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Introduction <p>Understanding the 24-h efficacy and safety of a novel therapy option, sepetaprost ophthalmic solution 0.002% vs. latanoprost ophthalmic solution 0.005%, may delineate its future position in glaucoma treatment.</p> Methods <p>In this exploratory study (EudraCT 2020-004836-93), adults with primary open-angle glaucoma (POAG) or ocular hypertension (OHT) were randomized to sepetaprost or latanoprost for 3&#xa0;months following a ≤ 35-day screening period. The primary endpoint was mean 24-h intraocular pressure (IOP) at month&#xa0;3 with sepetaprost vs. latanoprost. Safety outcomes included rate of adverse events (AEs).</p> Results <p>Overall, 33 participants received treatment (sepetaprost, <i>n</i> = 17; latanoprost, <i>n</i> = 16). Mean 24-h IOP was numerically lower with sepetaprost vs. latanoprost at month&#xa0;3 (− 0.88&#xa0;mmHg; 95% confidence interval [CI] − 2.89, 1.14; not statistically significant at the 0.05 level [NS]). Mean change from baseline in IOP at month&#xa0;3 ranged from − 5.63 to − 7.00&#xa0;mmHg for sepetaprost and − 3.84 to − 6.66&#xa0;mmHg for latanoprost. Lower nocturnal IOP was observed with sepetaprost vs. latanoprost at month&#xa0;3 (− 1.61&#xa0;mmHg difference; 95%&#xa0;CI − 4.05, 0.83; not statistically significant; however, the 90%&#xa0;CI was − 5.27, − 0.17 and therefore, nominal statistical significance was achieved at the 0.10 level). Mean difference between groups indicated similar, or numerically lower, IOP with sepetaprost at individual time points at week&#xa0;6 and month&#xa0;3. At 36 and 48&#xa0;h following sepetaprost cessation, mean IOP was lower vs. baseline IOP at the same time points. AEs occurred in 13 (76.5%) vs. 11 (68.8%) participants treated with sepetaprost vs. latanoprost.</p> Conclusion <p>In participants with POAG or OHT, mean 24-h IOP and nocturnal IOP at month&#xa0;3 were consistently numerically lower with sepetaprost vs. latanoprost. Safety profiles were similar between groups.</p> Trial Registration <p>EudraCT 2020-004836-93.</p>

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A Study of 24-h Efficacy and Safety of Sepetaprost vs. Latanoprost in Patients with Primary Open-Angle Glaucoma or Ocular Hypertension

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年6月10日

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  • Anastasios-Georgios Konstas,
  • Gerhard Garhöfer,
  • Jan Lübke,
  • Bogomil Voykov,
  • Auli Ropo

摘要

Introduction

Understanding the 24-h efficacy and safety of a novel therapy option, sepetaprost ophthalmic solution 0.002% vs. latanoprost ophthalmic solution 0.005%, may delineate its future position in glaucoma treatment.

Methods

In this exploratory study (EudraCT 2020-004836-93), adults with primary open-angle glaucoma (POAG) or ocular hypertension (OHT) were randomized to sepetaprost or latanoprost for 3 months following a ≤ 35-day screening period. The primary endpoint was mean 24-h intraocular pressure (IOP) at month 3 with sepetaprost vs. latanoprost. Safety outcomes included rate of adverse events (AEs).

Results

Overall, 33 participants received treatment (sepetaprost, n = 17; latanoprost, n = 16). Mean 24-h IOP was numerically lower with sepetaprost vs. latanoprost at month 3 (− 0.88 mmHg; 95% confidence interval [CI] − 2.89, 1.14; not statistically significant at the 0.05 level [NS]). Mean change from baseline in IOP at month 3 ranged from − 5.63 to − 7.00 mmHg for sepetaprost and − 3.84 to − 6.66 mmHg for latanoprost. Lower nocturnal IOP was observed with sepetaprost vs. latanoprost at month 3 (− 1.61 mmHg difference; 95% CI − 4.05, 0.83; not statistically significant; however, the 90% CI was − 5.27, − 0.17 and therefore, nominal statistical significance was achieved at the 0.10 level). Mean difference between groups indicated similar, or numerically lower, IOP with sepetaprost at individual time points at week 6 and month 3. At 36 and 48 h following sepetaprost cessation, mean IOP was lower vs. baseline IOP at the same time points. AEs occurred in 13 (76.5%) vs. 11 (68.8%) participants treated with sepetaprost vs. latanoprost.

Conclusion

In participants with POAG or OHT, mean 24-h IOP and nocturnal IOP at month 3 were consistently numerically lower with sepetaprost vs. latanoprost. Safety profiles were similar between groups.

Trial Registration

EudraCT 2020-004836-93.