Santen announced the initiation of the pivotal Phase 3 development program (SPECTRUM) in the United States, evaluating the investigational use of omidenepag isopropyl (DE-117), a selective agonist for the prostanoid receptor EP2, for the treatment of glaucoma or ocular hypertension (OHT).
The SPECTRUM program includes two pivotal, Phase 3, 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.
SPECTRUM 3 (NCT03691649) and SPECTRUM 4 (NCT03691662) will each enroll approximately 400 adult patients and up to 30 pediatric patients diagnosed with glaucoma or OHT across 70 clinical sites in the United States. Patients who meet eligibility criteria are randomized in a 1:1 ratio to receive either omidenepag isopropyl once-daily or timolol twice-daily. SPECTRUM 3 is a twelve months trial, consisting of a three-month double-masked treatment period and a nine-month open-label period, while SPECTRUM 4 spans over a total of three months. The primary objective of both studies is to demonstrate whether once-daily omidenepag isopropyl is non-inferior to twice-daily timolol in reducing intraocular pressure (IOP) after three months.
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"Santen's deep commitment to glaucoma drives us to advance therapeutic innovation in areas of unmet needs," said Naveed Shams, MD, PhD, Chief Scientific Officer and Head of Global Research and Development at Santen. "Currently when glaucoma treatments fail, patients urgently need therapeutic options with differentiated mechanisms of action to effectively reduce intraocular pressure. 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 initiation of the U.S. Phase 3 SPECTRUM program follows positive Phase 1/2, 2 and 2b dosing studies demonstrating that omidenepag isopropyl 0.002% is the most appropriate dose and performed similarly to latanoprost in IOP reduction. Omidenepag isopropyl was generally safe and well tolerated. Common side effects of FP agonists – such as iris and eyelid pigmentation, abnormal eyelash changes and deepening of upper eyelid sulcus – were not observed during long-term (12 months) use in a study conducted in Japan.
In September 2018, Santen announced receipt of manufacturing and marketing approval for glaucoma and ocular hypertension treatment omidenepag isopropyl (DE-117) 0.002% ophthalmic solution in Japan under the name EYBELIS.3 DE-117 is in global development and is also currently in a Phase 3 trial in Asia (beyond Japan).