This article is part of MPR’s coverage of the American Academy of Ophthalmology 2019 Meeting, taking place in San Francisco, CA. Our staff will report on medical research related to eye disorders, conducted by experts in the field. Check back regularly for more news from AAO 2019.
SAN FRANCISCO – Sepetaprost 0.002% was found to be safe, effective, and comparable to latanoprost in patients with primary open-angle glaucoma or ocular hypertension, according to a study presented at the American Academy of Ophthalmology (AAO) 2019 Annual Meeting, held October 12-15, 2019 in San Francisco, California.
The randomized, multicenter, placebo- and active-controlled, parallel-group, phase 2b ANGEL trial evaluated the efficacy and safety of sepetaprost compared to latanoprost in patients with primary open-angle glaucoma or ocular hypertension for 3 months. After washout, patients were randomized 2:2:2:2:2:1 at baseline to receive sepetaprost (0.0005%, 0.001%, 0.002%, 0.003%) once daily, latanoprost 0.005% once daily or placebo followed by sepetaprost 0.003% at week 6. Intraocular pressure (IOP) was measured at 3 different times (9 AM, 1 PM, 5 PM) during the day, over 6 total visits during a 3-month period. The primary end point was IOP in the study eye at 3 different time-points throughout the day at Month 3; key secondary end points included IOP in the study eye at Week 6 and mean diurnal IOP at Weeks 1, 2, 6, and Month 3.
Results showed similar reductions in IOP between sepetaprost 0.002% and latanoprost at all timepoints, along with similar mean diurnal IOP change from baseline at Month 3 of -6.9mmHg and -6.7mmHg, respectively. Compared to placebo, all doses of sepetaprost significantly reduced IOP from baseline at Week 6 (P<.0001). The study found 0.002% to be the optimal dose, outperforming the 0.003% dose, however, a positive dose-response relationship was seen with the lower doses.
With regard to safety, patients treated with sepetaprost 0.002% experienced a lower incidence of adverse events than with latanoprost (34.1% vs 50.0%, respectively). The most common treatment-emergent adverse event was conjunctival hyperemia for both sepetaprost 0.002% (20.5%) and latanoprost (27.3%).
Sepetaprost (DE-126) is a novel prostaglandin ophthalmic product with a dual agonistic activity on both FP and EP3 receptors.
Wirta DL, et al. Dose-Finding Study of Sepetaprost Ophthalmic Solution in Patients With POAG or OHT: The Phase 2b ANGEL Study. Presented at: The American Academy of Ophthalmology (AAO) 2019 Annual Meeting; October 12-15, 2019; San Francisco, California. Poster number: PO174.