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La FDA autorise la première lentille de contact à profondeur de champ étendue pour la presbytie

BOCA RATON, Floride--(BUSINESS WIRE)--Cataltheia Group et sa filiale américaine Bruno Vision Care LLC, leader dans le domaine de l’innovation en matière de santé oculaire, ont annoncé aujourd’hui que la Food and Drug Administration (FDA) américaine avait autorisé la première et unique lentille de contact souple (hydrophile) jetable à usage quotidien pour la presbytie utilisant la technologie optique brevetée Extended Depth of Focus (EDOF), permettant ainsi sa commercialisation aux États-Unis. D...
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L'FDA approva le prime lenti a contatto con profondità di focalizzazione estesa per la presbiopia

BOCA RATON, Fla.--(BUSINESS WIRE)--The Cataltheia Group e la sua controllata, Bruno Vision Care LLC, azienda leader nell'innovazione della salute degli occhi, oggi ha annunciato che la Food and Drug Administration (FDA) statunitense ha approvato la prima e unica Daily Disposable Soft (Hydrophilic) Contact Lens per la presbiopia che utilizza la tecnologia brevettata di progettazione ottica Extended Depth of Focus (EDOF), dando il via alla distribuzione commerciale negli Stati Uniti. Deseyne® off...
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La FDA autoriza la primera lente de contacto con profundidad de foco extendida para la presbicia

BOCA RATÓN, Florida--(BUSINESS WIRE)--Cataltheia Group y su filial en los Estados Unidos, Bruno Vision Care LLC, líder en innovación en salud ocular, anunciaron hoy que la Administración de Alimentos y Medicamentos de los Estados Unidos (FDA) ha autorizado la primera y única lente de contacto blanda (hidrofílica) diaria y desechable para la presbicia que utiliza una tecnología óptica patentada de profundidad de foco extendida (EDOF, por sus siglas en inglés), cuya distribución comercial ahora s...
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FDA keurt eerste Extended Depth of Focus-contactlens voor presbyopie goed

BOCA RATON, Fla.--(BUSINESS WIRE)--De Cataltheia Group en Bruno Vision Care LLC, de Amerikaanse dochteronderneming van het bedrijf en leider op gebied van innovatie voor de gezondheid van de ogen, maakten vandaag bekend dat de Amerikaanse FDA (U.S. Food & Drug Administration) de eerste en enige Daily Disposable Soft (hydrofiele) contactlens voor presbyopie heeft goedgekeurd, een contactlens die gebruik maakt van de gepatenteerde EDOF (Extended Depth of Focus) optische ontwerptechnologie. Da...
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FDA genehmigt erste Kontaktlinse mit erweiterter Tiefenschärfe für Presbyopie

BOCA RATON, Fla.--(BUSINESS WIRE)--Die Cataltheia Group und ihre US-Tochtergesellschaft Bruno Vision Care LLC, ein führendes Unternehmen im Bereich der Augenheilkunde, gaben heute bekannt, dass die US-amerikanische Arzneimittelbehörde FDA (Food and Drug Administration) die erste und einzige weiche (hydrophile) Einweg-Tageskontaktlinse für Presbyopie zugelassen hat, die die patentierte optische EDOF-Technologie (Extended Depth of Focus) nutzt und damit den kommerziellen Vertrieb in den Vereinigt...
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FDA Clears First Extended Depth of Focus Contact Lens for Presbyopia

BOCA RATON, Fla.--(BUSINESS WIRE)--The Cataltheia Group and its U.S. subsidiary, Bruno Vision Care LLC, a leader in eye health innovation, today announced that the U.S. Food and Drug Administration (FDA) has cleared the first and only Daily Disposable Soft (Hydrophilic) Contact Lens for Presbyopia utilizing patented Extended Depth of Focus (EDOF) optical design technology, enabling commercial distribution in the United States. Deseyne® delivers smooth, continuous focus across near, intermediate...
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Bausch + Lomb to Participate in the 44th Annual J.P. Morgan Healthcare Conference

VAUGHAN, Ontario--(BUSINESS WIRE)--Bausch + Lomb Corporation (NYSE/TSX: BLCO), a leading global eye health company dedicated to helping people see better to live better, today announced that Chairman and CEO Brent Saunders, Executive Vice President and Chief Financial Officer Sam Eldessouky and Chief Medical Officer and Head of Research & Development Yehia Hashad, MD, will participate in a company presentation at the 44th Annual J.P. Morgan Healthcare Conference on Monday, Jan. 12, 2026, at...
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GenSight Biologics Announces Regulatory Authorization for Early Access Treatment with GS010/LUMEVOQ® in Israel

PARIS--(BUSINESS WIRE)--Regulatory News: GenSight Biologics (Euronext: SIGHT, ISIN: FR0013183985, PEA-PME eligible), a biopharma company focused on developing and commercializing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders, today announced that Israel’s Ministry of Health Pharmaceutical Division has authorized the use of the candidate gene therapy GS010/LUMEVOQ®1 for the early access treatment of individual patients in the country. Early...
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Viridian Therapeutics Announces BLA Acceptance and Priority Review for Veligrotug for the Treatment of Thyroid Eye Disease

WALTHAM, Mass.--(BUSINESS WIRE)--Viridian Therapeutics, Inc. (Nasdaq: VRDN), a biotechnology company focused on discovering, developing, and commercializing potentially best-in-class medicines for serious and rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for veligrotug for the treatment of thyroid eye disease (TED). The application has been granted Priority Review, with a Prescription Drug User Fee Act (PDUFA...
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GenSight Biologics Announces the Granting of Compassionate Use Authorization (CUA/AAC) for GS010/LUMEVOQ® in France

PARIS--(BUSINESS WIRE)--Regulatory News: GenSight Biologics (Euronext: SIGHT, ISIN: FR0013183985, PEA-PME eligible), a biopharma company focused on developing and commercializing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders, today announced that the French medicines safety agency ANSM (Agence nationale de sécurité du médicament et des produits de santé) has granted compassionate use authorization (Autorisation d’Accès Compassionnel, or AA...