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Nnenna Ihekoromadu, Fenghe Lu, Ryo Iwamura, Kenji Yoneda, Noriko Kawabata-Odani, Naveed Kamal Shams; Safety and Efficacy of DE-117, a Selective EP2 Agonist in a Phase 2a Study. Invest. Ophthalmol. Vis. Sci. 2015;56(7 ):5708.
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To investigate the safety, efficacy and dose response of 4 concentrations of DE-117 ophthalmic solution (0.0003%, 0.001%, 0.002% and 0.003%) compared to Latanoprost (0.005%, LAT) and placebo (PBO) in patients with primary open-angle glaucoma (POAG) or ocular hypertension (OHT)
This was a randomized, observer-masked, placebo-and-active-controlled, parallel-group, multi-center study in 91 patients. After a washout period of up to 28 days, a baseline intraocular pressure (IOP) of 22-35 mmHg at 08:00 and at each additional time point was required. The eye with the higher diurnal IOP at baseline was the study eye. Both eyes were treated once daily at 20:00 for 4 weeks. Safety was assessed by adverse events (AEs) reported. Efficacy was assessed by changes in IOP from baseline. IOP was measured at 8:00, 10:00, 12:00 and 16:00 at baseline and weeks 1, 2 and 4 visits.
All doses of DE-117 were well-tolerated. The AEs of conjunctival hyperaemia, ocular hyperaemia, photophobia and eye pain were reported in the DE-117 groups (0.001%, 0.002% or 0.003%), however they were all mild and transient (Table 1).<br /> DE-117 0.002% showed numerically greater IOP reduction than LAT at Week 1 and similar IOP reduction compared to LAT through Week 4. DE-117 0.002% outperformed the rest of DE-117 groups in IOP reduction. (Figure 1). The lower DE-117 doses demonstrated a typical increasing dose response relationship, while the highest dose (0.003% DE-117) was not as effective as the 0.002% dose.
DE-117 was safe and well tolerated in patients with POAG and OHT. A U-shaped dose relationship was observed. The 0.003% dose was less effective than the 0.002% DE-117 dose. The 0.002% dose had numerically greater IOP reduction from baseline compared to LAT at Week 1, but similar efficacy to LAT through Week 4.
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