Bioequivalence of Preservative-Free and Preserved Omidenepag Isopropyl 0.002% Ophthalmic Solutions in Patients With Primary Open Angle Glaucoma or Ocular Hypertension: Phase 3 DAISY Study.

PRÉCIS: Preservative-free omidenepag isopropyl (OMDI) 0.002% ophthalmic solution and OMDI 0.002% ophthalmic solution preserved with benzalkonium chloride (BAK) were bioequivalent in lowering intraocular pressure (IOP) after 4 weeks' treatment in patients with primary open angle glaucoma (POAG) or ocular hypertension (OHT).

OBJECTIVE

Preservatives in ophthalmic solutions for lowering IOP are associated with ocular surface disease. The DAISY study evaluated the bioequivalence of preservative-free OMDI 0.002% ophthalmic solution (DE-117B), with OMDI 0.002% preserved with BAK.

METHODS

DAISY was a phase 3, randomized, evaluator-masked, crossover study conducted in Japan. Patients with POAG or OHT were randomized 1:1 to DE-117B or OMDI 0.002% for 4 weeks (period 1) and then crossed over for 4 weeks (period 2). A 4-week washout preceded both periods. The primary efficacy endpoint was mean diurnal (MD) IOP at week 4 (combined periods 1 and 2). Bioequivalence between DE-117B and OMDI was defined as a 95% CI between -1.5 and 1.5 for least squares mean between-group difference in MD IOP. Adverse events were monitored.

RESULTS

Of 74 patients enrolled, 38 were randomized to DE-117B, then OMDI, and 36 were randomized to OMDI then DE-117B. DE-117B and OMDI demonstrated bioequivalence at week 4 [MD IOP ± SD in summary statistics: 17.76 ± 2.05 mm Hg (DE-117B) vs 17.71 ± 2.01 mm Hg (OMDI); least squares mean ± SE between-group difference in linear mixed effect model: -0.02 ± 0.18 mm Hg (95% CI: -0.38 to 0.35)]. DE-117B versus OMDI was associated with numerically lower overall ocular discomfort.

CONCLUSIONS

Preservative-free DE-117B and BAK-containing OMDI were bioequivalent in lowering IOP after 4 weeks' treatment in Japanese patients with POAG or OHT. DE-117B was well tolerated with a similar safety profile to OMDI.