Rhopressa (netarsudil ophthalmic solution)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Approval Status:

Approved December 2017

Specific Treatments:

glaucoma or ocular hypertension

Therapeutic Areas

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General Information

Rhopressa (netarsudil ophthalmic solution) is a Rho kinase inhibitor.

Rhopressa is specifically indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.

Rhopressa is supplied as a solution for ophthalmic administration. The recommended dosage is one drop in the affected eye(s) once daily in the evening. If one dose is missed, treatment should continue with the next dose in the evening. Twice a day dosing is not well tolerated and is not recommended. If Rhopressa is to be used concomitantly with other topical ophthalmic drug products to lower IOP, administer each drug product at least 5 minutes apart.

Clinical Results

FDA Approval

The FDA approval of Rhopressa was based three phase III trial, ROCKET 1, ROCKET 2 and ROCKET 4. 

ROCKET-1. The trial did not meet its primary efficacy endpoint of demonstrating non-inferiority of IOP lowering for once-daily Rhopressa compared to twice-daily timolol. Rhopressa did demonstrate non-inferiority compared to timolol for patients in the study with IOP below 26 millimeters of mercury (mmHg) at all nine measured time points and numerical superiority over timolol at the majority of measured time points.

ROCKET-2. Rhopressa dosed both once-daily and twice-daily, achieved its primary efficacy endpoint demonstrating non-inferiority compared to twice-daily timolol. The primary efficacy endpoint evaluated subjects with pre-study baseline IOPs of above 20 to below 25 mmHg (millimeters of mercury). Data demonstrated a consistent level of IOP lowering across all baseline IOPs and throughout the 90-day efficacy period. The most common adverse event was adverse event was hyperemia, which was reported as increased in 35 percent of patients and was scored as mild for 83 percent of patients in the Rhopressa once-daily arm of the trial.

ROCKET-4. The study achieved its primary efficacy endpoint demonstrating non-inferiority of once-daily Rhopressa compared to twice-daily timolol. Rhopressa also demonstrated non-inferiority compared to timolol at the pre-specified secondary endpoint range of above 20 mmHg to below 27 mmHg, and also at a range of above 20 mmHg to below 28 mmHg. The efficacy results demonstrated a consistent level of IOP lowering across all baseline IOPs in the trial, and throughout the 90-day efficacy period.

Side Effects

Adverse effects associated with the use of Rhopressa may include, but are not limited to, the following:

  • conjunctival hyperemia
  • corneal verticillata
  • instillation site pain
  • conjunctival hemorrhage

Mechanism of Action

Rhopressa (netarsudil ophthalmic solution) is a Rho kinase inhibitor, which is believed to reduce IOP by increasing the outflow of aqueous humor through the trabecular meshwork route. The exact mechanism is unknown. 

Additional Information

For additional information regarding Rhopressa or glaucoma or ocular hypertension, please visit http://rhopressa.com/