Intraocular 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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Bayer receives positive CHMP opinion for Eylea in the EU for treatment of preterm infants with retinopathy of prematurity
Recommendation is based on the Phase III study FIREFLEYE and data from the follow-up study FIREFLEYE NEXT Retinopathy of prematurity (ROP) can lead to severe visual impairment and blindness Bayer will apply for a patent term extension for the patent covering aflibercept, the active ingredient in Eylea™, of six months once the European Commission adopts a decision for a label extension ...
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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Atia Vision, a Shifamed Portfolio Company, to Close on $42m Series E Financing
CAMPBELL, CA – August 2, 2022 – Atia Vision, Inc., a Shifamed portfolio company committed to improving patient outcomes through the development of a modular presbyopia-correcting intraocular lens (IOL), announced today the first close of a $42M Series E financing. Led by Cormorant Asset Management, with participation by The Capital Partnership (TCP), PA MedTech VC Fund, AMED Ventures ...
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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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Two New Innovative Swiss Made EDOF IOLs for Cataract Surgery
The company Swiss Advanced Vision (SAV-IOL SA) announced today the launch of LUCIDIS and EDEN, two new intraocular lenses (IOLs) for the cataract surgery, both using the Instant Focus EDOF patented technology. With a brand-new concept, LUCIDIS brings two major achievements for the monofocal market: extending the depth of focus on a monofocal lens while being the first affordable EDOF IOL. Thanks ...
By SAV-IOL SA
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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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Eyevensys Recaps Highlights from Investigator Meeting and Presentations at the ARVO 2022 Annual Conference
Eyevensys, a privately held, clinical-stage biotechnology company developing non-viral gene therapies for ophthalmic diseases, today provided highlights from the Association for Research in Vision and Ophthalmology (ARVO) 2022 Annual Conference held in Denver, Colorado. In addition to its participation in the event, Eyevensys also held a successful meeting with principal investigators involved in ...
By Eyevensys
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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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Eyevensys to present at The Association for Research in Vision and Ophthalmology (ARVO) 2022 Annual Meeting
Eyevensys, a privately held, clinical-stage biotechnology company developing non-viral gene therapies for ophthalmic diseases today announced that the company will be presenting preclinical data on its two lead candidates for geographic atrophy (GA) and wet AMD at the upcoming Association for Research in Vision and Ophthalmology (ARVO) 2022 Annual Meeting. The conference will be held May 1-4, ...
By Eyevensys
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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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UNITY Biotechnology Announces Additional Data from Phase 1 Study of UBX1325 in Advanced Vascular Eye Disease
24-week UBX1325 Phase 1 data presented at Angiogenesis, Exudation, and Degeneration 2022 Conference Patients with diabetic macular edema (DME) and wet age-related macular degeneration (wAMD) showed improvement in visual acuity through 24 weeks following single dose of UBX1325 Phase 2 clinical studies of UBX1325 currently enrolling patients with DME and wAMD UNITY Biotechnology, Inc. ...
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