Year: 2023

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).

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).

Senju Pharmaceutical and Novaliq Enter Into License Agreement For NOV03 (Perfluorohexyloctane Ophthalmic Solution) For the Treatment of Dry Eye Disease in Japan

Osaka, Japan & Heidelberg, Germany, and Cambridge, MA, USA, June 13, 2023 – Senju Pharmaceutical Co., Ltd., a researched-based Japanese pharmaceutical company focusing the field of ophthalmology, and Novaliq GmbH, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics based on its unique EyeSol^® water-free technology, are pleased to announce the closing of a license agreement on Japan rights to develop, manufacture, and commercialize NOV03 (perfluorohexyloctane ophthalmic solution), the first and only prescription treatment for signs and symptoms of dry eye disease that directly targets tear evaporation.

Novaliq Announces FDA Approval of VEVYE^™ (Cyclosporine Ophthalmic Solution) 0.1% for the Treatment of the Signs and Symptoms of Dry Eye Disease

VEVYE^™ is the first and only cyclosporine solution indicated for the treatment of signs and symptoms of dry eye disease with efficacy demonstrated after 4 weeks

Heidelberg, Germany and Cambridge, MA, USA, June 8, 2023 – 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 VEVYE^™ (cyclosporine ophthalmic solution) 0.1% for the treatment of the signs and symptoms of dry eye disease. VEVYE (development name CyclASol^®) is the first and only cyclosporine solution indicated for the treatment of signs and symptoms of dry eye disease with efficacy demonstrated after 4 weeks of treatment.

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).