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Novartis announces FDA and EMA filing acceptances of Beovu® for patients with diabetic macular edemaBasel, October 13, 2021 — Novartis today announced that the US Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) and that the European Medicines Agency (EMA) has validated the type-II variation application for Beovu® (brolucizumab) 6 mg for the treatment of diabetic macular edema (DME…OphthalmologyEye Care
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Novartis is working with partners around the world to help eliminate preventable visual impairment and blindness by reimagining access to eye care.Access to HealthcareEye CareEye DisordersOphthalmology -
Eyesight initiatives are restoring vision – and hope – to thousands of people in Southeast Asia by expanding equitable access to eye care.
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Basel, August 17, 2021 — Novartis today announced positive results from two Phase III clinical trials assessing Beovu® (brolucizumab) 6 mg versus aflibercept 2 mg in patients with diabetic macular edema (DME). Year two of the pivotal KITE* trial evaluated Beovu on up to 16-week dosing intervals, and the one-year KINGFISHER study evaluated Beovu…OphthalmologyEye Care
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Basel, 21. September 2021 — Novartis hat heute die Übernahme von Arctos Medical bekanntgegeben. Das Unternehmen erweitert dadurch sein Portfolio in der Augenheilkunde um das präklinische AAV*-Gentherapieprogramm sowie die entsprechende Technologie von Arctos. Die Übernahme unterstreicht das Engagement von Novartis, Behandlungsmöglichkeiten für…OphthalmologyEye CareCell and Gene Therapy
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Bâle, le 21 septembre, 2021 — Novartis a annoncé aujourd’hui avoir acquis Arctos Medical, ajoutant à son portefeuille d’ophtalmologie un programme préclinique de thérapie génique AAV basé sur l’optogénétique et la technologie exclusive d’Arctos. Cette acquisition souligne l’engagement de Novartis dans la recherche de traitements pour les patients…OphthalmologyEye CareCell and Gene Therapy
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Basel, September 21, 2021 — Novartis today announced that it has acquired Arctos Medical, adding a pre-clinical optogenetics-based AAV gene therapy program and Arctos’ proprietary technology to its ophthalmology portfolio. The acquisition underscores the Novartis commitment to finding treatments for patients with vision loss and the potential of…OphthalmologyEye CareCell and Gene Therapy
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Basel, October 5, 2020 — Novartis today announced that results of two new post-hoc analyses of the Phase III HAWK and HARRIER clinical trials in wet age-related macular degeneration (AMD) were presented at the EURETINA 2020 virtual congress. The first analysis demonstrated fewer Beovu® (brolucizumab) patients had early persistent fluid, defined as…Reimagine MedicineOphthalmologyEye Care
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Basel, November 13, 2020 — Novartis today reported initial findings from a coalition convened to answer key questions related to treatment with Beovu® (brolucizumab) for adults with wet age-related macular degeneration (AMD). Analyses of US real-world and Phase III data presented at the American Academy of Ophthalmology (AAO) 2020 Annual Meeting…Reimagine MedicineOphthalmologyEye Care
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Basel, December 15, 2020 — Novartis today announced positive findings from the first interpretable results of the Phase III KESTREL study, assessing the efficacy and safety of Beovu® (brolucizumab) 3 mg and 6 mg in diabetic macular edema (DME). Following KITE*, KESTREL is the second pivotal Phase III study of Beovu in DME. The trial met its…Reimagine MedicineOphthalmologyEye Care
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Basel, May 1, 2021 — Novartis today announced positive one-year results of the Phase III KESTREL and KITE* studies, evaluating the efficacy and safety of Beovu® (brolucizumab) 6 mg in diabetic macular edema (DME). Both studies met their primary endpoints of non-inferiority in change in best corrected visual acuity (BCVA) from baseline for Beovu 6…OphthalmologyEye CareDrug Discovery
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Basel, May 28, 2021 — Today, Novartis reported the first interpretable year one results of the Phase III MERLIN study, a two-year study initiated in H2 2018, assessing the efficacy and safety of Beovu® (brolucizumab) 6 mg versus aflibercept 2 mg given every four weeks following the loading phase in patients with wet age-related macular…OphthalmologyEye Care