Latanoprost safe for children with glaucoma, ocular hypertension
The prostaglandin (PG) analogue latanoprost demonstrates an acceptable safety profile in the long-term treatment of paediatric patients with glaucoma and ocular hypertension, with no evidence of clinically meaningful changes in ocular development or hyperpigmentation, according to the results of a 3-year safety study of the drug.
A total of 175 paediatric patients, among whom 102 (median age 9 years) were on latanoprost and 73 (median age 5 years) were receiving non-PG treatment, were included in the study. Of these, 148 (84.6 percent) completed the 3-year follow up, 88 (86.3 percent) and 60 (82.2 percent) in the latanoprost and non-PG groups, respectively. The average follow up was 36 months.
The primary endpoint of mean change in best corrected visual acuity (BCVA) from baseline at 3 years did not significantly differ between the two groups (latanoprost: 0.01 LogMar; 95 percent CI, –0.04 to 0.06; non-PG: 0.04 LogMar; –0.03 to 0.11). Mean difference was –0.03 LogMar units equivalent to <1 Snellen line of vision. [Am J Ophthalmol 2018;doi:10.1016/j.ajo.2018.08.039]
Furthermore, no significant changes from baseline were observed in the secondary endpoints of horizontal corneal diameter, eyelash length, intraocular pressure (IOP) and corneal thickness in the two groups.
“Treatment-emergent adverse events (TEAEs) were mostly mild and occurred in a small proportion of participants in both treatment groups,” the authors noted.
However, more patients in the latanoprost group developed TEAEs compared with those in the non-PG group. There were no reports of cystoid macular oedema in the subgroup of patients who had developed glaucoma following cataract surgery (GFCS). No deaths occurred.
“In this real-world long-term study of paediatric patients, latanoprost showed an acceptable safety profile for the treatment of glaucoma and elevated IOP,” the authors said.
However, despite including a large and generalizable cohort of paediatric glaucoma patients and prospective data collection, the present study must be interpreted in light of several limitations, they continued.
“This was a noninterventional study, and all participants were treated according to standard medical practice across the enrolling geographical sites, and the treating physicians could modify the IOP-lowering therapy with other medications and surgery as clinically indicated and according to their personal preferences,” they pointed out.
Moreover, evaluations were limited to the effects of only latanoprost and latanoprost–timolol combination on the paediatric eye. Therefore, the results may not be generalizable to other commercially available PGs.
“Optimal management of childhood glaucoma depends upon a number of factors, including the type and severity of the glaucoma, as well as the child’s age and comorbidities (both ocular and systemic). For most cases of primary congenital glaucoma, surgery is the initial treatment, with medications playing an adjunctive role before and, sometimes, after surgery when the glaucoma is not completely controlled,” the authors said.
“In contrast, pharmacologic therapy is usually appropriate as initial management for most cases of juvenile open-angle glaucoma. Regardless of the type of the glaucoma, IOP reduction is the highest priority for halting or slowing the progression of this life-long disease,” they added.