NOV03*
Potentially, first and only drug to treat dry eye disease (DED) associated with Meibomian gland dysfunction (MGD)
NOV03 (100% perfluorohexyloctane) is the first drug developed to treat dry eye disease (DED) associated with Meibomian gland dysfunction in a highly effective way.
What are the benefits of NOV03?
NOV03 has a unique mode-of-action: It stabilizes the lipid layer that protects the tear film for hours and has the ability to penetrate the Meibomian glands.
It is the first drug, based on a water-free technology, that is designed to prevent excessive tear evaporation and to restore tear film balance.
NOV03 can penetrate Meibomian glands and potentially dissolve thickened Meibum, thereby improving Meibomian gland function
Clinical Trials conclude the efficacy and safety
The SEECASE-1 trial (NCT03333057) showed unprecedented sign and symptom improvements for patients with DED associated with MGD.
The drug has an impressive effect on a variety of symptoms, an early onset of action and treats signs and symptoms of DED.
What is the regulatory status of NOV03?
Based on the data of the SEECASE-1 trial, Novaliq has accelerated its development program to make a drug treatment with NOV03 available soon.
The final pivotal clinical trial (SEECASE-2, NCT04139798) will start in 2019, leading to NDA submission in 2021.
*
- In December 2019, Bausch Health (NYSE/TSX: BHC) and Bausch + Lomb, its leading global eye health business, announced the acquisition of an exclusive license for the commercialization and development of NOV03 in the United States and Canada.
Under the terms of the licensing agreement, Bausch Health has the right to pursue development and commercialization of NOV03 for DED and combination products based on NOV03 in additional ophthalmic indications in the United States and Canada. - In November 2019, Jiangsu Hengrui Medicine (SHA 600276) announced the closing of an exclusive license agreement to develop, manufacture, and commercialize NOV03 and CyclASol® for the treatment of dry eye disease in People’s Republic of China including mainland China, Hong Kong, Macau and Taiwan. Jiangsu Hengrui Medicine will be responsible for all development, regulatory and commercialization activities and related expenses in the territory.
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