Santen Inc., the U.S. subsidiary of Santen Pharmaceutical Co., and Ube Corp. have received FDA approval for their Omlonti 0.002 percent eye drops, which are designed to reduce elevated intraocular pressure in glaucoma patients.
Omlonti was launched internationally in 2018, and is used in five countries worldwide.
It has shown success in reducing intraocular pressure by 5 to 7 millimeters of mercury over a 12-month period, according to the company.
"This approval is an important milestone in our ambition to tackle unmet needs in eye health and advances our goal of realization of 'Happiness with Vision'. It also represents our first glaucoma offering in the U.S.," Peter Sallstig, MD, chief medical officer at Santen, said in a Sept. 26 press release. "We are pleased to provide doctors and patients in the U.S. with a new option to help control intraocular pressure for the more than three million Americans affected by glaucoma or ocular hypertension."