SDN-37 is a novel long-acting (twice-a-day) steroid ophthalmic formulation approved by the U.S. FDA. 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 and resulting in blurring of vision after administration.
In October 2020, the Group’s partner SPARC announced that the U.S. pivotal phase III clinical trial of SDN-37 had achieved positive top-line results, which met the primary and secondary objectives and SDN-037 was generally well tolerated in the study.
According to statistics, in China, ophthalmic surgery discharged 4.7 million patients in 2016, and the total cases of cataract surgery were 2.3 million, and refractive surgery 1 million. As there is currently no preparation of the reference steroid in Mainland China, the product is expected to provide a novel treatment option for patients.