Intraocular Pressure News
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Bayer submits aflibercept 8 mg for marketing authorization in Japan
Submission to the Ministry of Health, Labor, and Welfare (MHLW) in Japan for aflibercept 8 mg in neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME) is based on positive results of phase III clinical trials, PULSAR and PHOTON In both trials, aflibercept 8 mg demonstrated unprecedented durability results with treatment intervals of up to 16 weeks, with ...
By Bayer AG
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Bayer submits aflibercept 8 mg for regulatory approval in two major retinal eye diseases in the EU
Filing for aflibercept 8 mg in neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME) is based on positive results of clinical trials, PULSAR and PHOTON In both trials, aflibercept 8 mg demonstrated unprecedented durability results with treatment intervals of up to 16 weeks, with comparable visual acuity as well as rapid and resilient fluid control to the ...
By Bayer AG
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Detailed data from pivotal studies with aflibercept 8 mg demonstrate sustained improvements in visual acuity and anatomic measures with large majority of patients maintaining treatment intervals of 16 weeks at week 48
Aflibercept 8 mg demonstrated non-inferior vision gains to Eylea® (aflibercept 2 mg) with 83% of patients with neovascular (wet) age-related macular degeneration (nAMD) and 93% of patients with diabetic macular edema (DME) maintaining dosing intervals of 12 weeks or longer through week 48 Superior fluid control in nAMD and robust disease control through to week 48 in nAMD and DME In both ...
By Bayer AG
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Positive Data Presentations at AAO Annual Meeting Demonstrate Utility and Versatility of Clearside Biomedical’s Proprietary Suprachoroidal Space Platform
Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical company revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space (SCS®), announced today that clinical data from multiple internal and partnered programs were presented at the recent 2022 Annual Meeting of the American Academy of Ophthalmology (AAO), the world's largest association of eye ...
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iSTAR Medical appoints leading glaucoma specialist Prof. Kaweh Mansouri as Chief Medical Officer
WAVRE, Belgium — 6 September 2022: iSTAR Medical, a medtech company delivering breakthrough eye care solutions to patients, today announces the appointment of Dr Kaweh Mansouri as Chief Medical Officer (CMO). Dr Mansouri is a medical and surgical eye specialist, sub-specializing in glaucoma and cataract. Currently a Consultant Ophthalmologist at the Glaucoma Center, Swiss Visio, ...
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AbbVie and iSTAR Medical Announce Strategic Alliance for the Treatment of Glaucoma
NORTH CHICAGO, Ill. and WAVRE, BELGIUM, July 20, 2022 – AbbVie (NYSE: ABBV) and iSTAR Medical SA, today announced a strategic transaction to further develop and commercialize iSTAR Medical’s MINIject® device, a next-generation minimally invasive glaucoma surgical (MIGS) device for patients with glaucoma. This complementary alliance will support iSTAR Medical’s development ...
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Prof. Dr med. Marc Schargus presents a pooled meta-analysis on MINIject at DOC 2022
A meta-analysis from the STAR-I, STAR-II and STAR-III trials on MINIject® was presented at the 34th International Congress of German Ophthalmic Surgeons (DOC) by Prof. Dr med. Marc Schargus (Asklepios Klinik Nord, Hamburg). It was entitled, “Patients with Open Angle Glaucoma Who Consistently Achieve Low Intraocular Pressures (≤18 mmHg) up to Two-years after Implantation with ...
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iSTAR Medical to attend the 34th International Congress of German Ophthalmic Surgeons (DOC)
We will be in Nuremberg next week at the DOC congress where Prof. Dr med. Marc Schargus (Asklepios Klinik Nord, Hamburg) will be presenting a meta-analysis from the STAR-I, STAR-II and STAR-III trials on patients with open-angle glaucoma who consistently achieve low diurnal intraocular pressures (IOP) of ≤18 mmHg up to two-years after implantation with MINIject. The Advanced Glaucoma ...
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iSTAR Medical Presents Positive Consistent Results for MINIject Across Three International Glaucoma Trials
Analysis provides further validation of MINIject®’s meaningful and sustained efficacy in open angle glaucoma patients No safety concerns with corneal endothelial health reported across all three trials MINIject® delivers positive, consistent results up to two-year follow-up in patients across Central and South America, Asia and Europe WAVRE, Belgium — 8 June 2022: ...
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Sight Sciences’ OMNI® Surgical System Reduces IOP, Daily Fluctuations in IOP and Medication Use, as Shown in Newly Published 12-Month Clinical Datagrafic lines 4 Sight Sciences’ OMNI® Surgical System Redu
Sight Sciences, Inc. (Nasdaq: SGHT), an eyecare technology company focused on developing and commercializing innovative solutions intended to transform care and improve patients’ lives, today announced publication in Clinical Ophthalmology of its 12-month outcomes in the GEMINI study, including results from a Hispanic population subset. The final study results demonstrated that canaloplasty ...
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iSTAR Medical Expands Commercial Rollout with First MINIject Surgeries in Switzerland
The only commercially available MIGS device currently targeting the supraciliary space now available to patients and surgeons in Switzerland First implantations performed by Prof. Dr Kaweh Mansouri at Swiss Visio, Clinique de Montchoisi, Lausanne and Prof. Dr med. Jan Darius Unterlauft at Inselspital, Bern WAVRE, Belgium — 10 May 2022: iSTAR Medical, a medtech company delivering ...
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RG6501 (OpRegen) Phase 1/2a Clinical Results Support the Potential for OpRegen to Slow, Stop or Reverse Disease Progression in Geographic Atrophy Secondary to Age-Related Macular Degeneration
12-Month Primary Endpoint Data Suggest OpRegen is Well Tolerated with an Acceptable Safety Profile Preliminary Evidence of Visual Function and Outer Retinal Structure Improvements Observed in Cohort 4 Patients with GA and Impaired Vision Data Reported at 2022 ARVO Meeting by Allen C. Ho, M.D., FACS Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage ...
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Sight Sciences Reports Fourth Quarter and Full Year 2021 Financial Resultsgrafic lines 4 Sight Sciences
Sight Sciences, Inc. (Nasdaq: SGHT), an eyecare technology company focused on creating innovative solutions intended to transform standards of care and improve patients’ lives, today reported financial results for the quarter and year ended December 31, 2021. Recent Business Highlights Generated 2021 total revenue of $49.0 million, an increase of 77% compared to the prior year ...
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Sight Sciences Launches “Don’t Wait for Too Late” Awareness Campaign for Glaucoma
Sight Sciences, Inc. (Nasdaq: SGHT), an eyecare technology company focused on creating innovative solutions intended to transform standards of care and improve patients’ lives, today announced the launch of its “Don’t Wait for Too Late” educational campaign designed to raise awareness among the optometric community of minimally invasive glaucoma surgery (MIGS) as an ...
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iSTAR Medical shows initial positive progress of US STAR-V trial for MINIject
Pivotal trial of MINIject, STAR-V, now initiated in 13 sites across the US Positive feedback from world-leading glaucoma surgeons involved in the trial MINIject is the only commercially available MIGS device targeting the supraciliary space. Commercial rollout continues following European approval in 2021 WAVRE, Belgium — 12 January 2022: iSTAR Medical, a medtech company delivering ...
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Glaukos’ iDose TR Demonstrates Sustained IOP Reduction and Favorable Safety Profile Over 36 Months in Phase 2b Study
Approximately 70% of Subjects were Well-Controlled on iDose TR with the Same or Fewer Topical IOP-Lowering Medications at 36 Months vs. Screening Favorable Safety Profile Through 36 Months . SAN CLEMENTE, Calif.--(BUSINESS WIRE)-- Glaukos Corporation (NYSE: GKOS), an ophthalmic medical technology and pharmaceutical company focused on novel therapies for the treatment of glaucoma, corneal ...
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Ivantis Announces First Patient Enrolled in Pivotal Clinical Trial Evaluating the Hydrus Microstent in Standalone MIGS for Mild to Moderate Glaucoma
Ivantis Inc., developer of the novel Hydrus® Microstent, a minimally invasive glaucoma surgery (MIGS) device intended to lower eye pressure for open-angle glaucoma patients, today announced that the first patient has been enrolled in a pivotal clinical trial evaluating the Hydrus Microstent in patients with mild to moderate open-angle glaucoma, without concurrent cataract surgery. Up to 80% ...
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Microinvasive Glaucoma Surgery with the OMNI Surgical System is Associated with Diminished Diurnal IOP Fluctuations, a Significant, Independent Risk Factor for Glaucoma Progression
Sight Sciences, Inc. (Nasdaq: SGHT), an eyecare technology company focused on creating innovative solutions intended to transform standards of care and improve patients’ lives, today announced publication in Clinical Ophthalmology of favorable data showing that microinvasive glaucoma surgery (MIGS) using the OMNI® Surgical System suppressed daily fluctuations in intraocular pressure ...
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Hydrus Microstent Lowers Visual Field Loss by 47% According to New 5-Year Pivotal Trial Data
Ivantis Inc., developer of the novel Hydrus® Microstent, a minimally invasive glaucoma surgery (MIGS) device intended to lower eye pressure for open-angle glaucoma patients, has announced new data from its five-year HORIZON pivotal trial showing that the Hydrus Microstent lowers the rate of visual field loss by 47% versus cataract surgery alone. The breakthrough findings position the ...
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Ivantis Announces Settlement of Glaukos Patent Litigation
Ivantis, Inc., developer of the novel Hydrus® Microstent, a minimally invasive glaucoma surgery (MIGS) device designed to lower eye pressure for open-angle glaucoma patients, today announced that it has entered into an agreement with Glaukos Corporation to settle and dismiss all pending global litigation between them. Under the agreement’s terms, Ivantis has agreed to pay a total of ...
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