-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£º
https://www.sparc.life/sites/default/files/2020-10/SDN037_topline_results_release_final_14th_Oct.pdf