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Efficacy and safety assessment of preservative‐free latanoprost (T2345) versus Xalatan™ in ocular hypertensive or glaucomatous patients
Author(s) -
ROULAND JF
Publication year - 2012
Publication title -
acta ophthalmologica
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.534
H-Index - 87
eISSN - 1755-3768
pISSN - 1755-375X
DOI - 10.1111/j.1755-3768.2012.f030.x
Subject(s) - latanoprost , medicine , ocular hypertension , intraocular pressure , glaucoma , ophthalmology , clinical endpoint , clinical trial
Purpose To assess the efficacy on intraocular pressure (IOP) and safety of preservative‐free latanoprost (T2345) versus BAK‐preserved latanoprost (Xalatan™) for the treatment of open‐angle glaucoma (POAG) and ocular hypertension (OHT), through 2 clinical trials (phase II and III). Methods A pilot phase II, cross‐over, 6‐week study with plasma samples was conducted in (2x15) patients. In an international investigator‐masked, phase III study, 402 patients with POAG or OHT already controlled by Xalatan™ were randomized to receive either T2345 or Xalatan™ for 3 months, after a 5‐week run‐in period with brinzolamide and a 5‐day wash‐out period so as to achieve an IOP ≥ 22 mmHg at baseline. The main primary endpoint was the change in IOP at 9:00 am between D0 and D84 in the worse eye. Safety parameters were also assessed. Results The mean IOP was reduced from baseline to D84 by 36% with T2345 (‐8.6 ± 2.6 mmHg) and 38% with Xalatan™ (‐9.0 ± 2.4 mmHg). These results met the limits set for non‐inferiority of T2345 to Xalatan™. Conjunctival hyperaemia was less frequent on T2345 at D42 and D84 (20% vs. 30% on Xalatan™). Upon instillation, the subjective ocular symptom score was lower on T2345 than on Xalatan™ (p=0.001). The phase II study showed comparable efficacy on IOP of both products during the whole day (8am, 12am, 4pm and 8pm). After instillation, AUC(0‐30) was 1086 ± 509 pg.min/mL on T2345 and 1379 ± 784 pg.min/mL on Xalatan™, suggestive of lower plasma concentrations of latanoprost on T2345 treatment (p=0.036). Conclusion T2345 is the first preservative‐free formulation of latanoprost, stable at room temperature, showing a non‐inferior IOP lowering efficacy compared to Xalatan™, with improved local tolerance.