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Nicox Focuses Research Activities on Novel NO-Donating PDE5 Inhibitors for Glaucoma and Enters into Collaboration with Novaliq on Innovative Topical Ophthalmic Formulations

Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, today announced that it will be focusing its research activities on topical nitric oxide (NO)-donating phosphodiesterase-5 (PDE5) inhibitors and soluble guanylate cyclase (sGC) stimulators. As part of this focus, Nicox has entered into a research collaboration with Novaliq GmbH for the development of novel topical ophthalmic formulations of Nicox’s NO-donating PDE5 inhibitors based on Novaliq’s water-free enabling EyeSol® technology, for lowering intraocular pressure (IOP).

Read the full story at Nicox.com

Bausch + Lomb and Novaliq Announce FDA Approval of MIEBOTM (Perfluorohexyloctane Ophthalmic Solution) for the Treatment of the Signs and Symptoms of Dry Eye Disease

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 MIEBOTM (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.

Novaliq announces publication of second pivotal phase 3 trial data on CyclASol® 0.1% (Cyclosporine Ophthalmic Solution) in JAMA Ophthalmology

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.

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

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.

Marketing Authorization Application for Dry Eye Disease Drug SHR8028 (Cyclosporine Ophthalmic Solution) developed by Jiangsu Hengrui Pharmaceutical has been accepted in the People’s Republic of China

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.

Jiangsu Hengrui Pharmaceuticals’ Marketing Authorization Application for Innovative Drug SHR8058 (Perfluorohexyloctane) for the Treatment of Dry Eye Disease has been accepted in the People’s Republic of China

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.