Aerie announced that the Food and Drug Administration (FDA) has approved Rhopressa (netarsudil ophthalmic solution) for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
Rhopressa, a rho kinase inhibitor, is believed to reduce intraocular pressure by increasing the outflow of aqueous humor through the trabecular meshwork route. The product was evaluated in 3 randomized and controlled clinical trials: Study 301, Study 302, and Study 304. Studies 301 and 302 evaluated patients with baseline intraocular pressure <27mmHg whereas Study 304 evaluated patients with baseline intraocular pressure <30mmHg.
Findings from the 3 studies showed up to a 5mmHg reduction in intraocular pressure for patients treated with Rhopressa 0.02% once daily in the evening. For patients with baseline intraocular pressure <25mmHg, the reductions were similar between the Rhopressa 0.02% and timolol 0.5% treatment groups. For patients with baseline intraocular pressure ≥25mmHg, the reductions at the morning time points were smaller in the Rhopressa group vs the timolol group for study visits on Days 43 and 90.
The most common adverse reactions associated with Rhopressa are conjunctival hyperemia, cornea verticillata, instillation site pain, and conjunctival hemorrhage.
Rhopressa 0.02% ophthalmic solution will be available as a 2.5mL fill in a 4mL container. It is anticipated to launch by the middle of the second quarter of 2018.
For more information call (908) 470-4320 or visit Rhopressa.com.