Article

Santen Begins Phase 3 Trials for Glaucoma Agonist

■ Santen Inc., a global company focused exclusively on ophthalmology, has initiated a pivotal phase 3 clinical program called SPECTRUM in the United States, evaluating the investigational use of omidenepag isopropyl, a selective agonist for the prostanoid receptor EP2, for the treatment of glaucoma or ocular hypertension (OHT).

The SPECTRUM clinical trial program includes 2 pivotal, phase 3, 430-patient, randomized, double-masked, active-controlled, parallel-group, multicenter trials assessing the efficacy and safety of omidenepag isopropyl 0.002% ophthalmic solution compared with timolol maleate 0.5% ophthalmic solution in patients with glaucoma or OHT. The trials include both adult (n=400) and pediatric (n=30) participants.