins. Tell your doctor or eye care professional about any multivitamins you are taking when you are discussing possible AREDS formulations.
You may see claims that your specific genetic makeup (genotype) can influence how you will respond to AREDS supplements. Some recent studies have claimed that, depending on genotype, some patients will benefit from AREDS supplements and others could be harmed. These claims are based on a portion of data from the AREDS research. NEI investigators have done comprehensive analyses of the complete AREDS data. Their findings to date indicate that AREDS supplements are beneficial for patients of all tested genotypes. Based on the overall data, the American Academy of Ophthalmology (link is external) does not support the use of genetic testing to guide treatment for AMD.
Finally, remember that the AREDS formulation is not a cure. It does not help people with early AMD, and will not restore vision already lost from AMD. But it may delay the onset of late AMD. It also may help slow vision loss in people who already have late AMD.
Advanced neovascular AMD
Neovascular AMD typically results in severe vision loss. However, eye care professionals can try different therapies to stop further vision loss. You should remember that the therapies described below are not a cure. The condition may progress even with treatment.
Injections. One option to slow the progression of neovascular AMD is to inject drugs into the eye. With neovascular AMD, abnormally high levels of vascular endothelial growth factor (VEGF) are secreted in your eyes. VEGF is a protein that promotes the growth of new abnormal blood vessels. Anti-VEGF injection therapy blocks this growth. If you get this treatment, you may need multiple monthly injections. Before each injection, your eye will be numbed and cleaned with antiseptics. To further reduce the risk of infection, you may be prescribed antibiotic drops. A few different anti-VEGF drugs are available. They vary in cost and in how often they need to be injected, so you may wish to discuss these issues with your eye care professional.
Photodynamic therapy. This technique involves laser treatment of select areas of the retina. First, a drug called verteporfin will be injected into a vein in your arm. The drug travels through the blood vessels in your body, and is absorbed by new, growing blood vessels. Your eye care professional then shines a laser beam into your eye to activate the drug in the new abnormal blood vessels, while sparing normal ones. Once activated, the drug closes off the new blood vessels, slows their growth, and slows the rate of vision loss. This procedure is less common than anti-VEGF injections, and is often used in combination with them for specific types of neovascular AMD.
Laser surgery. Eye care professionals treat certain cases of neovascular AMD with laser surgery, though this is less common than other treatments. It involves aiming an intense “hot” laser at the abnormal blood vessels in your eyes to destroy them. This laser is not the same one used in photodynamic therapy which may be referred to as a “cold” laser. This treatment is more likely to be used when blood vessel growth is limited to a compact area in your eye, away from the center of the macula, that can be easily targeted with the laser. Even so, laser treatment also may destroy some surrounding healthy tissue. This often results in a small blind spot where the laser has scarred the retina. In some cases, vision immediately after the surgery may be worse than it was before. But the surgery may also help prevent more severe vision loss from occurring years later.
2010 Prevalence Rates of AMD by Race
White Americans have the greatest likelihood of developing AMD. In 2010, 2.5 percent of white adults age 50 and older had AMD. By comparison, AMD affected 0.9 percent each of blacks, Hispanics and people of other races. Table for 2010 Prevalence Rates of AMD by Race
2010 U.S. Prevalent Cases of AMD (in thousands) by Age, and Race/Ethnicity
The majority of AMD cases occur among white Americans. In 2010, 89 percent of Americans with AMD were white. By comparison, black and Hispanic American populations each accounted for four percent of AMD cases. Table for 2010 U.S. Prevalent Cases of AMD (in thousands) by Age, and Race/Ethnicity
2010 U.S. Prevalent Cases of AMD (in thousands) by Age, Gender, and Race/Ethnicity
Women generally have a longer life expectancy than men and are therefore more likely to develop age-related eye diseases such as AMD. In 2010, 65 percent of AMD cases were in women compared with 35 percent in men. Table for 2010 U.S. Prevalent Cases of AMD (in thousands) by Age, Gender, and Race/Ethnicity
Projections for AMD (2010-2030-2050)
By 2050, the estimated number of people with AMD is expected to more than double from 2.07 million to 5.44 million. White Americans will continue to account for the majority of cases. However, Hispanics will see the greatest rate of increase, with a nearly six-fold rise in the number of expected cases from 2010 to 2050. Table for Projections for AMD (2010-2030-2050)
Changes of Cases between 2000 and 2010
As the proportion of people in the U.S. age 65 and older grows larger, more people are developing age-related diseases such as AMD. From 2000-2010, the number of people with AMD grew 18 percent, from 1.75 million to 2.07 million. Table for Changes of Cases between 2000 and 2010
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