Teaching the Chromo4Vis technology to University College London

We are pleased to introduce our proprietary Chromo4Vis technology to University College London’s Institute of Ophthalmology in London, Monday November 6, 2017. 

Marco Lombardo will present the groundbreaking Chromo4Vis technology to UCL scientists and clinicians as the most innovative solution for abating the need of corneal transplantation in people with keratoconus. 

The grand round is a part of the “Imaging seminars” given by the most renowned clinician-scientists at the UCL and Moorfields Eye Hospital. The seminars are broadcasted live at https://www.ucl.ac.uk/live/imaging-seminars

University College London’s Institute of Ophthalmology has been officially named the best place in the world to study ophthalmology by CWUR.
After having raised a lot of enthusiasm in Stanford University in July, the next seminar of Vision Engineering Italy in UCL is the confirmation of the great scientific and clinical interest in Chromo4Vis technology by the most advanced centers of ophthalmic research and teaching in the world.

Vision Engineering Italy - committed to improving human vision through smart solutions.

FDA Approves First Gene Therapy For Leukemia

Scientists have created a treatment in which genetically modified T cells, shown in blue, can attack cancer cells, shown in red.

Steve Gschmeissner/Science Source

The Food and Drug Administration on Wednesday announced what the agency calls a "historic action" — the first approval of a cell-based gene therapy in the United States.

The FDA approved Kymriah, which scientists refer to as a "living drug" because it involves using genetically modified immune cells from patients to attack their cancer.

The drug was approved to treat children and young adults up to age 25 suffering from a form of acute lymphoblastic leukemia who do not respond to standard treatment or have suffered relapses.

The disease is a cancer of blood and bone marrow that is the most common childhood cancer in the United States. About 3,100 patients who are 20 and younger are diagnosed with ALL each year.

"We're entering a new frontier in medical innovation with the ability to reprogram a patient's own cells to attack a deadly cancer," FDA Commissioner Scott Gottlieb said in a written statement.

"New technologies such as gene and cell therapies hold out the potential to transform medicine and create an inflection point in our ability to treat and even cure many intractable illnesses," Gottlieb said.

The treatment involves removing immune system cells known as T cells from each patient and genetically modifying the cells in the laboratory to attack and kill leukemia cells. The genetically modified cells are then infused back into patients. It's also known as CAR-T cell therapy.

"Kymriah is a first-of-its-kind treatment approach that fills an important unmet need for children and young adults with this serious disease," said Peter Marks, director of the FDA's Center for Biologics Evaluation and Research.

"Not only does Kymriah provide these patients with a new treatment option where very limited options existed, but a treatment option that has shown promising remission and survival rates in clinical trials," Marks said in the FDA statement.

The treatment, which is also called CTL019, produced remission within three months in 83 percent of 63 pediatric and young adult patients. The patients had failed to respond to standard treatments or had suffered relapses. Based on those results, an FDA advisory panel recommended the approval in July.

The treatment does carry risks, however, including a dangerous overreaction by the immune system known as cytokine-release syndrome. As a result, the FDA is requiring strong warnings.

In addition, the treatment will be initially available only at 32 hospitals and clinics that have been specially trained in administering the therapy.

Novartis, which developed the drug, says the one-time treatment will cost $475,000 for patients who respond. People who do not respond within a month would not be charged, and the company said it is taking additional steps to make sure everyone who needs the drug can afford it

But some patient advocates criticized the cost nevertheless.

"While Novartis' decision to set a price at $475,000 per treatment may be seen by some as restraint, we believe it is excessive," says David Mitchell, founder and president of Patients For Affordable Drugs. "Let's remember, American taxpayers invested over $200 million in CAR-T's discovery."

Unregulated Stem Cell Treatments Can Be Dangerous

It read like a nightmare excursion through medical tourism. Three women blinded by an unproven “stem cell” treatment. But it didn’t happen in South East Asia, Russia or Eastern Europe. It happened in Florida.

The story was reported in the New England Journal of Medicine. The women in Florida paid $5,000 each for treatment. The clinic was advertising a stem cell treatment for the dry form of age-related macular degeneration. The company was listed on ClinicalTrials.gov, so the women thought they were participating in an approved research trial. But the clinical trials website is simply a registry site of human studies. It does not examine the scientific validity, ethics or safety of a trial. 

The treatment on these three women involved taking fat tissue from their stomach, mixing these “stem cells” with a collection of vaguely defined additives and then injecting it into both of their eyes. The treatment was “off-the-charts dangerous,” said Thomas Albini, MD, the doctor the women saw after experiencing the devastating consequences of the stem cell treatment.

Before the treatment, the women had lost some vision from their disease, but were still able to drive. A week after the treatment, they were legally blind.

There are more unregulated clinics marketing so-called stem cell treatments than ever before. A recent study in Cell Stem Cell estimates that 351 businesses are now operating nearly 600 clinics in the United States.

These clinics have gotten around U.S. Food and Drug Administration (FDA) oversight on a technicality. The clinics take cells from the patient, manipulate them just a little and then inject them back into the patient. The FDA hasn’t been involved because the cells are coming from the same person on whom they are being used.

Ajay Kuriyan, MD, is an ophthalmologist at the University of Miami Hospital. Dr. Kuriyan said he didn’t understand the scope of the problem until he treated one of the injured women.

“I thought of it as a problem in other countries. But it turns out that the U.S. has more of these clinics and they’re using glossy websites with pictures of happy patients to aggressively sell directly to patients,” Dr. Kuriyan said. “They are preying on patients who are looking for answers.”

There are places doing proper stem cell research, with appropriate oversight. Patients need to know the difference.

What to Ask Before a Stem Cell Treatment

Following the stem cell treatment damage, Dr. Albini treated two of the three Florida women at Bascom Palmer Eye Institute. He recommends that patients ask whether the trial they are considering is registered with the FDA.

“All legitimate stems cell research is registered with the FDA through the filing of an Investigational New Drug Application,” Dr. Albini said. “Most of these rogue clinics seems to pride themselves on institutional review board approval."

The board, known as the IRB, is a committee that reviews research in the United States. "IRB approval is not enough," Dr. Albini said. "They have to file with the FDA.”

Another red flag is payment. Most large clinical trials don’t require payment. Some smaller clinical trials may have a minimum cost. Patients may be responsible for their co-pay or a typical out-of-pocket deductible. Anything above and beyond should be viewed more cautiously.

Another way to protect yourself is to simply talk to your doctor, said Sunir Garg, MD, an ophthalmologist at Wills Eye Institute.

“All the physicians I know want what's best for their patients. If a patient finds information about a trial they think might benefit them, they should talk to their doctor about it,” Dr. Garg said. “Many times their doctor will be able to give them some sense about whether it's worthwhile exploring further. An appointment with a prominent group in town or at the local university can also help guide the patient.”

Stem cell-based treatments have been widely reported in the news as true progress is made. Dr. Garg says some of his patients read these promising stories and feel frustrated, that perhaps bureaucracy or some hidden agenda is preventing them from getting a miracle cure.

“What patients don't appreciate is that these trials are all in early-stage development, the retina is extraordinarily complicated, and replacing or augmenting one specific cell type may not do much to improve visual function,” Dr. Garg said.

“I counsel patients that stem cell therapy today is sort of like where heart or kidney transplants were 30 years ago. Yes, people got them done. But they often didn’t work. And there were problems with the techniques and medications used. Decades of hard work and research refined technique to where it is now.”

The American Academy of Ophthalmology wants to reduce or eliminate unlicensed clinics in the United States. In June 2016, the Academy asked the FDA to tighten regulations and increase investigations into treatments given outside of clinical trials.

Women Face Higher Risk of Blindness Than Men

American Academy of Ophthalmology urges women to make eye health a top priority

SAN FRANCISCO — Studies show there is a gender gap in eye disease. Women are more likely than men to suffer from sight-threatening conditions such as age-related macular degeneration (AMD), cataracts, and glaucoma[1]. In support of Healthy Vision Month in May, the American Academy of Ophthalmology reminds women to make vision a top priority.

Women make up 65 percent of AMD cases; 61 percent of glaucoma and cataract patients are women, and 66 percent of blind patients are women[2]. Why the inequity? There are a few theories. On average women live longer and many eye problems are age-related. Some eye conditions, such as dry eye, are more common in women, young and old. Social and economic factors affect women’s access to eye care, especially in developing countries.

Whatever the cause, there are a few unique vision problems women need to watch out for more than men. Dry eye occurs at double the rate in postmenopausal women[3]. In general, women are more susceptible to autoimmune diseases than men, many of which affect vision, such as lupus, Sjögren’s syndrome and hyperthyroiditis. Also, pregnancy can cause vision changes due to the hormones pregnant women experience. 

Good news is most vision loss is preventable. The Academy offers five simple steps to take control of your eye health today: 

• Get a comprehensive medical eye exam at age 40. Early signs of disease or changes in vision may begin at this age. An exam by an ophthalmologist – a physician who specializes in medical and surgical eye care – is an opportunity to carefully examine the eye for diseases and conditions that may have no symptoms in the early stages.

• Know your family history. Certain eye diseases can be inherited. If you have a close relative with macular degeneration, you have a 50 percent chance of developing this condition. A family history of glaucoma increases your glaucoma risk by four to nine times. Talk to family members about their eye conditions. It can help you and your ophthalmologist evaluate your risk.

• Eat healthy foods. A diet low in fat and rich in fruits, vegetables, and whole grains, benefits the entire body, including the eyes. Eye-healthy food choices include citrus fruits, vegetable oils, nuts, whole grains, dark green leafy vegetables and cold water fish.

• Stop smoking. Smoking increases the risk for eye diseases such as cataract and age-related macular degeneration. Smoking also raises the risk for cardiovascular diseases which can indirectly influence your eye health. Tobacco smoke, including second-hand smoke, also worsens dry eye.
• Wear sunglasses. Exposure to ultraviolet UV light raises the risk of eye diseases, including cataract, fleshy growths on the eye and cancer. Always wear sunglasses with 100 percent UV protection and a hat while enjoying time outdoors.

“Eye exams aren’t only about checking a person's visual acuity or sharpness, but also determining the overall health of their eyes,” said Rebecca J. Taylor, M.D., clinical spokesperson for the American Academy of Ophthalmology. “We encourage women as well as men to get regular eye care. By making vision a priority today, we can help protect our sight as we age.”

To learn more ways to keep your eyes healthy, visit the American Academy of Ophthalmology’s EyeSmart^® website.