Noninferiority trials confirm IOP benefits of once-daily latanoprostene bunod

This pooled analysis assessed the efficacy and safety of latanoprostene bunod compared with timolol for the treatment of open-angle glaucoma.

Study design

The authors analyzed data from two phase 3, randomized, multicenter, double-masked, parallel-group, noninferiority trials (APOLLO and LUNAR), comprising 840 participants. Adults with open-angle glaucoma or ocular hypertension were randomized 2:1 to receive once-daily latanoprostene bunod (0.024%) or twice-daily timolol (0.5%) for 3 months.

Outcomes

Patients on latanoprostene bunod achieved a significantly lower mean IOP compared with timolol patients at 9 evaluation time points throughout 3 months of follow-up. The latanoprostene arm also had a greater number of subjects that attained a mean IOP of ≤18 mm Hg and an IOP reduction of ≥25% from baseline.

The study detected a 5.9% rate of conjunctival hyperemia in the latanoprostene bunod group. Eye irritation and pain occurred in less than 5% of patients. There were no serious safety concerns.

Limitations

The results might have been more clinically applicable if latanoprostene bunod had been compared with a prostaglandin analogue rather than timolol.

Clinical significance

This robust study confirms the efficacy of this novel ocular hypotensive agent, which was approved by the FDA in November 2017. Prior studies suggest that the agent may be more efficacious than prostaglandin analogues, which are currently considered first-line therapies. Further head-to-head trials comparing latanoprostene bunod with a prostaglandin therapy would help to elucidate which drug should be used as a first-line treatment.