Category: Clinical

Month: 16 Sep 2016

Issue: not yet available

Phase III data for 0.02%/0.005% netarsudil/latanoprost shows topline efficacy for lowering IOP in treatment of glaucoma.

Top-line efficacy data for the use of 0.02%/0.005% netarsudil/latanoprost (known as Roclatan) in lowering IOP has shown that the formulation achieved a primary efficacy endpoint of statistical superiority over each of its components alone. However, it remains unclear what proportion of patients obtained a clinically significant effect from the treatment. The Phase III study, named Mercury I, evaluated patients with a maximum baseline IOP between 20 and 36 mmHg and showed an IOP-lowering effect ranging between 1 and 3 mmHg beyond that of monotherapy with either latanoprost or netarsudil.

 

Data from the study, sponsored by a clinical stage US based company, Aerie Pharmaceuticals, will support submission of an NDA for the treatment of glaucoma. The NDA will additionally rely on data from two Phase 3 trials (“Rocket 1” and “Rocket 2”) for 0.02% netarsudil ophthalmic solution (known as Rhopressa). The sponsor reported that Rocket 2 represents the pivotal trial, and Rocket 1 is a supportive study while two additional Phase 3 trials underway for 0.02% netarsudil (named “Rocket 3” and “Rocket 4”) are safety-only studies (in Canada) and a further six-month safety study for regulatory requirements in Europe. If approved, the new formulation will be marketed as a once-daily eye drop that combines 0.02% netarsudil with latanprost, already widely prescribed globally for the treatment of glaucoma. Subject to FDA assessment, the sponsoir hopes to be market the treatment as an opportunity to come at glaucoma from several angles, including increasing the fluid outflow through the trabecular meshwork, increasing fluid outflow through the uveoscleral pathway, reducing fluid production in the eye, and reducing episcleral venous pressure (EVP). Hitting all IOP lowering mechanisms at once may potentially provide improved outcomes for glaucoma patients.

 

The supporting Phase 3 study (Mercury I) was a 12-month safety trial in 718 patients with a 90-day efficacy readout. A second Phase 3 study (Mercury 2) is understood to be a 90-day efficacy trial that commenced in March 2016, while a third Phase 3 study (Mercury 3) is scheduled to commence in EU sites at some stage in the first half of 2017. Commenting on the milestone, Vicente Anido, Jr., Ph.D., Chairman and Chief Executive Officer at Aerie stated, “we are very pleased by these RoclatanTM 90-day efficacy results from the Mercury 1 clinical trial. As expected, the topline efficacy demonstrated in this trial clearly reconfirms the potential for RoclatanTM to become the most efficacious IOP-lowering therapy to enter the market, if approved. If Mercury 1 and 2 are successful, we expect to file the NDA for RoclatanTM near year-end 2017.”

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