Sepetaprost Effective and Safe in Glaucoma, Ocular Hypertension – Monthly Prescribing Reference

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.

Reference

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.

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Sepetaprost Effective and Safe in Glaucoma, Ocular Hypertension - Monthly Prescribing Reference