Year: 2023

MIEBO is the First and Only Prescription Eye Drop Approved for Dry Eye Disease that Directly Targets Tear Evaporation, Based on Consistent Results from Two Consecutive Pivotal Phase 3 Trials

VAUGHAN, Ontario, and HEIDELBERG, Germany, May 18, 2023 – 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 approved MIEBO^TM (perfluorohexyloctane ophthalmic solution; formerly known as NOV03), for the treatment of the signs and symptoms of dry eye disease (DED). MIEBO is the first and only FDA-approved treatment for DED that directly targets tear evaporation.

Heidelberg, Germany, and Cambridge, MA, USA, April 12, 2023 – Novaliq, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics based on the unique EyeSol^® water-free technology, today announced that results from the second pivotal Phase 3 trial for CyclASol^®, ESSENCE-2, have been published in Journal of the American Medical Association (JAMA) Ophthalmology. CyclASol^® is currently under regulatory review for the treatment of signs and symptoms of dry eye disease (DED). The U.S. Food and Drug Administration (FDA) has assigned a Prescription Drug User Fee Act (PDUFA) action date of June 8, 2023.

Bausch + Lomb and Novaliq Announce Publication of Second Pivotal Phase 3 Data on NOV03 (Perfluorohexyloctane) in American Journal of Ophthalmology

NOV03 Consistently Met Primary Endpoints for Signs and Symptoms of Dry Eye Disease Associated with Meibomian Gland Dysfunction

NOV03 PDUFA Action Date is June 28, 2023

VAUGHAN, Ontario, and HEIDELBERG, Germany, March 22, 2023 – Bausch + Lomb Corporation (NYSE/TSX: BLCO) (“Bausch + Lomb”), a leading global eye health company dedicated to helping people see better to live better, today announced that American Journal of Ophthalmology has published results from MOJAVE, the second pivotal Phase 3 trial for NOV03 (perfluorohexyloctane). NOV03 is being investigated to treat the signs and symptoms of dry eye disease (DED) associated with Meibomian gland dysfunction (MGD). Results from the first pivotal Phase 3 trial, GOBI, were published earlier this year in Ophthalmology. The U.S. Food and Drug Administration (FDA) assigned NOV03 a Prescription Drug User Fee Act (PDUFA) action date of June 28, 2023.

March 27, 2023. Chengdu Shengdi Pharmaceutical Co., Ltd., a subsidiary of Jiangsu Hengrui Pharmaceuticals Co., Ltd. (“Hengrui Pharma”), recently received the “Notice of Acceptance” from the Chinese National Medical Products Administration (NMPA). The marketing authorization application for SHR8028 (cyclosporine ophthalmic solution) eye drops for the treatment of the signs and symptoms of dry eye disease was accepted by NMPA.

February 2, 2023. Chengdu Shengdi Pharmaceutical Co., Ltd., a subsidiary of Jiangsu Hengrui Pharmaceuticals Co., Ltd. (“Hengrui Pharma”), received the “Notice of Acceptance” from the Chinese National Medical Products Administration (NMPA). The marketing authorization application for SHR8058 (perfluorohexyloctance) eye drops was accepted for the treatment of dry eye disease associated with Meibomian gland dysfunction by NMPA.

• CHMP determined CyclASol is eligible for a centralised procedure
• Novaliq has submitted a Letter of intent to file a Marketing Authorisation Application (MAA) in July 2023

Heidelberg, Germany, and Cambridge, MA, USA, Feb 8, 2023 – Novaliq, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics based on the unique EyeSol^® water-free technology, today announced its plans for filing a Marketing Authorisation Application (MAA) for CyclASol^® (ciclosporin ophthalmic solution), a first-of-its-kind anti-inflammatory product for the treatment of dry eye disease (DED) in the European Union.

NOV03 is Being Investigated to Treat the Signs and Symptoms of Dry Eye Disease Associated with Meibomian Gland Dysfunction

NOV03 PDUFA Action Date is June 28, 2023

VAUGHAN, Ontario, and HEIDELBERG, Germany, Jan. 4, 2023 – 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).