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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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Breakthrough in Ophthalmology! Hengrui’s Heng Qin® (Perfluorohexyloctane Eye Drops) Approved as First Treatment for Dry Eye Disease Associated with MGD

JIANGSU, China and HEIDELBERG, Germany, and CAMBRIDGE, MA, USA, July 8th, 2025 – Jiangsu Hengrui Pharmaceuticals Co., Ltd. (“Hengrui Pharma”), a global pharmaceutical company focused on scientific and technological innovation, and Novaliq GmbH (“Novaliq”), a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics based on the unique EyeSol® water-free technology, announce today that the China National Medical Products Administration (NMPA) has approved Heng Qin® (Perfluorohexyloctane Eye Drops) for the treatment of dry eye disease (DED) associated with Meibomian gland dysfunction (MGD). Heng Qin® is the first and only drug approved to treat DED associated with MGD and will be available to patients in China in the coming months.

Novaliq and Laboratoires Théa Announce Partnership and EU Approval for Vevizye (Ciclosporin 0.1% Eye Drops Solution)

Heidelberg, Germany, Cambridge, MA, USA, and CLERMONT-FERRAND, France, October 2, 2024 – Novaliq, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics based on the unique EyeSol® water-free technology, and Laboratoires Théa (Théa), the leading independent eye care group in Europe, announce European Commission approval of Vevizye® (ciclosporin 0.1% eye drops solution) in Europe and the closing of a partnership under which Théa has acquired the rights to commercialise the product in Europe and selected countries in the Middle East and North Africa (MENA).

Novaliq Receives Positive CHMP Opinion FOR Vevizye® in Dry EYE Disease

Heidelberg, Germany, and Cambridge, MA, USA, July 29, 2024 – Novaliq, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics based on the unique EyeSol® water-free technology, announces that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the granting of a marketing authorisation in the European Union for Vevizye®, intended for the treatment of moderate to severe dry eye disease in adult patients, which has not improved despite treatment with tear substitutes.

European Medicines Agency Accepts Novaliq’s Marketing Authorization Application for CyclASol® (Ciclosporin eye drops, solution 1 mg/mL) for the Treatment of Dry Eye Disease

Heidelberg, Germany, and Cambridge, MA, USA, August 24, 2023 – Novaliq GmbH, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics, today announced that the European Medicines Agency (EMA) has accepted the marketing authorization application (MAA) for CyclASol (ciclosporin ophthalmic solution) for regulatory review. CyclASol is an investigational new drug treatment for dry eye disease in patients not responding to tear substitutes. The Committee for Medicinal Products for Human Use (CHMP) of the EMA will start its review of the MAA under the centralized procedure for all 27 member states of the European Union (EU).

Harrow Acquires U.S. and Canadian Commercial Rights to VEVYE® (Cyclosporine Ophthalmic Solution) 0.1% from Novaliq

VEVYE® is the First and Only Cyclosporine-Based Product Indicated for the Treatment of Both Signs and Symptoms of Dry Eye Disease with Efficacy Demonstrated After Four Weeks VEVYE® is the Only Water-Free Ophthalmic Product with Convenient Twice-Daily (BID) Dosing NASHVILLE, Tenn. & HEIDELBERG, Germany, July 18, 2023 – Harrow (Nasdaq: HROW), a leading U.S. eyecare pharmaceutical company, and Novaliq GmbH, a German biopharmaceutical company focusing on first- and best-in-class ocular therapeutics, today announced an agreement under which Harrow will acquire the U.S. and Canadian commercial rights for VEVYE® (cyclosporine ophthalmic solution) 0.1%, a patented, non-preserved, ophthalmic solution prescription drug based on Novaliq’s proprietary EyeSol® water-free technology. VEVYE, which is dispensed topically in a unique 10 microliter per one drop and is labeled for twicedaily (BID) dosing, is the first and only cyclosporine-based product indicated for the treatment of both signs and symptoms of dry eye disease (DED). VEVYE was approved on May 30, 2023, by the U.S. Food and Drug Administration (FDA).