Key result
Sepetaprost 0.002% matches latanoprost for intraocular pressure lowering at 3 months.
Why the study?
The optimal dose of sepetaprost ophthalmic solution for lowering intraocular pressure in patients with primary open-angle glaucoma or ocular hypertension was not established.
RCT (n=241)
Observer-masked
Central randomization schedule using Interactive Response Technology
Yes
Sepetaprost 0.002% may serve as an alternative to latanoprost for IOP control; confirms comparable efficacy in this RCT.
Purpose: This phase 2b, randomized, observer-masked, placebo- and active-controlled, parallel-group, multinational (USA and Japan), multicenter study (NCT03216902) assessed the optimal dose of sepetaprost ophthalmic solution in patients with primary open-angle glaucoma or ocular hypertension. Methods: After washout, patients ≥18 years (USA) or ≥20 years of age (Japan) received once-daily sepetaprost for 3 months [0.0005% ( n = 43); 0.001% ( n = 43); 0.002% ( n = 44); and 0.003% ( n = 45)], latanoprost 0.005% ( n = 44) or placebo until week 6, followed by sepetaprost 0.003% until month 3 ( n = 22). Safety assessments included adverse event (AE) occurrence. Results: Baseline mean diurnal intraocular pressure (IOP) was 24.3 mmHg for latanoprost and ranged between 24.1 and 24.5 mmHg for the sepetaprost groups. Sepetaprost 0.002% had the lowest IOP at each month 3 time point (9:00 AM; 1:00 PM; 5:00 PM) of all sepetaprost concentrations (mean ± standard error: 17.6 ± 0.5; 17.4 ± 0.4; 16.7 ± 0.4 mmHg); similar values were observed with latanoprost (18.1 ± 0.6; 17.3 ± 0.5; 17.2 ± 0.5 mmHg). A positive dose–response relationship was observed with the 3 lower sepetaprost doses; sepetaprost 0.002% had numerically greater IOP-lowering effects than sepetaprost 0.003%. All sepetaprost doses had statistically significantly greater IOP reductions from baseline versus placebo at week 6 ( P < 0.0001). This IOP-lowering effect was consistent between Japan- and USA-based patients. Most AEs were mild and occurred numerically less frequently with sepetaprost 0.002% (34.1%) versus latanoprost (50.0%). The most frequently reported AE was conjunctival hyperemia. Conclusion: In this study, sepetaprost 0.002% was the optimal concentration, showing comparable IOP-lowering efficacy and safety with latanoprost 0.005%. Most AEs were mild; occurrence was numerically lower with sepetaprost 0.002% than latanoprost 0.005%.
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Wirta et al. (2022) conducted an RCT in Primary open-angle glaucoma or ocular hypertension (n=241). Sepetaprost vs. Latanoprost 0.005% or Placebo was evaluated on Intraocular pressure (IOP) at each time point (9:00 AM, 1:00 PM, and 5:00 PM) at month 3. Sepetaprost 0.002% was identified as the optimal concentration, achieving mean intraocular pressures of 16.7 to 17.6 mmHg across month 3 diurnal time points, demonstrating comparable efficacy to latanoprost 0.005% (17.2 to 18.1 mmHg).
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