What question did this study set out to answer?

This research aims to assess the efficacy and safety of sepetaprost in lowering intraocular pressure among patients with primary open-angle glaucoma and ocular hypertension.

June 17, 2026Japanese Journal of Ophthalmology1 citationsOpen Access

Efficacy and safety of sepetaprost in patients with primary open-angle glaucoma or ocular hypertension: results from the randomised, phase 3 ANGEL-J1 study

MIMasaru InataniUniversity of Fukui AKAkiyasu KanamoriKobe University MIMaya InaiSanten (Japan)

Key Points

This research aims to assess the efficacy and safety of sepetaprost in lowering intraocular pressure among patients with primary open-angle glaucoma and ocular hypertension.
Randomized, phase 3, investigator-masked, active-controlled trial across 49 sites in Japan.
Patients with primary open-angle glaucoma or ocular hypertension were randomly assigned to receive either sepetaprost or latanoprost once daily for three months.
Primary endpoint: change in mean diurnal intraocular pressure from baseline at week 4.
Sepetaprost group exhibited a mean change in intraocular pressure of -5.77±0.16 mmHg, while latanoprost group showed -6.10±0.16 mmHg at week 4 (non-inferiority demonstrated).
Key secondary endpoint showed comparable IOP reductions between sepetaprost and latanoprost maintained over the three months.
Adverse drug reactions occurred in 36.4% of sepetaprost patients versus 20.2% of latanoprost patients, with conjunctival hyperaemia being the most common.

Abstract

Abstract Purpose To evaluate the efficacy and safety of sepetaprost, a novel dual FP/EP3 receptor agonist, in patients with primary open-angle glaucoma (POAG) or ocular hypertension (OHT). Study design ANGEL-J1 (NCT05495061) was a phase 3, randomised, investigator-masked, active-controlled, parallel-group, non-inferiority study across 49 sites in Japan. Methods Adults with POAG or OHT were randomised 1:1 to topical sepetaprost 0.002% or latanoprost 0.005%, once daily for 3 months. The primary endpoint was change in mean diurnal intraocular pressure (IOP) from baseline at week 4 (non-inferiority margin, 1.5 mmHg); a key secondary endpoint was mean change in IOP from baseline over 3 months. Safety outcomes included the incidence of adverse drug reactions (ADRs). Results In total, 325 patients were randomised to sepetaprost (n=162) or latanoprost (n=163). In mixed model for repeated measures analyses, ANGEL-J1 met its primary endpoint; the least-squares mean (± standard error) change in mean diurnal IOP from baseline at week 4 was −5.77±0.16 mmHg in the sepetaprost group, which was non-inferior to −6.10±0.16 mmHg in the latanoprost group (least-squares mean difference, 0.32 mmHg 95% confidence interval, −0.12, 0.77). Non-inferiority for the key secondary endpoint was also established, with comparable mean reductions in IOP between groups maintained over 3 months. ADRs occurred in 59 patients (36.4%) receiving sepetaprost and 33 (20.2%) receiving latanoprost; the most common ADR was conjunctival hyperaemia (29.6% and 8.6%, respectively; mostly mild in severity). Conclusion In patients with POAG or OHT, sepetaprost demonstrated IOP-lowering efficacy that was non-inferior to latanoprost, and an acceptable safety profile.

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