FDA approves drop to lower IOP in patients with glaucoma
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Santen and UBE announced the FDA approval of Omlonti for the reduction of elevated IOP in patients with primary open-angle glaucoma or ocular hypertension.
The FDA granted the approval on Sept. 22, according to the agency’s website.
Omlonti (omidenepag isopropyl ophthalmic solution 0.002%) was jointly developed by Santen and UBE, according to a press release from Santen. The active ingredient, omidenepag isopropyl, which was developed by UBE, is a relatively selective prostaglandin EP2 receptor agonist that increases aqueous humor drainage through the trabecular and uveoscleral outflow pathways.
Omlonti was launched in Japan as Eybelis ophthalmic solution 0.002% in November 2018 and released in five other countries and regions since February 2021, according to the release.
This is Santen’s first glaucoma product in the U.S., Santen chief medical officer Peter Sallstig said in the release.
“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,’” Sallstig said.
“UBE Corp. is committed to working on new drug discoveries on a daily basis with the aim of providing patients with more treatment options for diseases with high unmet needs,” UBE senior executive officer and general manager of the pharmaceutical division Yoichi Funayama said in the release.
Omlonti was evaluated in three randomized, controlled clinical trials of 3 months duration, according to the release. Reduction in IOP of 5 mm Hg to 7 mm Hg was observed in all three studies.
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