Sepetaprost noninferior to timolol in lowering IOP
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CHICAGO — Once-daily sepetaprost was noninferior to twice-daily timolol in reducing IOP in patients with primary open-angle glaucoma or ocular hypertension, according to a study presented at the American Academy of Ophthalmology meeting.
David L. Wirta, MD, and colleagues wrote in a poster presentation that FP receptor agonists can be effective for managing elevated IOP, but not all patients respond to treatment.
“Sepetaprost is a novel investigational prodrug that targets two prostaglandin receptors, FP and EP3,” they wrote.
The randomized, double-masked, controlled phase 2 ANGEL-2 study evaluated sepetaprost (Santen) in 162 patients with primary open-angle glaucoma or ocular hypertension vs. timolol in 161 patients for 3 months. The primary efficacy endpoints were noninferiority of sepetaprost vs. timolol, consisting of a difference in mean IOP between the two drugs of no more than 1.5 mm Hg at nine specified time points (8 a.m., 10 a.m. and 4 p.m. at week 2, week 6 and month 3) and a difference of 1 mm Hg or less during at least five of the nine time points, and superiority of sepetaprost vs. timolol, consisting of no difference in IOP between the two drugs at all nine time points.
Wirta and colleagues observed an IOP reduction in the sepetaprost group by week 2, with stable IOP lowering throughout the study.
Sepetaprost was noninferior to timolol at all specified time points and superior to timolol at 4 p.m. at week 2, week 6 and month 3.
The rate of adverse events was 22.4% for all patients in the study, with all events mild or moderate in severity.
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Wirta DL, et al. Sepetaprost non-inferiority to timolol maleate in primary open-angle glaucoma or ocular hypertension: The ANGEL-2 study. Presented at: American Academy of Ophthalmology meeting; Sept. 30-Oct. 3, 2022; Chicago.
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