Diabetes Retinopathy Articles & Analysis
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Digital Diagnostics, Kingdom of Saudi Arabia Sign Intent to Provide Preventative Diabetic Healthcare to 35M
CORALVILLE, IOWA July 21, 2022 – Leadership from Digital Diagnostics – maker of IDx-DR, the first-ever FDA-cleared, fully autonomous AI system for the diagnosis of diabetic retinopathy – signed a memorandum of understanding (MOU) with the Kingdom of Saudi Arabia’s Ministry of Investment during a ceremonial visit with United States of America President Joe Biden. With this ...
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Digital Diagnostics and Orbis International announce study to help save sight in Bangladesh
(Coralville, IA.) May 19, 2021 – Digital Diagnostics, developers of IDx-DR, an FDA De Novo-cleared autonomous AI system for the detection of diabetic retinopathy (DR) and diabetic macular edema (DME), and Orbis International, the influential nonprofit dedicated to fighting avoidable blindness around the world, have partnered on a study that will bring high-quality disease detection to ...
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Digital Diagnostics Extends Appreciation to CMS for Improving Access to Innovative, Validated Healthcare AI Designed to Eliminate Disparities and Drive Equity
Coralville, Iowa, November 2, 2021 – Digital Diagnostics commends the Centers for Medicare & Medicaid Services (CMS) for recognizing that FDA-cleared, rigorously validated healthcare autonomous artificial intelligence (AI) can address health care disparities and drive health equity. CMS’ CY 2022 Medicare Physician Fee Schedule (MPFS) and CY 2022 Outpatient Prospective Payment ...
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Digital Diagnostics Partners with Rapidly Scaling Medicare Advantage Organization, ArchWell Health
CORALVILLE, IOWA July 26, 2022 – Digital Diagnostics is proud to announce a partnership with ArchWell Health to bring IDx-DR, the autonomous AI diagnostic system for the detection of diabetic retinopathy (DR) – including diabetic macular edema (DME) – to ArchWell Health centers across the United States. “ArchWell Health is committed to improving patient outcomes and ...
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Valo Announces First Patient Dosed in the OPL-0401 Phase 2 study of an oral ROCK1/2 inhibitor for the Treatment of Non-Proliferative Diabetic Retinopathy
Valo Health, Inc. (“Valo”), the technology company focused on transforming the drug discovery and development process using human-centric data and artificial intelligence, today announced that dosing has commenced in its Phase 2 study — a multi-center ...
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UNITY Biotechnology to Present Clinical Data at the Association for Research in Vision & Ophthalmology (ARVO) 2022 Annual Meeting
UNITY Biotechnology, Inc. (“UNITY”) [NASDAQ: UBX], a biotechnology company developing therapeutics to slow, halt, or reverse diseases of aging, today announced that clinical data results from the Phase 1 study of its lead senolytic candidate, UBX1325, in patients with diabetic macular edema and wet age-related macular degeneration will be presented at the Association for Research in ...
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Ocular diseases and the rise of Biologics in the field of Ophthalmology
Speaking at the American Academy of Optometry 2021 annual meeting in Boston, Anthony DeWilde, OD, FAAO, discussed biologics, which hold promise for the treatment of ophthalmic diseases. Original Post can be read here. A wide range of articles cover the use of biologics in oncology. Apart from oncology, biologics have been successful in various therapeutic indications as listed in Annexure A. ...
By Qprotyn Inc
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Alkahest Announces Initiation of Phase 2b Clinical Trial of AKST4290 in Patients with Treatment-Naïve Wet Age-Related Macular Degeneration
Alkahest, Inc., a clinical stage biotechnology company focused on discovering and developing transformative therapies to treat age-related diseases, today announced the initiation of a phase 2b clinical trial of its orally administered small molecule CCR3 inhibitor, AKST4290. The company has dosed the first subject in AKST4290-205 (PHTHALO), which will assess the effects of AKST4290 on visual ...
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UNITY Biotechnology Completes Enrollment in BEHOLD, the Phase 2 Study of Senolytic Candidate UBX1325 in Diabetic Macular Edema
12-week safety and efficacy data anticipated by mid-year 2022 24-week safety and efficacy data anticipated before year-end 2022 UNITY Biotechnology, Inc. (“UNITY”) [NASDAQ: UBX], a biotechnology company developing therapeutics to slow, halt, or reverse diseases of aging, has completed enrollment for the BEHOLD study, its Phase 2 clinical trial of UBX1325 in patients with ...
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UNITY Biotechnology Doses First Patient in ENVISION, the Phase 2 Study of UBX1325 in Wet Age-Related Macular Degeneration
UNITY Biotechnology, Inc. (“UNITY”) [NASDAQ: UBX], a biotechnology company developing therapeutics to slow, halt, or reverse diseases of aging, today announced that the first patient has been dosed in the ENVISION study, its Phase 2 clinical trial of UBX1325 in patients with wet age-related macular degeneration (wAMD). “The clinical and preclinical data generated so far ...
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Digital Diagnostics Named to the 2022 CB Insights’ Digital Health 150 List
Coralville, Iowa December 7, 2022 — Digital Diagnostics – a leading AI diagnostics company on a mission to transform global healthcare – is a recipient of CB Insights’ fourth-annual Digital Health 150. The list recognizes the 150 most promising private digital health companies of 2022. “From reimagining clinical care, to leveraging tech like AR/VR to improve ...
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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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Clearside Biomedical Enters into Non-Dilutive Financing Agreement with HealthCare Royalty Partners for up to $65 Million
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 it has entered into a Royalty Interest Purchase and Sale Agreement (the agreement) with HealthCare Royalty Partners (HealthCare Royalty). Clearside intends to use the proceeds from the agreement to ...
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Aflibercept 8 mg in diabetic macular edema first to achieve sustained vision gains with up to 83% of patients extended to 16-24 weeks at two years
Data from pivotal PHOTON trial demonstrate long term efficacy of aflibercept 8 mg with extended intervals comparable to Eylea (aflibercept 2 mg) at fixed 8-weekly dosing over two years Patients assigned to a 16-week dosing regimen at baseline received a mean of 7.8 injections (6 fewer than Eylea) Safety profile of aflibercept 8 mg in diabetic macular edema (DME) remains comparable to Eylea ...
By Bayer AG
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Ocugen, Inc. Announces U.S. FDA Acceptance of Investigational New Drug Application to Initiate a Phase 1/2 Clinical Trial for Gene Therapy Candidate OCU400 to Treat Inherited Retinal Degeneration
Gene therapy candidate has potential to address a large number of retinitis pigmentosa and Leber congenital amaurosis gene mutations with a single product Trial to start in Q1 2022 will enroll patients with mutations in NR2E3 or RHO genes MALVERN, Pa., Dec. 09, 2021 (GLOBE NEWSWIRE) -- Ocugen, Inc. (NASDAQ: OCGN), a biopharmaceutical company focused on discovering, developing, and ...
By Ocugen, Inc.
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Bayer initiates phase III study to investigate aflibercept 8 mg in retinal vein occlusion
Global phase III QUASAR study will assess the efficacy and safety of aflibercept 8 mg in macular edema secondary to retinal vein occlusion (RVO) Study comes after positive data from the phase III PULSAR trial in neovascular (wet) age-related macular degeneration (nAMD) and phase II/III PHOTON trial in diabetic macular edema (DME) QUASAR is expected to enroll around 800 patients in 27 ...
By Bayer AG
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New data from pivotal studies with aflibercept 8 mg
New Subgroup and further analyses from PULSAR, PHOTON and CANDELA provide insights into durability results of extended treatment intervals, patient characteristics as well as efficacy and safety of intravitreal aflibercept 8 mg In total, 18 presentations on aflibercept 8 mg and Eylea (aflibercept 2 mg) reinforce Bayer’s commitment to advancing treatment of patients with exudative retinal ...
By Bayer AG
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Ocugen, Inc. Provides an Update on its Investigational New Drug Application with U.S. FDA to Initiate a Phase 3 Clinical Trial Evaluating COVID-19 Vaccine Candidate COVAXIN (BBV152)
MALVERN, Pa., Nov. 26, 2021 (GLOBE NEWSWIRE) -- Ocugen, Inc. (NASDAQ: OCGN), a biopharmaceutical company focused on discovering, developing, and commercializing novel therapeutics and vaccines, announced that the U.S. Food and Drug Administration (FDA) has issued a clinical hold on the Company’s Investigational New Drug application (IND) to evaluate the COVID-19 vaccine candidate, BBV152, ...
By Ocugen, Inc.
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COVAXIN (BBV152) Booster Dose Study Demonstrates Robust Immune Responses and Long-Term Safety
Participants receiving a booster dose six months after second dose of COVAXIN™ saw significant increase (>10-fold across Alpha, Beta, Delta and Delta Plus variants) in neutralizing titers compared to baseline at six months Persistence of memory B and T cell immune responses at six months post second dose Pronounced SARS-CoV-2-specific T cell response to COVAXIN™ before and ...
By Ocugen, Inc.
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Ocugen Partner, Bharat Biotech, Announces Positive Immunogenicity and Safety Data from COVAXIN (BBV152), COVID-19 Candidate Vaccine, in Children 2 – 18 YEARS
COVAXIN™ whole virus inactivated vaccine generated broad antibody response comparable to those seen in a large phase 3 trial in adults 18+ Adverse events were primarily mild, and no serious adverse events (SAEs) were noted Immunobridging trial demonstrated safety, reactogenicity and immunogenicity of COVAXIN™ in children from 2 years old and up No cases of myocarditis or blood ...
By Ocugen, Inc.
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