Glaukos wins FDA nod for IDE trial of iStent SA

Glaukos (NYSE:GKOS) said today it won FDA investigational device exemption to launch a pivotal study of its iStent SA trabecular micro-bypass system designed to treat glaucoma. The San Clemente, Calif.-based company’s iStent SA is designed to reduce intraocular pressure in psuedophakic, mild-to-moderate open-angle, pigmentary or psuedoexfoliative glaucoma patients, the company said. The system includes 2 micro-scale titanium stents in an auto-injection system which can be injected into trabecular meshwork locations through a single corneal entry point to restore physiological outflow of aqueous humor into the Sclemm’s canal. “We are delighted that our successful collaboration with the FDA allows Glaukos to begin the pivotal phase of this first-ever standalone Micro-Invasive Glaucoma Surgery, or MIGS, trial. We pioneered MIGS to overcome the challenges of conventional glaucoma therapies. Our commencement of the iStent SA trial brings us a step closer to making an approved MIGS option available to address an unmet clinical need and to treat a wider cohort of glaucoma patients,” prez &CEO Thomas Burns said in a press release. Glaukos’ multi-center, pivotal randomized trail aims to enroll 400 patients to evaluate the iStent SA compared to selective laser trabeculoplasty procedures. A total of 80 patients from the initial trial phase will be included in the pivotal trial, the company said. The primary efficacy endpoint of the trial ...
Source: Mass Device - Category: Medical Devices Authors: Tags: Clinical Trials Food & Drug Administration (FDA) Optical/Ophthalmic Regulatory/Compliance Glaukos Source Type: news

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Effects of chemical injuries on the cornea and limbus have been widely studied; however, little is known about glaucoma after ocular chemical injuries. We herein investigated the incidence, risk factors, and outcome of glaucoma in patients with ocular chem...
Source: SafetyLit - Category: International Medicine & Public Health Tags: Burns, Electricity, Explosions, Fire, Scalds Source Type: news
Conclusions: The Lux keratoprosthesis was developed for patients with severe cicatricial keratoconjunctivitis who were otherwise not candidates for existing keratoprosthesis designs. Short-term outcomes after implantation of the Lux keratoprosthesis were encouraging.
Source: Cornea - Category: Opthalmology Tags: Clinical Science Source Type: research
Abstract BACKGROUND/AIMS: To evaluate long-term visual outcomes of Boston type I keratoprosthesis (KPro) surgery and identify risk factors for visual failure. METHODS: Single surgeon retrospective cohort study including 85 eyes of 74 patients who underwent KPro implantation to treat severe ocular surface disease, including limbal stem cell deficiency, postinfectious keratitis, aniridia and chemical burns. Procedures were performed at the Centre hospitalier de l'Université de Montréal from October 2008 to May 2012. All patients with at least 5 years of follow-up were included in the analysis, inc...
Source: The British Journal of Ophthalmology - Category: Opthalmology Authors: Tags: Br J Ophthalmol Source Type: research
Authors: Rüfer F Abstract Glaucoma therapy usually includes lowering IOP, but a healthy lifestyle may also be recommended. We discuss how this can be defined and the underlying secondary neuroprotective mechanisms. One neuroprotective measure is to avoid common neurotoxic pollution like cigarette smoking, ethanol, methanol or lead. Nutrition should be rich in variety and prevent vitamin B12 and folate deficiency. Supernutrition may lead to the metabolic syndrome and increase IOP, arterial hypertension and serum steroid levels. The metabolic syndrome can also lead to decreased renal function, which can cause ac...
Source: Klinische Monatsblatter fur Augenheilkunde - Category: Opthalmology Tags: Klin Monbl Augenheilkd Source Type: research
Conclusions: A rapidly initiated, inflammatory (TNF-α mediated), IOP-independent pathway to glaucoma, resulting from acute anterior segment trauma or surgery, has been identified in laboratory studies. Prompt prophylactic treatment with antiinflammatory agents has been shown to be markedly neuroprotective of retinal ganglion cells, presumably capable of reducing the risk of late glaucoma.
Source: Cornea - Category: Opthalmology Tags: Special Article Source Type: research
You're reading 8 Nootropics to Stimulate Your Brain This Fall, originally posted on Pick the Brain | Motivation and Self Improvement. If you're enjoying this, please visit our site for more inspirational articles. Nootropics is a term coined by Dr. Corneliu E. Giurgea to describe a class of drugs, supplements, and other synthetic and naturally occurring compounds that improve cognitive function in our brains. They’re often called “smart drugs,” as they can help us think faster and more efficiently. Although used by pretty much everyone, these nootropic supplements are especially popular among youn...
Source: PickTheBrain | Motivation and Self Improvement - Category: Consumer Health News Authors: Tags: featured health and fitness self improvement nootropics pickthebrain Source Type: blogs
Glaukos has been open about a plan to go beyond being a “just” a medical device company. During a presentation to investors at the 37th annual J.P. Morgan Healthcare Conference, San Clemente, CA-based Glaukos’ CEO Thomas Burns said the company was transforming into a “hybrid surgical/pharmaceutical/medical device” firm. Glaukos is the frontrunner in Micro-invasive glaucoma surgery (MIGS) and was the first to have an approved device in the space. MD+DI named Glaukos’ plan to become a hybrid company as one ...
Source: MDDI - Category: Medical Devices Authors: Tags: Implants Business Source Type: news
ABSTRACT Glaucoma is the leading cause of irreversible blindness worldwide and can affect a broad array of daily activities, including driving. Recently, studies investigating the relationship between driving performance and glaucoma have received a great deal of interest. Assessment of driving behavior is not straightforward because driving is a complex skill involving significant multi-tasking ability. In this review, we summarize recent work from clinical studies investigating how glaucoma can affect driving performance. Patients with glaucoma are more likely to be involved in motor vehicle collisions when compared to h...
Source: Arquivos Brasileiros de Oftalmologia - Category: Opthalmology Source Type: research
This study shows that not only are Glaukos’ iStents as effective as once-daily topical travoprost in controlling IOP, but they also succeed at maintaining IOP reductions over the long-term with fewer additional medications.” Three-year outcomes of this study were published in 2016 in Ophthalmology and Therapy. The most recent article detailing five-year outcomes may be accessed online here. “This latest publication represents the first-ever five-year, protocol-driven, randomized evaluation of standalone iStent implantation in newly diagnosed glaucoma patients,” said Glaukos prez &CEO Thomas Burn...
Source: Mass Device - Category: Medical Devices Authors: Tags: Blog Clinical Trials Featured Implants News Well Optical/Ophthalmic Vision Glaukos Ivantis Source Type: news
Light-Induced Pupillary Responses in Alzheimer's Disease Pratik S. Chougule1, Raymond P. Najjar1,2, Maxwell T. Finkelstein1, Nagaendran Kandiah3,4 and Dan Milea1,2,5* 1Department of Visual Neurosciences, Singapore Eye Research Institute, Singapore, Singapore 2The Ophthalmology &Visual Sciences ACP, Duke-National University of Singapore (NUS) Medical School, Singapore, Singapore 3Department of Neurology, National Neuroscience Institute, Singapore, Singapore 4Duke-National University of Singapore (NUS), Singapore, Singapore 5Singapore National Eye Centre, Singapore, Singapore The impact of Alzheimer&...
Source: Frontiers in Neurology - Category: Neurology Source Type: research
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