• SKIP TO CONTENT
  • SKIP NAVIGATION
  • Patient Resources
    • COVID-19 Patient Resource Center
    • Clinical Trial Listings
    • What is Clinical Research?
    • Volunteering for a Clinical Trial
    • Understanding Informed Consent
    • Useful Resources
    • FDA Approved Drugs
  • Professional Resources
    • Research Center Profiles
    • Market Research
    • FDA Approved Drugs
    • Training Guides
    • Books
    • eLearning
    • Events
    • Newsletters
    • White Papers
    • SOPs
    • eCFR and Guidances
  • White Papers
  • Clinical Trial Listings
  • Advertise
  • COVID-19
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Directories » FDA Approved Drugs » Rocklatan (netarsudil and latanoprost ophthalmic solution)

AND
  • A
  • B
  • C
  • D
  • E
  • F
  • G
  • H
  • I
  • J
  • K
  • L
  • M
  • N
  • O
  • P
  • Q
  • R
  • S
  • T
  • U
  • V
  • W
  • X
  • Y
  • Z

Rocklatan (netarsudil and latanoprost ophthalmic solution)

  • Profile

Profile

Contact Information

Contact: Aerie Pharmaceuticals
Website: https://rocklatan.com/

Currently Enrolling Trials

    Show More

    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.

    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.

    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

    Clinical Trial Results

    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.

    Approval Date: 2019-03-01
    Company Name: Aerie Pharmaceuticals
    Back to Listings

    Upcoming Events

    • 25Apr

      Effective Root Cause Analysis and CAPA Investigations for Drugs, Devices and Clinical Trials

    • 26Apr

      FDA’s New Laws and Regulations: What Drug and Biologics Manufacturers Need to Know

    • 27Apr

      Califf’s FDA, 2023 and Beyond: Key Developments, Insights and Analysis

    • 17May

      2023 WCG Avoca Quality Consortium Summit

    • 21May

      WCG MAGI Clinical Research Conference – 2023 East

    Featured Products

    • Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

      Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

    • Surviving an FDA GCP Inspection

      Surviving an FDA GCP Inspection: Resources for Investigators, Sponsors, CROs and IRBs

    Featured Stories

    • Five Ws

      Consider the Five ‘W’s to Understand Potential Participants

    • QandA-360x240.png

      Perspectives from Smaller-Sized CROs: Q&A with Cheryle Evans

    • White House

      Trial Stakeholders Advise White House on Emergency Research Infrastructure

    • SurveywBlueBackground-360x240.png

      Stress Levels Continue to Climb in Healthcare Workforce, Survey Finds

    Standard Operating Procedures for Risk-Based Monitoring of Clinical Trials

    The information you need to adapt your monitoring plan to changing times.

    Learn More Here
    • About Us
    • Contact Us
    • Privacy Policy
    • Do Not Sell or Share My Data

    Footer Logo

    300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

    Phone 617.948.5100 – Toll free 866.219.3440

    Copyright © 2023. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing