European Medicines Agency Accepts Novaliq’s Marketing Authorization Application for CyclASol® (ciclosporin ophthalmic solution) 0.1% for the Treatment of Dry Eye Disease
Harrow Acquires U.S. and Canadian Commercial Rights to VEVYE® (Cyclosporine Ophthalmic Solution) 0.1% from Novaliq
OSAKA, Japan & HEIDELBERG, Germany & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Fifth paragraph, the number in the quote should read: 10 million units sold instead of 10,000 million units sold.
HEIDELBERG, Germany and CAMBRIDGE, MA, USA--(BUSINESS WIRE)--Novaliq GmbH, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has approved VEVYE™ (cyclosporine ophthalmic solution) 0.1% for the treatment of the signs and symptoms of dry eye disease. VEVYE (development name CyclASol®) is the first and only cyclosporine solution indicated for the treatment of signs and symptoms of dry eye disease with efficacy demonstrated after 4 weeks of treatment.
Bausch + Lomb and Novaliq secured an approval for their dry eye disease drop on Thursday, to be marketed as Miebo.
HEIDELBERG, Germany & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Novaliq, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics based on the unique EyeSol® water-free technology, today announced the presentation of new data on the investigational new drug treatment, CyclASol® 0.1% (cyclosporine ophthalmic solution), during the American Society of Cataract and Refractive Surgery (ASCRS) annual meeting, which will take place in San Diego from May 5-8, 2023.
Novaliq Announces Publication of Second Pivotal Phase 3 Trial Data on CyclASol 0.1% (Cyclosporine Ophthalmic Solution) in JAMA Ophthalmology
Novaliq Plans to File a Markting Authorisation Application for CyclASol® in the E.U. for the Treatment of Dry Eye Disease in July 2023
VAUGHAN, Ontario & HEIDELBERG, Germany--(BUSINESS WIRE)--Bausch + Lomb Corporation (NYSE/TSX: BLCO) (“Bausch + Lomb”), a leading global eye health company dedicated to helping people see better to live better, and Novaliq GmbH, a biopharmaceutical company focusing on first- and best-in class ocular therapeutics, today announced that Ophthalmology, the peer-reviewed journal of the American Academy of Ophthalmology, has published results from the pivotal Phase 3 trial GOBI, which is one of two pivotal Phase 3 trials for NOV03 (perfluorohexyloctane). NOV03 is being investigated to treat the signs and symptoms of dry eye disease (DED) associated with Meibomian gland dysfunction (MGD). The U.S. Food and Drug Administration (FDA) assigned NOV03 a Prescription Drug User Fee Act (PDUFA) action date of June 28, 2023.
HEIDELBERG, Germany, and CAMBRIDGE, MA, USA--(BUSINESS WIRE)--Novaliq, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics based on the unique EyeSol® water-free technology, today announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for CyclASol® (cyclosporine ophthalmic solution), a first-of-its-kind anti-inflammatory product for the treatment for the signs and symptoms of dry eye disease (DED).