Glaukos submits IND for Travoprost eluting iDose

Glaukos (NYSE:GKOS) said it submitted an Investigational New Drug application to the FDA for its Travoprost intraocular implant delivered with the company’s iDose delivery system to reduce elevated intraocular pressure in patients with glaucoma. The Travoprost intraocular implant is injected through a clear corneal incision and secured in the anterior chamber, where the iDose system provides continuously elutes therapeutic levels of medication for an extended period of time, Glaukos said. “This IND submission represents a seminal milestone, which the Glaukos team achieved well ahead of our original 2016 timeline. We believe this micro-scale implant may be a viable answer to the ubiquitous and long-standing problem of patient non-compliance with prescription eye drops and we look forward to working cooperatively with the FDA as they review our IND submission,” CEO Thomas Burns said in a press release. Travoprost is a prostaglandid analog that is used to reduce IOP, and Glaukos intends to conduct a randomized Phase II clinical trial to assess the safety and efficacy of 2 models of the iDose system with Travoprost, compared against topical treatment with timilol maleate ophthalmic solution. The IND application from the company included information on the drug’s history of safety and efficacy, as well as data from a 69-patient preclinical program of the drug which reported mean IOP lower in the treatment group than the topical medicatio...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Clinical Trials Food & Drug Administration (FDA) Optical/Ophthalmic Regulatory/Compliance Glaukos Corp. Source Type: news

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Glaukos is probably at the top of its game when it comes down to maintaining a presence in the micro-invasive glaucoma surgery (MIGS) market. The San Clemente, CA-based company reaffirmed its laser-like focus on the market during a presentation at the 37th annual J.P. Morgan Healthcare Conference earlier on Wednesday. Glaukos’ CEO Thomas Burns began his presentation speaking on the strengths of the firm and its goals going forward. “Our mission is aspirational,” Burns said. “As a company we are seeking to transform glaucoma therapy, and in doing so we ...
Source: MDDI - Category: Medical Devices Authors: Tags: Business Source Type: news
Glaukos (NYSE:GKOS) said today it won FDA premarket approval for its iStent inject trabecular micro-bypass system. With the clearance, the iStent inject is now indicated for use in the reduction of intraocular pressure in adults with mild to moderate primary open-angle glaucoma who are undergoing concomitant cataract surgery. San Clemente, Calif.-based Glaukos said the iStent inject is designed to treat mild-to-moderate open-angle glaucoma in patients undergoing cataract surgery. It uses a pair of heparin-coated titanium stents in a pre-loaded auto-injection system that allows them to be injected into multiple trabecu...
Source: Mass Device - Category: Medical Devices Authors: Tags: Food & Drug Administration (FDA) Optical/Ophthalmic Pre-Market Approval (PMA) Regulatory/Compliance Glaukos Source Type: news
Glaukos (NYSE:GKOS) today released two-year data from the FDA investigational device exemption pivotal trial of its iStent inject trabecular micro-bypass system, and announced a patent infringement suit it filed against Ivantis. Results of the 505-patient study were presented at the American Society of Cataracts and Refractive Surgery annual meeting by Dr. Thomas Samuelson of the Minnesota Eye Consultants, the San Clemente, Calif.-based company said. The iStent inject trabecular micro-bypass system is designed to treat mild-to-moderate open-angle glaucoma in patients undergoing cataract surgery. It uses a pa...
Source: Mass Device - Category: Medical Devices Authors: Tags: Clinical Trials Optical/Ophthalmic Patent Infringement Glaukos Source Type: news
Glaukos (NYSE:GKOS) today released results from a study of its iStent trabecular micro-bypass stent exploring its use during cataract surgery in patients with severe open-angle glaucoma, touting significant reductions in intraocular pressure and medication use. The San Clemente, Calif.-based company’s iStent micro-bypass stents are made from non-ferromagnetic titanium and coated in heparin, is designed to be implanted into multiple trabecular meshwork through a single corneal entry point to reduce IOP. Results were published in the January issue of the Journal of Glaucoma. “Although the iStent&nb...
Source: Mass Device - Category: Medical Devices Authors: Tags: Clinical Trials Optical/Ophthalmic Glaukos Source Type: news
Glaukos (NYSE:GKOS) said today that it filed for pre-market approval from the FDA of its iStent Inject trabecular micro-bypass stent for treating glaucoma. San Clemente, Calif.-based Glaukos said the device is designed to treat mild-to-moderate open-angle glaucoma in patients undergoing cataract surgery. It used a pair of heparin-coated titanium stents in a pre-loaded auto-injection system that allows them to be injected into multiple trabecular meshwork locations via a single corneal entry point. “This PMA submission marks a significant milestone for Glaukos as we continue to deliver our deep pipeline of n...
Source: Mass Device - Category: Medical Devices Authors: Tags: Food & Drug Administration (FDA) Optical/Ophthalmic Regulatory/Compliance Glaukos Source Type: news
Conclusions: LCT proved to be the best option for treating corneal thinning. AMT represents an alternative that allows good visual recovery but does not restore corneal thickness as efficiently as LCT.
Source: Cornea - Category: Opthalmology Tags: Clinical Science Source Type: research
Glaukos (NYSE:GKOS) said today it created a direct sales organization to commercially launch its iStent inject trabecular micro-bypass stent for alleviating intra-ocular pressure. The iStent Inject is made from non-ferromagnetic titanium and coated in heparin, designed to be implanted into multiple trabecular meshwork through a single corneal entry point to reduce IOP, the company said. “The advent of Micro-Invasive Glaucoma Surgery, or MIGS, is revolutionizing the way we treat glaucoma patients and the commercial launch of iStent inject in Canada underscores the continuing advance of this excitin...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Business/Financial News Optical/Ophthalmic Stents Glaukos Corp. Source Type: news
Abstract To report the clinical and microbiological characteristics of infectious endophthalmitis after Boston type I keratoprosthesis (B–K-Pro) implantation. Retrospective analysis of 136 eyes that received a B–K-Pro type 1 between 1999 and 2012 was performed. Five eyes with a diagnosis of exogenous endophthalmitis after B–K-pro type 1 were identified and information about demographic data, indication for K-Pro, post-operative bandage contact lens use, post-operative prophylactic antibiotic use, timing and clinical presentation of endophthalmitis, gram stain and culture results of intraocular f...
Source: International Ophthalmology - Category: Opthalmology Source Type: research
Glaukos (NYSE:GKOS) said today it won approval from Health Canada for its iStent Inject trabecular micro-bypass stent designed for use in cataract surgeries to treat glaucoma. The newly cleared iStent inject is indicated for micro-invasive glaucoma surgery procedures to reduce intraocular pressure in patients with primary open-angle glaucoma, pseudoexfoliative glaucoma or pigmentary glaucoma, the Laguna Hills, Calif-based company said. “The Health Canada approval of the iStent inject is another important advancement in the MIGS category. MIGS devices, used early in the glaucoma treatment algorithm, can...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Implants Optical/Ophthalmic Regulatory/Compliance Stents Glaukos Corp. Health Canada Source Type: news
Abstract To report the clinical and microbiological characteristics of infectious endophthalmitis after Boston type I keratoprosthesis (B–K-Pro) implantation. Retrospective analysis of 45 eyes that received a B–K-Pro type 1 between 2009 and 2012 was performed. Five eyes with a diagnosis of exogenous endophthalmitis after B–K-pro type 1 were identified and information about demographic data, indication for K-Pro, post-operative bandage contact lens use, post-operative prophylactic antibiotic use, timing and clinical presentation of endophthalmitis, gram stain and culture results of intraocular flu...
Source: International Ophthalmology - Category: Opthalmology Source Type: research
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