Food and drug administration Committee recommends gene therapy for retinal disease to assist prevent blindness

Within an encouraging sign for Spark Therapeutics, a U.S. Fda Committee voted unanimously to recommend approval of their new biologics application for Luxturna a gene therapy to deal with patients with vision loss because of a hereditary retinal disease, based on a business news release. Such favorable committee votes frequently bode well for Food and drug administration approval.

The Food and drug administration Cellular, Tissue and Gene Therapies Advisory Committee voted unanimously to recommend the therapy.

There is currently no known strategy to RPE65-mediated inherited retinal disease, which often results in complete blindness, based on principal Investigator Dr. Albert Maguire, who is another professor of ophthalmology at the Scheie Eye Institute at the College of Pennsylvania’s Perelman Med school. He is another physician in the Division of Pediatric Ophthalmology at Children’s Hospital of Philadelphia.

A Phase 3 trial of Luxturna was conducted from 2013 to 2015. The medical trial had 41 participants aged four to 44 years of age with vision loss spanning from mild to advanced. Confirmed biallelic RPE65 mutations and the existence of sufficient viable retinal cells were established in most participants, based on the release.

Still, the positive news was tempered with the matter that the potency of the therapy vary with respect to the quantity of viable retinal cells patients have remaining once they get the treatment, Endpoints noted citing Food and drug administration documents.

Other critical questions remain, namely the cost this gene therapy would command and just how Spark Therapeutics would charge for this.

The gene therapy developer is a spin from Children’s Hospital of Philadelphia.

The Food and drug administration set to start dating ? of The month of january 12 the coming year to examine whether or not to grant approval for Luxturna.

Other products in Spark’s pipeline include gene therapy programs to deal with neurodegenerative illnesses, hematologic disorders along with other types of inherited blindness.

Photo: Getty Images

¿Sus planes de Halloween incluyen ojos espantosos? Asegúrese de ver a su profesional en atención del ojo para obtener los adecuados para usted

Bay Area, 11 de octubre de 2017 /PRNewswire-HISPANIC PR WIRE/ — Los lentes de contacto decorativos pueden agregar la cantidad correcta de aterrador a su disfraz de Halloween. Pero usar lentes de contacto decorativos crime prescripción médica le puede causar infecciones del ojo graves o pérdida en visión permanente. Por eso es que la Academia Estadounidense en Oftalmología quiere recordarles a las personas que deben comprar únicamente lentes de contacto decorativos de minoristas que requieren una receta o venden productos aprobados por la Food and drug administration.

Foto – https://mma.prnewswire.com/media/581861/American_Academy_of_Ophthalmology_Halloween_Contact_Lens.digital

Cada año, los oftalmólogos tratan a pacientes que sufren de complicaciones dolorosas y cegadoras por usar lentes de contacto que no han sido preparados apropiadamente por united nations profesional en atención del ojo. Personas como:

  • Julian, 17, quedó ciego en united nations ojo después de usar lentes de contacto crime receta. Diez cirugías no pudieron reparar el daño que sufrió.
  • Laura, 20, tiene una cicatriz permanente y visión reducida después de usar sus lentes durante solamente 10 horas.
  • Robyn,14, requirió united nations trasplante de córnea después de usar lentes disfraz durante unas pocas horas.

Aunque es ilegal vender lentes de contacto crime receta, se pueden comprar en tiendas de productos de belleza, tiendas de disfraces y en la web. Anunciados falsamente como de “talle único” o “no se necesita una receta”, estos lentes pueden provocar daño grave a ojos.

Aunque usted tiene la visión perfecta, necesita obtener una receta válida y united nations examen de los ojos de united nations oftalmólogo – united nations médico que trata las condiciones y enfermedades del ojo – o optómetra. Los lentes de contacto boy united nations dispositivo médico.

Hay cuatro maneras por las cuales los lentes de contacto decorativos de venta libre pueden dañar seriamente los ojos:

  1. Los lentes de contacto de venta libre pueden rayar los ojos
    Los lentes de contacto que no quedan debidamente ajustados y del tamaño adecuado para la persona que los usa, pueden fácilmente rayar la córnea, la capa exterior del ojo. Las abrasiones en la córnea pueden causar enrojecimiento, sensibilidad a la luz, secreción, dolor o la sensación de tener algo incrustado dentro del ojo.
  2. Los contactos mal mantenidos pueden causar llagas
    Los lentes de contacto disfraz pueden crear una llaga ocular llamada úlcera corneal. Las úlceras a menudo se presentan como united nations punto blanco dentro del iris, la parte coloreada del ojo, y requieren tratamiento. Una vez que se cura la úlcera, muchos pacientes se quedan disadvantage una cicatriz significativa en la córnea que reduce la visión.
  3. Los contactos crime receta pueden producir infecciones dentro del ojo
    Tanto las abrasiones en la córnea como las úlceras crean aperturas a ojos, haciéndolos más vulnerables a bacteria y virus. Todos empresas pueden causar infecciones del ojo graves conocidas como queratitis.
  4. Los contactos crime receta pueden producir la ceguera
    A veces la formación de cicatrices de una infección es tan seria es necesario united nations trasplante en córnea para recuperar la visión. Los casos más extremos pueden terminar en ceguera.

Los lentes de contacto, incluyendo los lentes crime receta, no boy joyerías de fantasía. Boy dispositivos médicos regulados por la Food and drug administration que deben ser recetados y preparados apropiadamente por united nations profesional en cuidados de los ojos. Y deben ser tratados disadvantage las mismas normas higiénicas como los lentes de contacto regulares.

“No pierda su visión a lentes de contacto baratos”, alertó Thomas L. Steinemann, M.D., portavoz clínica para la Academia Estadounidense en Oftalmología. “Si requiere lentes de contacto para completar su disfraz de Halloween, evite los de venta libre a toda costa. Proteja su visión obteniendo lentes de receta de united nations profesional en atención del ojo”.

La Academia alienta a las personas a ver y compartir su Anuncio de servicio público “Ninguna receta, ninguna manera” (“No Presciption, Not A WayInch) que muestra el daño grave que estos lentes de contacto disfraz crime receta pueden causarle a los ojos.

Visite el sitio web EyeSmart® en Academia para obtener más información sobre la seguridad de lentes de contacto.

Acerca en Academia Estadounidense en Oftalmología (American Academy of Ophthalmology)
La Academia Estadounidense en Oftalmología (American Academy of Ophthalmology) es la asociación de médicos y cirujanos en vista más grande del mundo. Una comunidad global de 32,000 médicos, protegemos la vista y empoderamos vidas estableciendo las normas sobre la educación oftálmica y trabajando a big favor de nuestros pacientes y el público. Innovamos para fomentar la profesión y para asegurar la prestación de servicios de atención del ojo en más alta calidad. Nuestro programa EyeSmart® provee al público la información más fiable sobre la salud del ojo. Para más información, visite world wide web.aao.org.

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FUENTE American Academy of Ophthalmology

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Olympus Releases ORBEYE 4K-3D Surgical Microscope System



Olympus is releasing its latest surgical microscope, the 4K-3D ORBEYE video microscope. The unit was created with a partnership called The new sony Olympus Medical Solutions. The machine posseses an associated 4K-3D 55-inch monitor, allowing surgeons to appear directly in the screen as opposed to a microscope eyepiece and throughout the clinical staff to understand what’s happening. There is not the eyepiece option, because the only factor the adjustable arm keeps elevated may be the lens and digital sensors.

The microscope depends on two The new sony 4K ExmorRTM CMOS sensors as well as an image processor that maintains proper contrast and color precision. They operate in real-time, supplying a lag-free look at the significant space.

Not getting a bulky traditional microscopy setup clears in the area over the surgical field, which makes it simpler to obtain around and also to set some misconception. The whole product is itself smaller sized compared to previous comparable model from the organization, which makes it simple to wheel interior and exterior the OR as necessary.

Via: Olympus…

Editors

At Medgadget, we set of the most recent medical technology news, interview leaders within the field, and file dispatches from medical occasions from around the globe.

Dr. Kaweh Mansouri to provide Kahook Dual Blade (KDB) Clinical Data at 2017 ESCRS Congress

RANCHO CUCAMONGA, Calif., March. 7, 2017 /PRNewswire/ — New World Medical today announced that data will be provided evaluating the intraocular pressure (IOP) lowering effectiveness of cataract extraction (CE) coupled with either goniotomy performed using the Kahook Dual Blade (KDB, ” New World ” Medical) or trabecular meshwork microbypass device implantation (iStent®, Glaukos Corporation, San Clemente, CA).  These data will be provided by Dr. Kaweh Mansouri, MD, Miles per hour, from the Glaucoma Center, Montchoisi Clinic, Lausanne, Europe and also the Department of Ophthalmology, College of Colorado, Denver, throughout the annual meeting from the European Society of Cataract and Refractive Surgeons (ESCRS), being held October 7-11, 2017 in Lisbon, Portugal. 

The poster, titled Comparison from the Intraocular Pressure Lowering Effectiveness From a Novel Goniotomy Blade along with a Trabecular Meshwork Device, includes data from the retrospective chart overview of patients with mild-to-moderate glaucoma who went through CE with either KDB goniotomy or iStent implantation. The research required place at 12 sites (11 US, 1 Mexico) and evaluated publish-operative IOP in addition to medication utilization of 435 eyes treated either by CE+KDB or CE+iStent (198 and 237 eyes, correspondingly). 

At 6 several weeks, the mean IOP within the CE+KDB cohort shown a statistically significant greater reduction when compared with CE+iStent (24% versus 16%, correspondingly, p<0.05). This result was statistically significant as early as day 1, with a reduction of 14% in the KDB group versus 4% in the iStent group, and continued through the 6-month study period. The mean reduction in medication use between the two groups was significantly different with a 63% reduction in the CE+KDB group (1.7 to 0.6 medications) compared to 46% in the CE+iStent group (1.9 to 1.0 medications), p<0.05. Both groups had similar baseline demographics and reported comparable adverse events, which were mild and self-limited. 

“This huge study shows that goniotomy using the Kahook Dual Blade is able to provide significant reductions in IOP and medicine use in comparison with iStent for glaucoma patients undergoing cataract extraction,” stated Dr. Mansouri.  “These results represent an essential advance within the surgical procedure for patients undergoing cataract surgery who’ve out of control mild-to-moderate glaucoma or who wish to reduce their medication burden.”

About Glaucoma

Glaucoma is several complex eye illnesses which produce elevated pressure inside the eye.  This elevated pressure is because a backup of fluid and can harm the optic nerve, leading to vision loss and blindness.  Normal fluid flow and drainage occurs via a small, spongy tissue within the eye known as the trabecular meshwork (TM).  Once the TM becomes clogged, fluid cannot leave the attention as quickly as it’s created, and intraocular pressure (IOP) becomes elevated.

The mainstay of current treatment methods are the cut in IOP pharmacologically, by laser, or through incisional surgery.  Even though many topical medications are for sale to treat glaucoma, they might require consistent, regular use which could become unmanageable through the glaucoma patient population.  Recent evidence signifies that patients may considerably take advantage of the elimination of diseased TM tissue using a safe method that leads to sustained IOP reduction and reduced reliance on IOP-lowering medication. 

Concerning the Kahook Dual Blade

The Kahook Dual Blade (KDB) is definitely an elegant, single-use, ophthalmic blade made to make parallel incisions within the trabecular meshwork (TM) to boost aqueous output.  The KDB is precision engineered to slot in the Canal of Schlemm and also the unique ramp around the distal finish lifts and stretches the TM to ensure that the twin blades to excise the preferred part of diseased TM.

About ” New World ” Medical

” New World ” Medical began by Dr. A. Mateen Ahmed, who had been going to develop, manufacture, and market cutting-edge medical devices to ease ophthalmic ailments globally.  ” New World ” Medical’s mission would be to preserve and enhance vision by delivering innovations to any or all of humanity, and achieves this through partnerships with surgeons and eye care experts who focus on alleviating the responsibility of blindness around the world. The business’s flagship devices range from the Kahook Dual Blade and also the type of Ahmed Glaucoma Valves.  To understand more about the initial mission of ” New World ” Medical or their innovative products visit http://world wide web.newworldmedical.com.

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Enchroma Colorblind Glasses Review: Illuminating, But They Are They Well Worth The Money?

Color happens to be a mysterious in my experience. Growing up, I usually determined that making something red was simply adding “red color” to or onto it. College was after i really began to know that colors in biology were created of chemical pigments, each having a unique chemical structure. All of them absorbed another area of the visible light spectrum, and just what they didn’t absorb is exactly what we’re able to see. So a red ball could be absorbing blues and vegetables (and all sorts of colors of ROYGBIV except R), and reflecting reds.

When Enchroma arrived at to us to showcase their color-blindness glasses, I leaped in the chance. A couple of my research labmates are color blind, plus they volunteered to assist. Abdullah Syed is really a PhD student and Julien Couture-Senécal is definitely an undergraduate summer time student. Make certain within the Chan Lab in the College of Toronto, so we use light and it is spectrum every single day to determine the types of materials we make.

Syed and Julien attempted the happy couple meant for inside first, inside a chemistry laboratory atmosphere where brightly coloured fluids and plastics were aplenty. (It’s of observe that Abdullah attempted the Enchroma glasses on the top of his regular prescription glasses. Enchroma told us the glasses fail to work worn outrageous of prescription glasses as peripheral light enters the attention, skewing the number of light, but we attempted it by doing this anyhow. Enchroma does make glasses that suit over prescription eyewear. Julien used contacts, that are okay.)

First, a couple of apparent variations were noted, namely that select oranges grew to become a lot more red and vibrant. Interestingly, the Enchroma glasses also introduced out a subtle shade of blue-eco-friendly inside a chromatography column which was invisible without one. So, the glasses work and therefore are sometimes helpful.

But images on the computer monitor, for example fluorescence microscopy images full of reds and vegetables and blues, didn’t look different. Nor did the colour blind test using the colored dots and figures (Ishihara test) appear any simpler whenever we made it happen on the computer monitor. Most objects were exactly the same. (Note: We simply correctly tested one set of the provided glasses on the pc monitor, which switched to be intended for outdoors and never created for computer monitors. The indoor glasses, which are made to use computers, although not on Ishihara tests, we didn’t provide a proper vetting before a screen. We’d claim that Enchroma put obvious labels around the glasses indicating whether they’re for inside or outdoors.)

I was slightly dejected, however when we went outdoors, things began to occur. All of a sudden, both testers began realizing variations they hadn’t seen before. “Those flowers within the shadows – I normally wouldn’t have experienced them since the [red] petals and leaves match the [eco-friendly] leaves. I believe I could’ve basically looked for any lengthy time for you to consider it, however with the glasses, the red petals really pop as red.”

Abdullah Syed is really a microscopy and imaging expert. He ran the glasses via a Ultra violet-Visible spectrophotometer to determine how light had been modified because it goes through the glasses. Just like Enchroma describes online, these glasses stop an area between red and eco-friendly that removes the overlapped region and therefore, enables for a lot more discrimination during these colors. He hypothesized the reason these glasses didn’t work with computer monitors happens because monitors transmit colors as a mixture of pure red, eco-friendly, and blue (RGB) pixels. Pure colors have sharp spectra that wouldn’t be filtered by the Enchroma glasses, therefore it will make no difference. Evaluating the transmitting spectra from the Enchroma glasses using the spectra appearing out of a monitor, we have seen the glasses block precisely within the regions that monitors don’t produce. No question they didn’t make Ishihara test simpler. Exactly why the glasses labored better outdoors happens because nature produces colors in a lot more continuous spectra than mixing pure RGB dyes together.

Evaluating the transmittance spectra of Enchroma indoor and outside glasses using the spectra released with a typical LCD monitor that utilizes RGB pixels. The peaks from the LCD monitor match red, eco-friendly, and blue pixels. The valleys from the LCD monitor match parts of the Enchroma glasses which are filtered out, explaining why the glasses don’t change interpretation from the monitors.

Within the finish, wouldn’t it help? Both sides stated “maybe.” Mostly, the planet looks exactly the same for them. Subtle variations emerged once they looked longer and much more carefully. For instance, a gradient of red to pink in salvia flowers was surprisingly not recognized before the glasses were worn.

Julien stated it might be useful for experiencing the world more, especially on a holiday to a outdoors, simply because they make colors more vibrant and delightful. Abdullah said it will help, but he will have to relearn which colors were considering the glasses. For instance, he saw a yellow-brown wooden door like a questionable “green?” using the glasses, but because a duller grey without. For that cost, neither of the two would purchase them, but keep in your mind that both of them are students that will get looking forward to free pizza.

So these glasses act as described to boost colors in individuals with color-blindness, but our testers aren’t sure if they’re worthwhile. The cost is high however that might be because we’ve got the technology is totally new and sure takes considerable manufacturing to create. Considering that Abdullah and Julien have previously learned to adjust to the color-blinded way they see the world, these glasses aren’t worth their investment. Exactly what do we advise? If you possess the extra money, then get some and find out the planet more vibrantly for any awesome experience, but don’t expect so that it is all rainbows and butterflies.

Product page: Enchroma…

Phosphorus Launches Diagnostic Ophthalmology and Drug Response Genetic Tests

NEW You are able to, Sept. 13, 2017 /PRNewswire/ — Phosphorus, a computational genomics company, announced today adding two advanced genetic tests to the catalogue: An ophthalmologic test for inherited conditions connected with vision loss and blindness, along with a pharmacogenomic test to look at the effectiveness of numerous drugs for particular patients, based on their genes. The most typical retinal disorder around the ophthalmologic test, retinitis pigmentosa, claims an incidence rate of one in three.5 1000 individuals (Haim, 2002)1, along with other conditions tested exhibiting high incidence rates too. Similarly, genetics also take into account 20-95% of variability as a result of individual drugs (Kalow et al, 1998)2, with 10-20% of adverse drug reactions potentially associated with genetics (Ingelman-Sundberg, 2004)3.

Phosphorus’ new tests range from the very indepth panels of genes in line with the latest advances in research. They’ll be unveiled in the National Society of Genetic Counselors (NSGC) Annual Conference in Columbus, Ohio now.

“For inherited retinal disorders, dna testing may be used to prevent vision loss and blindness,” described Oscar Puig, Chief Scientific Officer at Phosphorus. “Furthermore, our new genetic tests for drug response will equip patients with information about how to higher optimize their medication.”

Phosphorus’ expert-curated panels, effective data analytics, and rigorous variant interpretations happen to be developed and designed to guarantee the most accurate recent results for patients. The exams are operated by next-generation sequencing technology, including comprehensive recognition of copy number variants. The straightforward testing workflow is made to ease the procedure for physicians and supply an inexpensive choice for patients as well as their family people.

“Using the launch in our ophthalmologic and pharmacogenomic tests, we’re expanding our portfolio of diagnostic products, including comprehensive tests in cardiology, oncology, and reproductive health. By pairing these studies with Phosphorus’ Elements software, we provide the very first finish-to-finish solution enabling laboratories and medical facilities to construct and expand their precision medicine abilities,” stated Alexander Bisignano, co-founder and Chief executive officer of Phosphorus.

The recently launched ophthalmology genetic test includes the next conditions:

  • Retinal Disorders: 146 genes. Includes genes connected with achromatopsia, Bardet-Biedl syndrome, cone-fishing rod dystrophy, Usher syndrome, hereditary stationary night blindness, Leber hereditary amaurosis, retinitis pigmentosa, and macular dystrophy.
  • Cataracts: 38 genes. Hereditary cataracts are the most typical reason for treatable childhood blindness, with 25-33% of cases being hereditary4.
  • Glaucoma: 18 genes. Early-onset glaucoma can result from hereditary conditions.
  • Corneal Dystrophy: 8 genes. About one in 1,000 people includes a corneal dystrophy that can result in vision loss after lasek5.

The recently launched drug response genetic test covers probably the most generally prescription drugs across a sizable mix portion of therapeutic areas, including cardiology, psychiatry, oncology, discomfort management, neurology, immunology, gastroenterology, respiratory system, infectious disease, yet others.

Find out more about Phosphorus tests in the National Society of Genetic Counselors Annual Conference in Columbus, Ohio at booth #350. See the company’s research poster presentation, “Obvious Indication for Cardiogenetics Testing Not Good GC Referral Options. How Can Genetic Counselors Think a Cardiologist Should Proceed?,” on Wednesday, September 13, 2017 from 5:15 PM to six:30 PM (poster A-10). See the company’s other research poster presentation, “CDC Tier 1 Genomic Applications: Awareness Among GCs and Potential Effect on GC Practices,” on Friday, September 15, 2017 from 1:15 to two:30 PM (poster C-9). Both presentations is going to be delivered within the exhibit hall.

About Phosphorus

Phosphorus is really a computational genomics company using the vision to produce a world where every healthcare decision is enhanced with genomics. Headquartered in New You are able to City, Phosphorus offers clinical genetic tests in a variety of clinical areas from the CLIA-certified laboratory. The organization also develops effective software that allows labs all over the world to provide probably the most advanced genetic tests. Phosphorus’ active development and research program comes with an initial concentrate on decoding the genetic reasons for infertility and inherited coronary disease. Having a group of experts in computational biology and information technology, Phosphorus is creating a data network that can help providers, researchers and patients all over the world better understand and harness the strength of a persons genome. To learn more visit: world wide web.phosphorus.com and @phosphorus.

1Haim M. Epidemiology of retinitis pigmentosa in Denmark. Acta Ophthalmol Scand Suppl. 2002(233):1-34.
2Kalow W, Tang BK, Endrenyi L. Hypothesis: comparisons of inter- and intra-individual variations can replacement for twin studies in drug research. Pharmacogenetics. 19988(4):283–289.
3Ingelman-Sundberg M. Pharmacogenetics of cytochrome P450 and it is applications in drug therapy: yesteryear, present and future. Trends Pharmacol Sci. 200425(4):193-200.
4Yi J. et al. (2011). Int J Ophthalmol, 4(4), 422-32.
5Lee J. et al. (2010). Ophthalmic Epidemiology, 17(3), 160-165.

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Smartphone Application to assist Identify Concussions Anywhere and Without Costly Equipment


You should identify concussions quickly. Way too frequently individuals which are affected continue doing the things they used to do, blissfully not aware to be impaired as well as in serious danger for other traumas and oncoming signs and symptoms from the brain trauma. Now a group at University of Washington has produced a smartphone application that tracks the movement from the pupils to recognize whether someone might or might not be concussed.

The PupilScreen application measures the eye’s pupillary light reflex, or the way the pupil changes its shape as a result of changes in the sunshine punching the eye. The individual being assessed simply compares the phone, the telephone creates a camera flash and records the person’s face, then deep learning algorithms process the taken video, calculating the rise in how big the pupil following a flash. Currently, a parcelled up can be used to put the smartphone into that blocks out surrounding light to be able to enhance the precision from the application, however the team believes you’ll be able to eventually to ease this necessity and also the investigators happen to be teaching the application to operate within an atmosphere with surrounding ambient lighting.

The formula that precisely differentiates between your pupil and surrounding regions of the attention depends on deep learning and lots of formerly expanded hard physical work. Particularly, they experienced about 4,000 eye images, annotating them so the application can learn to understand the pupil is and the way to outline it.

A preliminary overview of the application shown it having the ability to place significant traumatic brain injuries, however a bigger study involving EMTs, coaches, and doctors will assist you to measure the real abilities of PupilScreen.

Here’s a College of Washington video concerning the new application:

Connect to the white-colored paper: PupilScreen: Using Smartphones to evaluate Traumatic Brain Injury…

Via: College of Washington…

Editors

At Medgadget, we set of the most recent medical technology news, interview leaders within the field, and file dispatches from medical occasions from around the globe.