–Innovative product SDN-037 eye drops shows positive top-line results from the pivotal Phase 3 clinical trial in USA. The trial met its pre-specified primary and secondary objectives, and SDN-037 was generally well-tolerated in this study.
On October 14, 2020, Sun Pharma Advanced Research Company Ltd. (“SPARC”), the collaborative partner of China Medical System Holdings Limited (“CMS”), reported positive top-line results from its Phase 3 trial for products SDN-037, the eye drops for the treatment of Inflammation and Pain associated with Ocular Surgery. The trial met its pre-specified primary and secondary objectives, SDN-037 was generally well-tolerated in this study with adverse events consistent with the known safety profile of difluprednate.
The objective of the trial was to assess the efficacy and safety of SDN-037 in clearing the inflammation and pain. Compared to vehicle, patients treated with SDN-037 showed statistically significant differences in the primary efficacy measure and key secondary endpoint of the trial.
According to statistics, in 2016, ophthalmic surgery discharged 4.7 million patients nationwide, and the total cases of cataract surgery were 2.3 million, and refractive surgery a million. Currently marketed steroidal eye drops require administration every 4 to 6 hours, but SDN-037 is administered only twice a
day, which improves the dosing convenience. Meanwhile, the formulation of SDN-037 is clear compared to marketed formulation which is milky resulting in blurring of vision after administration. There is currently no preparation of the reference steroid in Mainland China. If marketed, this product is expected
to become an exclusive product.
CMS, through its wholly-owned subsidiary, acquired the product rights of SDN-037 eye drops in Mainland China, Hong Kong, Macao and Taiwan from SPARC in November 2019.
Further information can be found in the SPARC’s Press Release：