Netarsudil/latanoprost ophthalmic solution 0.02%/0.005%
Our second product candidate for the reduction of intraocular pressure (IOP) in glaucoma and ocular hypertension (OHT) is Roclatan™ (netarsudil/latanoprost ophthalmic solution 0.02%/0.005%), an investigational product not approved by the Food and Drug Administration (FDA). It is being evaluated as a once-daily eye drop that combines netarsudil—the active ingredient in our approved product, Rhopressa® (netarsudil ophthalmic solution) 0.02%—with latanoprost, prostaglandin analog (PGA) that is the most commonly-prescribed medication for lowering IOP. If approved, this product would be the first fixed-dose combination (FDC) product containing a PGA in the United States. Results from two U.S. pivotal trials (Mercury 1 and Mercury 2) suggest the FDC of netarsudil and latanoprost has the potential to provide greater IOP-lowering than the most commonly prescribed glaucoma products. On the basis of these data, Aerie filed a New Drug Application (NDA) with the FDA for this product in May 2018. In July, the NDA was accepted and a Prescription Drug User Fee Act (PDUFA) action date of March 14, 2019 was set.
The Mercury program includes three Phase 3 clinical trials:
MERCURY 1 Trial
The first Phase 3 registration trial for Roclatan™ was a 12-month efficacy and safety trial, which had a successful 90-day efficacy readout in September 2016 demonstrating statistical superiority of the FDC to each of the individual components, with an IOP-lowering effect beyond the comparators in the range of 1 to 3 mmHg.ͣ
MERCURY 2 Trial
The second Phase 3 registration trial was Mercury 2, a 90-day efficacy and safety trial completed in May 2017. Roclatan™ lowered IOP by 1 to 3 mmHg beyond the comparators, thereby achieving its primary efficacy endpoint of statistical superiority to the comparators.
Adverse events, reported at an incidence of greater than or equal to 10% in pooled results of the Mercury 1 and Mercury 2 studies, included conjunctival hyperemia (59%), instillation site pain (20%), cornea verticillata (15%) and conjunctival hemorrhage (11%).
MERCURY 3 Trial
The third Phase 3 trial is Mercury 3, which commenced in Europe in the third quarter of 2017 and is ongoing. Mercury 3 is not necessary for approval in the U.S. This trial compares Roclatan™ to Ganfort®, a fixed-dose combination product of bimatoprost and timolol marketed in Europe. If successful, Mercury 3 is expected to facilitate regulatory approval and improve commercialization prospects in Europe.
Glaucoma is a chronic, progressive disease in which elevated intraocular pressure (IOP) is associated with damage to the optic nerve, resulting in irreversible vision loss and, potentially, blindness. There is no direct correlation between the extent of damage to the optic nerve and the level of IOP at diagnosis, which makes glaucoma a highly individualized disease. However, reduction of IOP has been shown to protect the optic nerve from further damage across all levels of baseline IOP and associated visual field loss making IOP the only modifiable risk factor for individualized care.
The National Eye Institute estimates that more than 2.7 million people in the United States suffer from glaucoma, a number expected to reach 4.3 million by 2030. Furthermore, The Eye Diseases Prevalence Research Group has estimated that only half of those with glaucoma in the US know they have the disease.1-2
1. National Institutes of Health. Glaucoma-Angle Glaucoma Defined Tables website. https://nei.nih.gov/eyedata/glaucoma/tables. Accessed November 13, 2017. 2. National Eye Institute. National Eye Health Education Program. https://nei.nih.gov/nehep/programs/glaucoma/learn-about. Accessed November 13, 2017.
ͣTopline Mercury 1 results were also included as supportive data in the Rhopressa® NDA.