China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) has announced that a market approval filing for SHR8028, an anti-inflammatory and immunomodulatory agent under development to treat dry eye, has been accepted for review by the National Medical Products Administration (NMPA) in China.
Clinical Study and Results
The filing is based on a multi-center, randomized, double-blind, excipient parallel controlled Phase III study that assessed SHR8028’s safety and efficacy in treating 206 dry eye sufferers. The study achieved its primary endpoint by May 2022, with SHR8028 eye drops significantly improving the symptoms and signs of dry eye in patients, while maintaining a good local tolerability profile. The incidence of adverse events and local sensory abnormalities after administration of SHR8028 eye drops was comparable to that of excipients.
Global Context and Commercial Potential
SHR8028, also known as Cyclasol (0.1% cyclosporine A preparation), was in-licensed from German firm Novaliq GmbH in September 2019 and is currently awaiting regulatory decisions by the US FDA. Commercially available cyclosporine A eye drops for dry eye include Allergen’s Restasis (0.05%, emulsion), Sun Pharma’s Cequa (0.09%, nano micellar aqueous solution), Santen Pharma’s Ikervis (0.1%, cationic nanoemulsion), and Cyporin (0.05%, nano aqueous solution), as well as Xingqi Pharma’s Category III generic cyclosporine eye drops (II), which generated a combined USD 2.683 billion in global sales in 2021. This highlights the significant market potential for SHR8028 in the dry eye treatment space.-Fineline Info & Tech
