Netarsudil/Latanoprost Fixed-Dose Combination for Elevated Intraocular Pressure: Three-Month Data from a Randomized Phase 3 Trial
| Autor: | Yao Liu, Brennan Greene, Jacob W. Brubaker, Kevin Y. Jong, Scott Corin, Justus W. Thomas, Vickas Khemsara, Ehsan Sadri, Thomas D. LoBue, William J. Flynn, Navin H Tekwani, William C. Christie, Farrell C. Tyson, Matthew J. Swanic, Damien F. Goldberg, Sanjay Asrani, Ranjan P. Malhotra, Matthew G. McMenemy, Karen L. Klugo, Lawrence B. Katzen, John F. Kozlovsky, Bernard R. Perez, Alan L. Robin, Stephen Vold, John Nicolau, Mihir Parikh, Dale W Usner, Ettaleah C. Bluestein, John S. Cohen, Stacey L. Ackerman, Thomas T. Henderson, Kundandeep Nagi, Nicole M. Collins, Jodi Ian Luchs, Robert M. Saltzmann, Andrew Mays, Jay Mulaney, Jody R. Piltz-Seymour, Sayoko E. Moroi, Fiaz Zaman, Savak Teymoorian, Eran Duzman, Howard I. Schenker, Casey Kopczynski, Gary Jerkins, Eugene B. McLaurin, Mark J. Weiss, Kent Bashford, Todd Daynes, Joseph P. Gira, Brian E. Flowers, Theresa Heah, Scott B. Han, Donna Leonardo, Michael Depenbusch, Janet B. Serle, Raymond Fong, James D. Boyce, James D. Branch, Louis M. Alpern, Lee S. Peplinski, Jay R. Patel, El-Roy Dixon, Richard A Lewis, Satish Modi |
|---|---|
| Rok vydání: | 2019 |
| Předmět: |
Male
medicine.medical_specialty Intraocular pressure genetic structures Fixed-dose combination Glaucoma Ocular hypertension Phases of clinical research Administration Ophthalmic Benzoates law.invention 03 medical and health sciences chemistry.chemical_compound Tonometry Ocular 0302 clinical medicine Randomized controlled trial Double-Blind Method law Ophthalmology medicine Clinical endpoint Humans Latanoprost Antihypertensive Agents Intraocular Pressure 030304 developmental biology Aged 0303 health sciences rho-Associated Kinases business.industry Middle Aged medicine.disease eye diseases Drug Combinations chemistry 030221 ophthalmology & optometry beta-Alanine Female Ocular Hypertension sense organs Ophthalmic Solutions business Glaucoma Open-Angle |
| Zdroj: | American journal of ophthalmology. 207 |
| ISSN: | 1879-1891 |
| Popis: | To compare the ocular hypotensive efficacy and safety of a fixed-dose combination (FDC) of the Rho kinase inhibitor netarsudil and latanoprost vs monotherapy with netarsudil or latanoprost.Three-month primary endpoint analysis of a randomized, double-masked, phase 3 clinical trial.Adults with open-angle glaucoma or ocular hypertension (unmedicated intraocular pressure [IOP]20 and36 mm Hg at 8:00 AM) were randomized to receive once-daily netarsudil/latanoprost FDC, netarsudil 0.02%, or latanoprost 0.005% for up to 12 months. The primary efficacy endpoint was mean IOP at 8:00 AM, 10:00 AM, and 4:00 PM at week 2, week 6, and month 3.Mean treated IOP ranged from 14.8-16.2 mm Hg for netarsudil/latanoprost FDC, 17.2-19.0 mm Hg for netarsudil, and 16.7-17.8 mm Hg for latanoprost. Netarsudil/latanoprost FDC met the criteria for superiority to each active component at all 9 time points (all P .0001), lowering IOP by an additional 1.8-3.0 mm Hg vs netarsudil and an additional 1.3-2.5 mm Hg vs latanoprost. At month 3, the proportion of patients achieving mean diurnal IOP ≤15 mm Hg was 43.5% for netarsudil/latanoprost FDC, 22.7% for netarsudil, and 24.7% for latanoprost. No treatment-related serious adverse events were reported; treatment-related systemic adverse events were minimal. The most frequent ocular adverse event was conjunctival hyperemia (netarsudil/latanoprost FDC, 53.4%; netarsudil, 41.0%; latanoprost, 14.0%), which led to treatment discontinuation in 7.1% (netarsudil/latanoprost FDC), 4.9% (netarsudil), and 0% (latanoprost) of patients.Once-daily netarsudil/latanoprost FDC demonstrated IOP reductions that were statistically and clinically superior to netarsudil and latanoprost across all 9 time points through month 3, with acceptable ocular safety. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|
Full Text from ScienceDirect