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Purpose <p>To evaluate the long-term safety and intraocular pressure (IOP)-lowering efficacy of sepetaprost, a novel dual FP/EP3 receptor agonist, in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT).</p> Study design <p>ANGEL-J2 (NCT05503901) was a phase 3, randomised, parallel-group, open-label study across 20&#xa0;sites in Japan.</p> Methods <p>Adult patients with IOP ≥16 and &lt;22 mmHg were assigned to once-daily sepetaprost 0.002% (Group 1), whereas patients with IOP ≥22 and ≤34 mmHg were randomised 1:1 to once-daily sepetaprost 0.002% alone (Group 2) and with twice-daily timolol 0.5% (Group 3). Over 52 weeks of treatment, efficacy was assessed as the change in mean diurnal IOP from baseline; safety outcomes included the incidence of adverse drug reactions (ADRs).</p> Results <p>In total, 131 patients were assigned to Group 1 (n=49), Group 2 (n=42), or Group 3 (n=40). In each group, treatment was associated with rapid and sustained reductions in IOP versus baseline (<i>p</i>&lt;0.0001 at all time-points). Mean (± standard error) change in diurnal IOP from baseline at week 52 was −4.40±0.24, −6.38±0.32, and −7.51±0.29 mmHg in Groups 1, 2, and 3, respectively; similarly, mixed model for repeated measures analyses found that reductions in mean diurnal IOP over 52 weeks were greater in Group 3 versus Group 2. ADRs were reported in 80 patients overall (59.2–65.0% across groups), most commonly mild eyelash growth (22.4–42.5%) and mild conjunctival hyperaemia (28.6–30.6%).</p> Conclusion <p>Sepetaprost, with or without timolol, demonstrated good tolerability and may represent an efficacious long-term treatment option for OAG or OHT.</p>

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Long-term safety and efficacy of sepetaprost, with or without timolol, in patients with open-angle glaucoma or ocular hypertension: results from the randomised, phase 3 ANGEL-J2 study

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  • 发表日期：

    2026年6月16日

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  • Masaru Inatani,
  • Yuko Tone,
  • Toshihiro Ikeda,
  • Raymund Angeles

摘要

Purpose

To evaluate the long-term safety and intraocular pressure (IOP)-lowering efficacy of sepetaprost, a novel dual FP/EP3 receptor agonist, in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT).

Study design

ANGEL-J2 (NCT05503901) was a phase 3, randomised, parallel-group, open-label study across 20 sites in Japan.

Methods

Adult patients with IOP ≥16 and <22 mmHg were assigned to once-daily sepetaprost 0.002% (Group 1), whereas patients with IOP ≥22 and ≤34 mmHg were randomised 1:1 to once-daily sepetaprost 0.002% alone (Group 2) and with twice-daily timolol 0.5% (Group 3). Over 52 weeks of treatment, efficacy was assessed as the change in mean diurnal IOP from baseline; safety outcomes included the incidence of adverse drug reactions (ADRs).

Results

In total, 131 patients were assigned to Group 1 (n=49), Group 2 (n=42), or Group 3 (n=40). In each group, treatment was associated with rapid and sustained reductions in IOP versus baseline (p<0.0001 at all time-points). Mean (± standard error) change in diurnal IOP from baseline at week 52 was −4.40±0.24, −6.38±0.32, and −7.51±0.29 mmHg in Groups 1, 2, and 3, respectively; similarly, mixed model for repeated measures analyses found that reductions in mean diurnal IOP over 52 weeks were greater in Group 3 versus Group 2. ADRs were reported in 80 patients overall (59.2–65.0% across groups), most commonly mild eyelash growth (22.4–42.5%) and mild conjunctival hyperaemia (28.6–30.6%).

Conclusion

Sepetaprost, with or without timolol, demonstrated good tolerability and may represent an efficacious long-term treatment option for OAG or OHT.