Rocklatan (netarsudil and latanoprost ophthalmic solution)

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

Approval Status:

Approved March 2019

Specific Treatments:

elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension

Therapeutic Areas

General Information

Rocklatan is a fixed-dose combination of latanoprost, a prostaglandin analog (PGA), and netarsudil, a first-in-class Rho kinase (ROCK) inhibitor. 

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

Rocklatan is supplied as a solution for topical 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. The dosage of Rocklatan should not exceed once daily. Rocklatan may be used concomitantly with other topical ophthalmic drug products to lower IOP. If more than one topical ophthalmic drug is being used, the drugs should be administered at least five (5) minutes apart.

Clinical Results

FDA Approval

The FDA approval of Rocklatan was based on two Phase III registration trials, MERCURY 1 and MERCURY 2.  Studies 301 and 302 enrolled subjects with IOP < 36 mmHg and compared IOP lowering effect of Rocklatan dosed once daily to individually administered netarsudil 0.02% once daily and latanoprost 0.005% once daily. The treatment duration was 12 months for MERCURY 1 and 3 months for MERCURY 2. In these studies, Rocklatan achieved its primary 90-day efficacy endpoint as well as positive 12-month safety and efficacy results, demonstrating statistically superior IOP reduction over latanoprost and netarsudil at every measured time point. More than 60% of patients taking Rocklatan in the two MERCURY studies achieved an IOP reduction of 30% or more; nearly twice that achieved by patients taking latanoprost alone. Rocklatan also helped more patients get to low target pressures. Nearly twice as many patients taking Rocklatan reached 16 mmHg or lower and nearly three times as many reached 14 mmHg or lower compared to latanoprost.

Side Effects

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

conjunctival hyperemia

instillation site pain

corneal verticillata

conjunctival hemorrhage

Mechanism of Action

Rocklatan is a fixed-dose combination of latanoprost (0.05 mg/mL (0.005%), a prostaglandin analog (PGA), and netarsudil (0.2 mg/mL (0.02%), a first-in-class Rho kinase (ROCK) inhibitor. It is specifically designed to target the trabecular meshwork (the eye’s principal drainage pathway). The diseased trabecular meshwork is considered to be the main cause of elevated IOP in open-angle glaucoma and ocular hypertension.

Additional Information

For additional information regarding Rocklatan or elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension, please visit http://investors.aeriepharma.com/