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Santen initiates phase 3 trials of omidenepag isopropyl for glaucoma, ocular hypertension
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A pivotal phase 3 development program of omidenepag isopropyl for the treatment of glaucoma or ocular hypertension has been initiated by Santen Inc., the company announced in a press release.
The SPECTRUM 3 and SPECTRUM 4 trials, both randomized, double-masked, active-controlled, parallel-group, multicenter studies, will assess the efficacy and safety of omidenepag isopropyl 0.002% ophthalmic solution (DE-117), a selective agonist for the prostanoid receptor EP2, in comparison to timolol maleate 0.5%.
“Currently when glaucoma treatments fail, patients urgently need therapeutic options with differentiated mechanisms of action to effectively reduce intraocular pressure,” Naveed Shams, MD, PhD, Santen’s chief scientific officer and head of global research and development, said in the release. “By increasing the aqueous humor outflow through both uveoscleral and trabecular pathways, omidenepag isopropyl has the potential to provide physicians with a novel option to treat elevated pressure in glaucoma.”
The primary objective of both the 12-month SPECTRUM 3 trial and 3-month SPECTRUM 4 trial is to demonstrate whether once-daily omidenepag isopropyl is non-inferior to twice-daily timolol in reducing IOP, the release said.