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

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

Harrow , 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 twice-daily (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).

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

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

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.

NOVALIQ ANNOUNCES PUBLICATION OF SECOND PIVOTAL PHASE 3 TRIAL DATA ON CYCLASOL 0.1% (CYCLOSPORINE OPHTHALMIC SOLUTION) IN JAMA OPHTHALMOLOGY (English only)

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.

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 (English only)

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.

The marketing authorization application is based on a multi-center, randomized, vehicle-controlled, double-blind, phase 3 clinical study (study number SHR8028-301). The results showed that SHR8028 eye drops, compared to its vehicle, significantly improved the signs and symptoms of dry eye disease. At the same time, SHR8028 eye drops were safe, reliable, and well tolerated. The incidence of adverse events and local instillation site reactions after taking the drops were comparable between SHR8028 and the vehicle.

Bausch + Lomb and Novaliq Announce Publication of Pivotal Phase 3 Data on NOV03 (Perfluorohexyloctane) in Ophthalmology (English only)

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

Bausch + Lomb Corporation (“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). NOV03 is being investigated to treat the signs and symptoms of dry eye disease (DED) associated with Meibomian gland dysfunction (MGD). The U.S. Food and Drug Administration (FDA) assigned NOV03 a Prescription Drug User Fee Act (PDUFA) action date of June 28, 2023.