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Lourdes Rodriguez, Javier Fernando Casiraghi, Daniel Grigera, Alejo Peyret, Silvia Passerini; Efficacy and tolerability of a new thermostable formulation of latanoprost in nanoparticles. Invest. Ophthalmol. Vis. Sci. 2018;59(9):1236.
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© ARVO (1962-2015); The Authors (2016-present)
Benzalkonium chloride (BAK) has known toxic effects on the ocular surface on long-term use. A new latanoprost 0.005% BAK-free ophthalmic nanoemulsion (LNe) was developed to improve patient comfort and tolerability. It is stable at 30°C and 35% relative humidity for 24 months. We hypothesized that this innovative formulation has the same intraocular pressure (IOP)-lowering efficacy and is better tolerated than the BAK-containing latanoprost solution (LSc).
A prospective, open-label, single-arm, 12-week study was carried on. Patients over 18 years old with primary open-angle glaucoma under treatment with LSc for ≥ 6 months (baseline), switched to LNe once daily. As primary outcome, IOP-lowering efficacy was evaluated after 4, 8 and 12 weeks of treatment with LNe. Non inferiority was defined as a mean difference (95% CI) from baseline of <1.5 mm Hg at every timepoint after switching. As secondary outcome, ocular surface damage was determined using Ocular Surface Disease Index (OSDI) score, Schirmer I Test, Break-up time (BUT), conjunctival hyperemia and corneal staining at baseline and after 4, 8 and 12 weeks of treatment with LNe. Adverse events were reported. Two-tailed repeated measures ANOVA with Bonferroni correction was used, and significance was set at p < 0.05.
A total of 103 patients (198 eyes) concluded the study. Six patients discontinued because of ocular itching, increased tearing, blurred vision, strange body sensation, dry eye or allergic eye reactions. No serious treatment-related adverse effects were reported. No patient had IOP > 20 mm Hg. LNe was non-inferior in lowering IOP than LSc, as 95% CI of mean IOP at every timepoint after switch to LNe were within the 1.5 mm Hg non-inferiority margin from baseline IOP (13.13-16.13 mm Hg): 13.65-14.35, 13.38-14.07, 13.33-13.98 mm Hg (4, 8 and 12 weeks, respectively) (figure 1). After 12 weeks of treatment with LNe, all ocular surface parameters improved (table 1). Number of eyes with conjunctival hyperemia and corneal staining decreased 27.7% and 19.2%, respectively.
The new formulation of latanoprost in nanoemulsion showed the same IOP-lowering efficacy as the conventional formulation with significant improvements of ocular surface parameters, adding the advantage of being stored at room temperature.
This is an abstract that was submitted for the 2018 ARVO Annual Meeting, held in Honolulu, Hawaii, April 29 - May 3, 2018.
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