First-of-its-kind corneal implant to improve near vision in certain patients

April 17, 2015
The U.S. Food and Drug Administration today approved the KAMRA inlay, a device implanted in the cornea of one eye (the clear, front surface) to improve near vision in certain patients with presbyopia. It is the first implantable device for correction of near vision in patients who have not had cataract surgery.

Presbyopia is the loss of the ability to change the focusing power of the eye. It occurs with normal aging and results in difficulty with near vision, generally in adults 40 to 50 years of age. The KAMRA inlay is an opaque, ring-shaped device intended for use in patients 45 to 60 years old who, in addition to not having had cataract surgery, are unable to focus clearly on near objects or small print and need reading glasses with +1.00 to +2.50 diopters of power—but do not need glasses or contacts for clear distance vision.

“Presbyopia is a natural part of aging and can make reading and performing close-up work difficult,” said William Maisel, M.D., deputy center director for science in the FDA’s Center for Devices and Radiological Health. “The KAMRA inlay provides a new option for correcting near vision in certain patients.”

The device works by blocking unfocused light rays entering the eye in order to improve near vision. It blocks peripheral light rays while allowing central light rays to pass through a small opening in the center of the device, making near objects and small print less blurry.

To insert the device, an eye surgeon uses a laser to create a pocket in the cornea of one eye of the patient and implants the device in that pocket. This is intended to allow the patient to have improved near vision in the eye containing the implant, while not affecting the distance vision of the two eyes working together.

To evaluate the safety and efficacy of the KAMRA inlay, the FDA reviewed the results of three clinical studies. The results of the main study showed that 83.5 percent of the evaluable 478 participants achieved uncorrected near visual acuity of 20/40 or better at 12 months. This is the level of vision needed to read most text in magazines and newspapers.

The device is not intended for patients who have had cataract surgery or patients with severe dry eye; an active eye infection or inflammation; corneal abnormalities related to thinning and irregular shape of the surface of their eyes; insufficient corneal thickness to withstand the procedure; a recent or recurring herpes eye infection or problems resulting from past infection; uncontrolled glaucoma; uncontrolled diabetes; or active autoimmune or connective tissue disease.

The labeling warns that the device’s safety and effectiveness in patients who have had LASIK or other refractive procedures is unknown.

The KAMRA inlay may cause or worsen dry eye and various vision-related problems, such as glare, halos, night vision problems, and blurry vision. It also can cause corneal complications such as swelling, clouding, thinning and potential perforation, and challenges evaluating and managing eye problems. For patients experiencing vision problems after the surgery, removal of the device may improve vision in some cases. In other cases, decreased vision could become permanent. There is also a potential risk for the focusing power of the eye to change, causing blurry vision and requiring glasses.

Long naps and daytime sleepiness could increase risk of diabetes

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18 September 2015

Excessive daytime sleepiness and long naps can signal many things, from working late to sleep disturbance. According to a new study, however, daytime sleepiness and taking long naps may both also be associated with an increased risk of type 2 diabetes.

The research is presented at the 51st Annual Meeting of the European Association for the Study of Diabetes, taking place in Stockholm, Sweden.

Getting enough sleep is a key part of a healthy lifestyle, playing a crucial role in protecting both physical and mental health. Not getting enough sleep can lead to sleepiness during the day along with napping – the habit of taking short sleeps ranging from a few minutes to a few hours.

According to the National Sleep Foundation, a short nap of 20-30 minutes can help improve mood, alertness and performance. However, napping for longer than 10-20 minutes can lead to sleep inertia – a feeling of disorientation that comes from waking after a deep sleep – as well as potentially having a negative effect on the length and quality of nighttime sleep.

In the new study, Dr. Tomohide Yamada, of the University of Tokyo, Japan, and colleagues set out to examine the association between daytime sleepiness, napping and the risk of type 2 diabetes by conducting a meta-analysis of research published up to November 2014.

Many of the risk factors for type 2 diabetes are linked to lifestyle, including physical inactivity, excess weight and poor diet.
Excessive sleepiness linked to 56% increase in type 2 diabetes risk

The researchers identified 10 studies that were suitable for the meta-analysis, involving a total of 261,365 subjects. These studies utilized self-reporting to determine daytime sleepiness and napping, with questions such as “Do you have a problem with sleepiness during the daytime?” to measure the participants’ sleep habits.

Risk of type 2 diabetes increased by 56% among those who reported excessive daytime sleepiness. While napping for longer than 60 minutes during the day increased the risk of type 2 diabetes by 46%, naps that were shorter than this did not affect diabetes risk.

“Excessive daytime sleepiness and taking longer naps were associated with increased risk of type 2 diabetes, with a short nap not increasing this risk,” the authors conclude.

Regarding these findings, the authors suggest that mechanisms behind short naps – demonstrated in several studies to have beneficial effects – could explain things, stating that short naps finish before the onset of deep slow-wave sleep:

“Entering deep slow-wave sleep and then failing to complete the normal sleep cycle can result in a phenomenon known as sleep inertia, in which a person feels groggy, disoriented, and even sleepier than before napping. Although the mechanisms by which a short nap might decrease the risk of diabetes are still unclear, such duration-dependent differences in the effects of sleep might partly explain our findings.”

The researchers also point out that daytime napping could be caused by nighttime sleep disturbance such as obstructive sleep apnea. This condition is associated with ischemia, stroke, cardiovascular events and all-cause mortality, and also shares some risk factors with type 2 diabetes, such as excess weight and age.

Probiotic formula may hold key to cows milk allergy

23 September 2015
Food allergies are growing in prevalence in developed countries, and 3% of children globally are allergic to cow’s milk. New research carried out on children with cow’s milk allergy has shown that structural differences in gut bacteria may be the reason why some children do not acquire tolerance.

Teams from the University of Chicago, IL, Argonne National Laboratory in Lemont, IL, and the University of Naples Federico II in Italy found that some infants gained tolerance to cow’s milk after being treated with probiotic formula, while others did not.

The Centers for Disease Control and Prevention (CDC) name allergies as the sixth leading cause of chronic illness in the US, affecting more than 50 million Americans and costing more than $18 billion annually in health care. In a study released by the CDC in 2013, food allergies among children increased by 18% from 1997 to 2007 and by 50% between 1997 and 2011.

The National Institute of Allergy and Infectious Diseases note that allergy to cow’s milk is common in infants and young children and can develop within days to months after birth. Symptoms include abdominal pain, hives and eczema, or colic and sleeplessness, as well as blood in the stool and poor growth, depending on the type of immune response involved.

It seems increasingly likely that modern environmental influences, including widespread antibiotic use, high-fat and low-fiber diets, reduced exposure to infectious diseases, Cesarean birth and formula feeding are factors.

These are believed to have altered the mutually beneficial relationship between humans and the bacteria that live in the gastrointestinal tract. This dysbiosis, or distorting of the structure of the microbial community, can cause allergies in those who are genetically prone to developing them.

In previous research, Roberto Berni Canani and colleagues from the University of Naples studied the reaction of infants with cow’s milk allergy to probiotic and nonprobiotic formula. One group was given a formula containing a form of the milk protein casein, supplemented with the probiotic bacterial species Lactobacillus rhamnosus GG (LGG). The other group was treated with a nonprobiotic formula.
Those who took the probiotic formula developed a higher level of tolerance, suggesting that probiotic formula is more helpful in overcoming cow’s milk allergy.

Dr. Nagler and her team identified a common class of mucus-associated gut bacteria that are instrumental in regulating how dietary allergens reach the bloodstream. They now believe that the way commensal bacteria regulate allergic responses to food may be different than what was previously thought.

The findings suggest that certain bacteria make children more likely to develop tolerance, and that tolerance is linked to the acquisition of specific strains of bacteria, including Blautia and Coprococcus, which produce butyrate.

Jack Gilbert, PhD, associate professor in the Department of Ecology & Evolution at the University of Chicago, group leader for microbial ecology at Argonne National Laboratory and co-author of the study, says:

“The ability to identify bacterial strains that could be developed as a way to therapeutics for treating food allergies is a fundamental advance. Translating these findings into clinical treatments is our next goal.”

Breast cancer relapse could be predicted with new blood test

27 August 2015
A test that identifies genetic information in the blood picks up sensitive amounts of DNA that can be used to shape decisions about cancer treatment.

One of the challenges of modern medicine is to know if and when a cancer patient will relapse. A new study shows that months before tumors are visible on hospital scans, a “mutation-tracking” blood test can pick up valuable signs of a cancer’s return.

The study, undertaken by researchers at The Institute of Cancer Research (ICR) and The Royal Marsden NHS Foundation Trust – both in the UK – is an important step toward changing the way cancer is monitored in the clinic and informing treatment decisions.

The clue to identifying a return of cancer cells is to look at circulating tumor DNA present in the blood. These are cancer cells left behind that may seed new tumors even after treatment.

By monitoring patients with blood tests taken after surgery, the study says, and then every 6 months in follow-up, the researchers were able to predict very accurately who would experience a relapse.

The study involved 55 women who had been successfully treated for early-stage breast cancer.
It was found those who tested positive for circulating tumor DNA were at 12 times greater risk of relapse compared with those who tested negative. In addition, the blood test was able to detect cancer recurrence an average of 7.9 months before any visible signs appeared.

Explaining what the researchers are attempting to achieve with the blood test, Kat Arney, science information manager at Cancer Research UK, told BBC Radio:

“They are looking for ways to detect DNA that has been shed by tumor cells into the bloodstream and saying can we use this DNA as a way of monitoring if the cancer is coming back – how it is changing, how it is evolving in the body – and then could we use that to monitor cancer and pick up potentially when it has come back without having to give scans or biopsies.”

“There are still challenges in implementing this technology […] but the information that it provides could make a real difference to breast cancer patients, ” added Dr. Nicholas Turner, team leader in molecular oncology at ICR and consultant medical oncologist at The Royal Marsden.
Findings could be applied to all breast cancer subtypes

Because the researchers were searching for mutations common to various breast cancer types, they found the test could be applied to all subtypes of the disease.

“This test could help us stay a step ahead of cancer by monitoring the way it is changing and picking treatments that exploit the weakness of the particular tumor, ” says Prof. Paul Workman, chief executive at ICR.

The potential of this new test, Arney told BBC Radio, is to “separate those mutations that are driving the cancer from all the other genetic chaos that is going on in there, looking at how we can target these particular gene faults in this particular person, and those are the same faulty genes that are driving their relapse when the cancer comes back.”

Researchers create antimicrobial biofilm to protect medical implants from infection

24 September 2015
Countless lives have been prolonged and improved with medical implants like pacemakers and replacement hips. But such operations also carry the risk that infection-causing microbes may grow on the implant and the immune system may reject the foreign object.

Despite having several layers, the new biofilm is only a few hundred nanometers thick and invisible to the naked eye.

Now, an Inserm team from Strasbourg University in France has succeeded in creating a biofilm that protects against such infection.

The biomaterials and bioengineering researchers describe their work in the journal Advanced Healthcare Materials.

Inserm (Institut national de la santé et de la recherche médicale) is a national biomedical and public health research institution that is mostly based in French hospitals and universities.

The extremely thin, silver-coated biofilm has antimicrobial, antifungal and anti-inflammatory properties and can be used to cover titanium implants – including new hips, prostheses and pacemakers, and other medical devices that can cause infection, such as catheters.

The team has performed various tests on the new film and found it reduces inflammation and prevents the most common bacterial and fungal infections.

They showed that when an implant coated with the film comes into contact with human blood, the film prevents immune cells from triggering inflammatory markers.

Senior author Dr. Philippe Lavalle, research director at Inserm, says they also found that “the film inhibits the growth and long-term proliferation of staphylococcal bacteria (Staphylococcus aureus), yeast strains (Candida albicans) or fungi (Aspegillus fumigatus) that frequently cause implant-related infection.”

The team expects the film will be available for use in a few years.
An effective alternative to antibiotics

Implantable medical devices provide an ideal surface for microbial colonies. This can lead to infection and inflammation and rejection of the implant.

Currently, antibiotics are used to reduce the risk of such infections, but the growth of drug-resistant microbes is making them less effective.

Despite having several layers, the new biofilm is only a few hundred nanometers thick and invisible to the naked eye. It comprises two substances: polyarginine and hyaluronic acid.

The polyarginine causes the immune system to suppress its anti-inflammatory response, and the hyaluronic acid, which occurs naturally in the body and is compatible with it, inhibits bacterial growth.

The film is also embedded with natural antimicrobial peptides, including catestatin. These are not only very effective against microbes – they kill them by punching holes in their cell walls and blocking any counter-moves – they are nontoxic to the body.

Another important feature of the biofilm is its silver lining. This prolongs its antimicrobial activity, as Dr. Lavalle explains:

“Silver is an anti-infectious material currently used on catheters and dressings. This strategy allows us to extend antimicrobial activity in the long term.”

Capsaicin Patch Approved in EU for Diabetic Neuropathy Pain

September 21, 2015

Patients with diabetic peripheral neuropathy who used a capsaicin 8% patch (Qutenza, Astellas Pharma) had more relief from pain and better sleep quality than those who received a placebo patch, according to a phase 3 study reported at the European Association for the Study of Diabetes (EASD) 2015 Meeting.

The results were presented as the company announced the patch has just been approved in Europe for the additional indication of the treatment of adult diabetes patients with peripheral neuropathic pain, either alone or in combination with other medicinal products for pain.

The capsaicin patch is already approved for use in the European Union for neuropathic pain, but that license excluded patients with diabetes. Similarly, in the United States, the capsaicin patch is approved for the treatment of postherpetic neuralgia, but this label doesn’t include diabetes patients.

At the EASD meeting, Malcolm Stoker, PhD, global medical lead at Astellas Pharma Global Development, the Netherlands, presented the findings of the randomized, placebo-controlled, double-blind STEP trial assessed the efficacy and safety of the patch, a dermal delivery system containing 8% capsaicin, vs placebo, following patients for 12 weeks

“We found that capsaicin 8% patch provides a statistically significant improvement in pain relief and sleep quality compared with placebo in these patients,” said Dr Stoker. The capsaicin patch “was well-tolerated, and safety was consistent with previous studies in postherpetic neuralgia and HIV-associated neuropathy.”

“The most commonly reported treatment-emergent adverse events were burning sensation [14% capsaicin, 2.7% placebo]; unsurprisingly, pain in extremity [10.8% vs 5.5%]; and application-site pain. There were no serious adverse events or deaths in either group,” Dr Stoker reported.

In conclusion, he added that the study extends the range of peripheral neuropathic pain etiologies for which the capsaicin 8% patch shows efficacy and safety.

Female Viagra Flibanserin (Addyi)

August 18, 2015

After a long and controversial process, the US Food and Drug Administration (FDA) has approved the first-ever drug aimed at boosting female libido.

“Today’s approval provides women distressed by their low sexual desire with an approved treatment option,” said Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, in a statement.

Flibanserin (Addyi) — also known as “Female Viagra” or “Pink Viagra” — will be marketed by Sprout Pharmaceuticals. It is approved to treat premenopausal women. The nonhormonal therapy — a 5-hydroxytryptophan (HT)(1A) receptor agonist and 5-HT(2A) receptor antagonist — was approved for hypoactive sexual desire disorder (HSDD). The HSDD diagnosis appeared in the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-4), but was subsumed into a larger category of Female Sexual Interest/Arousal Disorder in the latest edition, DSM-5.

The once-daily 100-milligram tablet is to be taken at bedtime, and alcohol use will be contraindicated due to common side effects including drowsiness and dizziness. The label will include a boxed warning about the potential for increased hypotension or syncope with alcohol. The FDA is requiring Sprout to conduct three postmarketing studies in patients to better understand the interaction between flibanserin and alcohol. Concomitant use with moderate-to-strong CYP3A4 inhibitors — such as antifungals — will also be contraindicated and included in the boxed warning.

“HSDD is a very real problem for women,” Leah Millheiser, MD, director of the female sexual medical program at Stanford University School of Medicine, told Medscape Medical News. Dr Millheiser said that the condition is caused by an imbalance in neurotransmitters, and that “there is absolutely a need for a drug that’s been shown to be safe and effective.”

New device to help the blind process visual signals via their tongues

June 18, 2015
The Food and Drug Administration today allowed marketing of a new device that when used along with other assistive devices, like a cane or guide dog, can help orient people who are blind by helping them process visual images with their tongues.

The BrainPort V100 is a battery-powered device that includes a video camera mounted on a pair of glasses and a small, flat intra-oral device containing a series of electrodes that the user holds against their tongue. Software converts the image captured by the video camera in to electrical signals that are then sent to the intra-oral device and perceived as vibrations or tingling on the user’s tongue. With training and experience, the user learns to interpret the signals to determine the location, position, size, and shape of objects, and to determine if objects are moving or stationary.

“Medical device innovations like this have the potential to help millions of people,” said William Maisel, M.D., M.P.H., deputy director for science and chief scientist in the FDA’s Center for Devices and Radiological Health. “It is important we continue advancing device technology to help blind Americans live better, more independent lives.”

Non-surgical temporary balloon device to treat obesity

July 28, 2015
The U.S. Food and Drug Administration today approved a new balloon device to treat obesity without the need for invasive surgery. The ReShape Integrated Dual Balloon System (ReShape Dual Balloon) is intended to facilitate weight loss in obese adult patients. The device likely works by occupying space in the stomach, which may trigger feelings of fullness, or by other mechanisms that are not yet understood.

The ReShape Dual Balloon device is delivered into the stomach via the mouth through a minimally invasive endoscopic procedure. The outpatient procedure usually takes less than 30 minutes while a patient is under mild sedation. Once in place, the balloon device is inflated with a sterile solution, which takes up room in the stomach.

The device does not change or alter the stomach’s natural anatomy. Patients are advised to follow a medically supervised diet and exercise plan to augment their weight loss efforts while using the ReShape Dual Balloon and to maintain their weight loss following its removal. It is meant to be temporary and should be removed six months after it is inserted.

“For those with obesity, significant weight loss and maintenance of that weight loss often requires a combination of solutions including efforts to improve diet and exercise habits,” said William Maisel, M.D., M.P.H., acting director of the Office of Device Evaluation at the FDA’s Center for Devices and Radiological Health. “This new balloon device provides doctors and patients with a new non-surgical option that can be quickly implanted, is non-permanent, and can be easily removed.”

The ReShape Dual Balloon is indicated for weight reduction in obese adult patients with a body mass index (BMI) of 30 to 40 kg/m2. The device is limited to patients with one or more obesity-related conditions such as high blood pressure, high cholesterol, and diabetes. It is intended for patients who have failed previous attempts at weight loss through diet and exercise alone.

There are currently three other FDA-approved devices to treat morbid obesity: the Allergan LAP-Band the Ethicon Endo-Surgery Realize Adjustable Gastric Band and the Maestro Rechargeable System.

ACIP Changes Pneumococcal Vaccine Interval in Low-Risk Elderly

September 04, 2015
The Advisory Committee on Immunization Practices (ACIP) has revised its interval recommendations for the pneumococcal polysaccharide vaccine (PPSV23) and pneumococcal conjugate vaccine (PCV13) in older healthy adults.

Specifically, immunocompetent adults older than 65 years who have not previously been vaccinated with pneumococcal vaccine should receive a dose of PCV13, followed at least 1 year later by a dose of PPSV23, according to the updated guidelines, published in the September 4 issue of the Morbidity and Mortality Weekly Report. If PPSV23 is given earlier than the recommended interval, the dose need not be repeated, the guidelines specify.

“No clinical studies evaluating efficacy of the two vaccines given in series are available. Therefore, current recommendations are based on best available evidence from immunogenicity studies,” the authors write.

In its previous guidelines published in 2014, the ACIP recommended routine use of a dose of PCV13 followed 6 to 12 months later by a dose of PPSV23. The change harmonizes the vaccine interval in this patient population with that recommended for immunocompetent adults older than 65 years who already received a dose of PPSV23. For adults in the latter group, the guidelines are unchanged: They should receive a dose of PCV13 at least 1 year after receiving the PPSV23, according to the report.

The revision is supported by studies of PCV–PPSV23 sequence among immunocompetent adults suggesting that shorter between-dose intervals may be associated with increased local reactogenicity when compared with longer intervals, whereas intervals of at least 1 year may lead to an improved immune response against serotypes in both vaccines compared with a single dose of either, the authors write.

The vaccine interval recommendations for other patient populations remain unchanged from the existing guidelines. In particular, a dose of PPSV23 should be given at least 8 weeks after a dose of PCV13 in children and adults at high risk for pneumococcal disease, including those with an immunocompromising condition, functional or anatomic asplenia, cerebrospinal fluid leak, or cochlear implant.

“The currently recommended 8-week interval minimizes the risk window for invasive pneumococcal disease caused by serotypes unique to PPSV23 in these highly vulnerable groups,” the authors write.

Children with an immunocompromising condition or functional or anatomic asplenia should receive a second dose of PPSV23 5 years after the first PPSV23, according to the guidelines.