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Bausch + Lomb Announces Statistically Significant Topline Results from the Second Phase 3 Trial Of NOV03 (perfluorohexyloctane) in Dry Eye Disease Associated with Meibomian Gland Dysfunction
Bausch + Lomb Announces Statistically Significant Topline Results from the Second Phase 3...
About this update from Bausch Health Companies Inc.
[{"type":"text","content":"\n \n \n \n Bausch + Lomb Announces Statistically Significant Topline Results from the Second Phase 3 Trial Of NOV03 (perfluorohexyloctane) in Dry Eye Disease Associated with Meibomian Gland Dysfunction\n \n \n /* Style Definitions */\nspan.prnews_span\n{\nfont-size:8pt;\nfont-family:\"Arial\";\ncolor:black;\n}\na.prnews_a\n{\ncolor:blue;\n}\nli.prnews_li\n{\nfont-size:8pt;\nfont-family:\"Arial\";\ncolor:black;\n}\np.prnews_p\n{\nfont-size:0.62em;\nfont-family:\"Arial\";\ncolor:black;\nmargin:0in;\n}\n \n \n \n \n \n \n All Primary and Secondary Endpoints Were Achieved\n \n \n Bausch + Lomb Plans to Submit NDA to FDA in 2022\n \n \n PR Newswire\n \n \n \n \n \n LAVAL, QC\n \n and\n \n HEIDELBERG\n \n ,\n \n Germany\n \n ,\n \n Sept. 30, 2021\n \n /PRNewswire/ -- Bausch + Lomb, a leading global eye health business of Bausch Health Companies Inc. (NYSE/TSX: BHC) (\"Bausch Health\") and Novaliq GmbH (\"Novaliq\"), a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics, today announced statistically significant topline data from the second Phase 3 (MOJAVE) trial evaluating the investigational drug NOV03 (perfluorohexyloctane) as a first-in-class eye drop with a novel mechanism of action to treat the signs and symptoms of dry eye disease (DED) associated with Meibomian gland dysfunction (MGD). The companies announced statistically significant topline data from the first Phase 3 trial (GOBI trial) in April 2021.\n \n \n \"The findings from this second Phase 3 trial reinforce the results of the first Phase 3 trial and further supports the efficacy and safety profile of NOV03 as a potential important new treatment option for the millions of people living with dry eye disease associated with MGD,\" said\n \n Joseph C. Papa\n \n , chairman and CEO,\n \n Bausch Health\n \n . \"These results mark another important milestone in bringing NOV03 to market as a potential first-in-class treatment, and we anticipate filing a New Drug Application to the U.S. Food and Drug Administration in 2022.\"\n \n \n Dry eye disease is one of the most common ocular surface disorders, causing discomfort for millions of Americans. MGD is a major cause of the development and progression of evaporative DED, which is caused by a deficient tear film lipid layer that leads to increased tear evaporation.\n \n 1,2\n \n \n \n The ...