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MAY 2017    A Monthly Review of Articles of Interest for the Clinical Community

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<This Month's Clinical Focus:>

<OPHTHALMOLOGY>

 

New Eye Test Could Prevent Millions from Going Blind


A new eye test could prevent glaucoma, the biggest cause of irreversible blindness, by spotting symptoms before loss of sight begins.

Researchers at University College London (UCL) have developed an eye exam that could detect individual nerve cell death at the back of the eye a decade before symptoms present themselves.

Eyeball by Rafael Rezende at FreeImages

Glaucoma affects 16 million people worldwide, many of whom have lost a third of their vision before they start treatment. The disease causes changes to the pressure inside the eye which kills the retina’s nerve cells.  Early detection would allow doctors to start treatment before the patient begins to go blind. The new test uses a fluorescent dye that sticks to cells that are about to die. White fluorescent dots on the retina would reveal whether the patient has early-onset glaucoma.

The test could also diagnose early-onset degenerative neurological conditions, such as Parkinson’s, Alzheimer’s and multiple sclerosis.  The exam is still in its first trial phase and has so far only been tested on 16 people, but the initial results are promising, according to the study published in the medical journal Brain.

“For the first time, we have been able to show individual cell death and detect the earliest signs of glaucoma. While we cannot cure the disease, our test means treatment can start before symptoms begin,” lead researcher Professor Francesca Cordeiro of the UCL Institute of Ophthalmology said in a release published alongside the study.

Bethan Hughes, a spokesperson for the medical charity Wellcome Trust which funded the research, said: “This innovation has the potential to transform lives for those who suffer loss of sight through glaucoma, and offers hope of a breakthrough in early diagnosis of other neurodegenerative diseases.”


by Isabelle Gerretsen, Reprinted with permission from Newsweek via RePubHub
 


Allergan Granted Marketing Authorization by the FDA for TrueTear(TM)

 

First-of-its-Kind Product -- the First Intranasal Neurostimulating Device Proven to Temporarily Increase Tear Production.

PRNewsfoto-Allergan TrueTearTrueTear ™ Intranasal Tear Neurostimulator, the first and only FDA-cleared device developed to temporarily increase tear production during neurostimulation in adult patients.

TrueTear™ is a handheld stimulator with daily disposable tips that is inserted into the nasal cavity to induce the production of tears. There have been two clinical studies showing positive safety and effectiveness of the device in the increase of tear production completed with 145 aqueous deficient dry eye adult patients.

"TrueTear™ represents a technological breakthrough for eye care professionals as it delivers an effective, non-invasive and drug-free way to temporarily increase tear production," said David Nicholson, Chief R&D Officer, at Allergan. "As an innovator in eye care, we are continually looking for new products to offer through our portfolio, and TrueTear™ represents the next step forward."

The new advancement is an addition to Allergan's current eye care portfolio. Last May, Allergan announced positive results from two pivotal trials for TrueTear™ that showed an increase in tear production upon nasal neurostimulation in adults with aqueous tear deficiency. 

"In clinical trials, TrueTear™ demonstrated increased tear production upon stimulation of the nasal cavity," said John Sheppard, M.D., M.M. Sc., professor of Ophthalmology, Eastern Virginia Medical School and president of Virginia Eye Consultants. "Interestingly, neurostimulation has been used as an approach for a wide variety of disorders for more than 30 years. TrueTear™ is the first of its kind to provide a temporary increase in tear production in this way."
 
About the Studies
Study 1 is a prospective, randomized, controlled, double-masked, multicenter, cross-over trial in which participants used an active device and two control applications. The primary effectiveness endpoint of increased tear production during intranasal application as measured by Schirmer score compared to both controls was met. Study 2 is a prospective, single-arm, multicenter, open-label clinical trial in which participants used TrueTear™ to stimulate tear production for 180 days. The primary effectiveness endpoint of increased tear production as measured by Schirmer score during application of the device compared with basal Schirmer score at Day 180 was met.  Secondary endpoints of increased tear production as measured by Schirmer score during application of the device compared with basal Schirmer score at Days 0, 7, 30 and 90 were also met. The direct clinical benefit of temporarily increasing tear production as a therapy for patients with dry eye disease was not assessed as part of these clinical trials.  All device-related adverse events were mild in nature. There were no device-related serious adverse events.


Displayed with permission from PR Newswire via RePubHub


Image credits: Eye by Raphael Rezende provided by CC0 license from FreeImages.com and Allergan via PRNewswire and RePubHub


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