Roclatan Meets Primary Endpoint in Phase 3 Glaucoma Study
Aerie Pharmaceuticals announced promising primary efficacy results from the Phase 3 Mercury 2 study of Roclatan (netarsudil/latanoprost) ophthalmic solution 0.02%/0.005% for the treatment of glaucoma.
The evaluation of Roclatan has been ongoing in two distinct trials. In September 2016, Aerie reported topline efficacy findings from its first Phase 3 registration trial, Mercury 1. The results from Mercury 2 proved consistent with Mercury 1's 90-day efficacy results.
Mercury 2 compared the fixed-dose combination Roclatan to the prostaglandin analogue latanoprost and the Company's other candidate, Rhopressa (netarsudil) ophthalmic solution 0.02%. Results showed that Roclatan lowered intraocular pressure (IOP) by 1–3mmHg more than either latanoprost or Rhopressa 0.02% alone, demonstrating statistical superiority. In addition, Roclatan demonstrated benefit in reducing mean diurnal IOPs to 16mmHg or lower in 56% of its treatment group, achieving a higher percentage than either of its comparators.
In evaluating discontinuation rates, use of Roclatan resulted in lower rates than Rhopressa (9.8% vs. 10.6%). The most common adverse event associated with Roclatan was mild hyperemia, or eye redness (55%). There were no serious or systemic adverse reactions reported in any treatment group.
Roclatan is a combination product of netarsudil, a rho kinase (ROCK) and norepinephrine transporter (NET) inhibitor, and latanoprost, a prostaglandin analogue. Through both agents, Roclatan may act through all four mechanisms of lowering IOP, representing a novel approach to treatment of glaucoma and ocular hypertension.
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