Key Takeaways

  • China's NMPA approved Heng Yi (0.1% cyclosporine ophthalmic solution) for dry eye disease, marking the first approved water-free cyclosporine ophthalmic solution in the country
  • Phase 3 data demonstrated significant improvements in corneal staining by Day 15 and Day 29, with a favorable safety and tolerability profile in patients with moderate-to-severe DED

Hengrui Pharma has received approval from China's National Medical Products Administration (NMPA) for Heng Yi (0.1% cyclosporine ophthalmic solution), expanding treatment options for patients with dry eye disease in one of the world's largest ophthalmic markets.

The approval covers use of the topical therapy to increase tear secretion in patients with reduced tear production and improve signs of dry eye disease. The product was developed through a collaboration between Hengrui Pharma and Germany-based Novaliq, which licensed exclusive rights to develop, manufacture, and commercialize the therapy in China to Hengrui in 2019.

Heng Yi is the first approved water-free 0.1% cyclosporine ophthalmic solution and becomes the second dry eye therapy in China based on Novaliq's EyeSol water-free drug delivery platform. It follows the 2025 approval of Heng Qin (perfluorohexyloctane ophthalmic solution).

The newly approved formulation combines cyclosporine with perfluorobutylpentane, a water-free semifluorinated alkane vehicle designed to enhance ocular surface spreading while reducing friction.

The NMPA decision was supported by results from the multicenter, randomized, double-blind, vehicle-controlled Phase 3 SHR8028-301 trial conducted in China. The study enrolled 206 adults with moderate-to-severe dry eye disease, who were randomized 1:1 to receive either the investigational therapy or vehicle twice daily. Co-primary endpoints evaluated changes in total corneal fluorescein staining (tCFS) and eye dryness visual analog scale scores at Day 29.

According to the companies, treatment produced statistically significant improvements in corneal staining as early as Day 15, with mean tCFS reductions of 4.0 points in the treatment group compared with 2.8 points in the vehicle group (P=0.008). By Day 29, mean reductions reached 4.8 points versus 3.0 points, respectively (P<0.0001). The therapy also demonstrated a favorable safety and tolerability profile.

The Chinese study served as a bridging trial to Novaliq's global ESSENCE-2 phase 3 program. ESSENCE-2 enrolled 834 patients in the United States and similarly evaluated twice-daily treatment with the cyclosporine formulation versus vehicle. The trial met its primary sign endpoint, demonstrating significant improvements in corneal staining beginning at Day 15. More than 70% of treated patients achieved a clinically meaningful improvement of at least three grades in total corneal staining within four weeks, according to the study results. Long-term findings from the ESSENCE-2 open-label extension study also supported sustained efficacy, with more than 80% of participants maintaining clinically meaningful improvements in corneal staining over 12 months of treatment.

The therapy, developed globally as CyclASol, was approved by the US FDA in 2023 for the treatment of the signs and symptoms of dry eye disease. It subsequently received centralized approval from the European Commission in 2024 for adults with moderate-to-severe dry eye disease.