Safety and efficacy of topically administered netarsudil-latanoprost fixed dose combination (FDC; Rocklatan (TM)) in normal and glaucomatous dogs with ADAMTS10-open-angle glaucoma (ADAMTS10-OAG)

Objective The aim of the study was to evaluate safety and efficacy of topically administered 0.02% netarsudil-0.005% latanoprost fixed-dose combination (FDC) (Rocklatan (TM); Aerie Pharmaceutical) in normal and glaucomatous dogs with ADAMTS10-open-angle glaucoma (ADAMTS10-OAG). Animals studied Five normal and five glaucomatous beagle dogs with ADAMTS10-OAG were the study animals. Procedures In each dog, left (OS) or right eye (OD) was randomly selected for netarsudil-latanoprost FDC treatment. Contralateral eyes served as latanoprost-treated controls. The study was divided into four consecutive study periods: following a 4-day baseline period, two sequential 8-day study periods followed with once daily (q24h) and twice daily (q12h) treatments and ending with a washout period. Efficacy was measured by diurnal intraocular pressure (IOP) and pupil diameter. Safety was assessed by routine ophthalmic examination, gonioscopy, and pachymetry. Differences in least square means of quantitative outcome measures were compared between FDC and latanoprost treatments by using the linear Gaussian model. Results Baseline IOPs were 13.6 +/- 0.7 mmHg (mean +/- SEM) in normal and 28.3 +/- 1.4 mmHg in OAG-affected dogs. There was a significant decrease in mean diurnal IOP following FDC administration in both normal (q24h: -2.1 mmHg; q12h: -4.1 mmHg) and glaucomatous dogs (q24h: -14.2 mmHg; q12h: -17.7 mmHg; p < .0001). There was no significant difference in the treatment effect when comparing FDC to latanoprost. Both FDC and latanoprost administration resulted in similarly significant pupil constriction (p < .0001). The FDC administration was well-tolerated but resulted in conjunctival hyperemia. Conclusions Once or twice daily administration of netarsudil-latanoprost FDC (Rocklatan (TM)) and latanoprost was equally effective in lowering IOP in normal and OAG-affected dogs. There was no netarsudil-related added treatment effect.