Recently, Chengdu Shengdi Pharmaceutical Co., Ltd., a subsidiary of Hengrui Medicine, received approval from the National Medical Products Administration for its perfluorohexyloctane ophthalmic solution. This product is indicated for the treatment of dry eye disease associated with meibomian gland dysfunction, offering a brand-new pharmaceutical treatment option for patients in China.
According to the "Chinese Dry Eye Clinical Diagnosis and Treatment Guidelines (2023)", the prevalence of dry eye in China ranges from 21% to 30%. Results from a clinical study show that 69%–86% of individuals with dry eye suffer from meibomian gland dysfunction. This highlights the critical importance of targeting meibomian gland dysfunction when treating dry eye disease. As stated in the "Chinese Expert Consensus on Diagnosis and Treatment of Meibomian Gland Dysfunction (2023)", the current foundational therapy for meibomian gland dysfunction consists of physical treatments. Among existing pharmacological options across five categories, none directly targets meibomian gland dysfunction. Therefore, there is an urgent clinical need for a targeted, effective, and safe drug for dry eye disease associated with meibomian gland dysfunction.
In 2019, Hengrui Medicine introduced perfluorohexyloctane ophthalmic solution from Novaliq GmbH and holds exclusive rights to the product in China. This ophthalmic solution is developed based on EyeSol®, the world's first anhydrous drug delivery technology platform. It consists of a single component, perfluorohexyloctane (F6H8), is water‑free, and contains no oils, surfactants, preservatives, or other excipients. With extremely low surface tension, it rapidly spreads over the ocular surface, improves the lipid layer grade, inhibits tear evaporation, and promotes corneal epithelial repair. Additionally, perfluorohexyloctane ophthalmic solution replenishes non‑polar lipid components, increases tear film thickness, unblocks meibomian glands, and improves meibum secretion. Given its unique innovation and urgent clinical need, Hengrui Medicine, based on China's clinical development requirements and practices, conducted complete pivotal clinical trials in accordance with innovative drug technical standards. The New Drug Application was submitted to the NMPA in February 2023 and accepted for review.
The recent domestic approval of this product is supported by a pivotal, multicenter, randomized, double‑blind, parallel‑group, vehicle‑controlled Phase III clinical study. Study results demonstrate that compared to vehicle (placebo), perfluorohexyloctane ophthalmic solution is effective in treating dry eye disease associated with meibomian gland dysfunction. This brings a novel therapeutic option to Chinese patients suffering from dry eye.