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Kirsten Fischer, Jeffery J Prusakiewicz, Craig B Struble, Frank Loescher, Sonja Kroesser; The pharmacodynamic effect of LatanoSol® eye drops on IOP of normotensive dogs. Invest. Ophthalmol. Vis. Sci. 2018;59(9):2716. doi: https://doi.org/.
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© ARVO (1962-2015); The Authors (2016-present)
LatanoSol® is a novel water- and preservative free formulation based on the proprietary EyeSol®-Technology of Novaliq containing the prostaglandin analogue Latanoprost as active ingredient. LatanoSol® is expected to lower the intraocular pressure (IOP) by increasing the aqueous humor outflow, primarily through the uveoscleral pathway as reported for latanoprost containing formulations. As LatanoSol® has a considerably smaller droplet size, the tolerability and efficacy of different concentrations were investigated, also in comparison to the marketed product Xalatan™.
The pharmacodynamic effect on IOP was assessed following different doses of LatanoSol® or vehicle or Xalatan™ in conscious normotensive dogs in a blinded fashion. Animals (n = 8) were administered with a topical ocular dose once daily for seven days to each eye, followed by a washout period. IOP measurements and ocular irritation scoring were performed during each phase. Pharmacodynamic parameters including maximal effect (Emax) and area under the effect curve (AUCE) were calculated from the mean values.
A dose-dependent increase in efficacy was observed with increasing latanoprost concentrations in the EyeSol® vehicle at a dose range from 0.00125% to 0.005%. No obvious gain in efficacy was observed with a further increase of the dosage and overall comparable efficacy was observed for the latanoprost concentrations ranging from 0.005%, 0.01%, and 0.015% in EyeSol® vehicle. In a head to head comparison of LatanoSol® (11 µL OD, 1.1 µg/eye) and Xalatan™ (30 µL OS, 1.5 µg/eye), the mean Emax and AUCE values were comparable between the two formulations albeit the LatanoSol® formulation was at a lower dose level of latanoprost due to the smaller drop size. The mean Emax value were for LatanoSol® ( -35.3 ± 4.48%) and for Xalatan™ (-39.7 ± 3.76%). The corresponding AUCE values were -2360 ± 360 and -2860 ± 498% hour for LatanoSol® and Xalatan™, respectively. Ocular irritation scoring revealed no test article-related findings for the LatanoSol® formulations at all tested dose levels.
Repeated dosing with LatanoSol® eye drops resulted in a considerable IOP-lowering effect even in normotensive dogs. The animals showed no signs of toxicity and LatanoSol® was well tolerated. A comparable effect to Xalatan™ was reached even with a smaller droplet size and a lower targeted dose level.
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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