Bausch Health Initiates Second Phase 3 Study For NOV03 Investigational Treatment For Dry Eye Disease Associated With Meibomian Gland Dysfunction

LAVAL, Quebec, Nov. 24, 2020 /PRNewswire/ — Bausch Health Companies Inc. (NYSE/TSX: BHC) (“Bausch Health” or the “Company”) and Bausch + Lomb, its leading global eye health business, announced today that the Company has initiated the second of two Phase 3 studies evaluating the investigational treatment NOV03 (perfluorohexyloctane) as a first-in-class investigational drug with a novel mechanism of action to treat the signs and symptoms of Dry Eye Disease (DED) associated with Meibomian gland dysfunction (MGD). Enrollment of the first Phase 3 study is currently underway and has reached 85% of its enrollment goal.

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Sonja Kroesser named Top 25 Women Leaders in Biotechnology of 2022

Heidelberg, Germany, and Cambridge, MA, USA, November 15, 2022 – Novaliq, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics based on the unique EyeSol^® water-free technology, is proud to announce that today our own Sonja Kroesser, Vice President and Head of Preclinical and Clinical Development, was named as a Top 25 Women Leaders in Biotechnology of 2022 by the Healthcare Technology Report.

Novaliq announces FDA acceptance of the new drug application for CyclaSol^® for the treatment of dry eye disease

• PDUFA target action date is June 8, 2023

HEIDELBERG, Germany, and CAMBRIDGE, MA, USA, October 24, 2022 – 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).

FDA accepts NDA filing for NOV03

VAUGHAN, Ontario, and HEIDELBERG, Germany, Sept. 6, 2022 – 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 the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) filing for investigational treatment NOV03 (perfluorohexyloctane). A potential first-in-class eye drop with a novel mechanism of action, NOV03 is an investigational therapy to treat the signs and symptoms of dry eye disease (DED) associated with Meibomian gland dysfunction (MGD). NOV03 has been assigned a Prescription Drug User Fee Act (PDUFA) action date of June 28, 2023.

Dermaliq Therapeutics Announces First Patient Dosed in Phase 1b/2 Trial Evaluating DLQ02 for Treatment of Plaque Psoriasis

Wilmington, Delaware, August 18, 2022 – Dermaliq Therapeutics, Inc. (Dermaliq), a private, clinical stage pharmaceutical company with a focus on dermatology, today announced first patient dosed in a Phase 1b/2a trial with DLQ02, a topical calcineurin inhibitor. The trial is designed to evaluate the safety, systemic absorption, pharmacodynamics, and clinical efficacy of DLQ02 in patients with plaque psoriasis.

Novaliq submits New Drug Application seeking approval for first-of-a-kind Dry Eye Disease Treatment CyclASol^®

Heidelberg, Germany, and Cambridge, MA, USA, August 09, 2022 – Novaliq, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics based on the unique EyeSol^® water-free technology, today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for CyclASol^® (cyclosporine ophthalmic solution), a proposed novel treatment for the signs and symptoms of dry eye disease (DED).