Details

Autor(en) / Beteiligte

• Asrani, Sanjay
• Robin, Alan L.
• Serle, Janet B.
• Lewis, Richard A.
• Usner, Dale W.
• Kopczynski, Casey C.
• Heah, Theresa
• Ackerman, Stacey L.
• Alpern, Louis M.
• Bashford, Kent
• Bluestein, Ettaleah C.
• Boyce, James D.
• Branch, James D.
• Brubaker, Jacob W.
• Christie, William C.
• Cohen, John S.
• Collins, Nicole M.
• Corin, Scott M.
• Daynes, Todd Ellsworth
• Depenbusch, Michael
• Dixon, El-Roy
• Duzman, Eran
• Flowers, Brian E.
• Flynn, William J.
• Fong, Raymond
• Gira, Joseph P.
• Goldberg, Damien F.
• Greene, Brennan
• Han, Scott B.
• Henderson, Thomas T.
• Jerkins, Gary
• Jong, Kevin Y.
• Katzen, Lawrence B.
• Khemsara, Vickas
• Klugo, Karen L.
• Kozlovsky, John F.
• Leonardo, Donna
• Liu, Yao
• LoBue, Thomas D.
• Luchs, Jodi Ian
• Malhotra, Ranjan P.
• Mays, Andrew
• McLaurin, Eugene B.
• McMenemy, Matthew G.
• Modi, Satish
• Moroi, Sayoko
• Mulaney, Jay
• Nagi, Kundandeep
• Nicolau, John
• Parikh, Mihir
• Patel, Jay R.
• Peplinski, Lee S.
• Perez, Bernard R.
• Piltz-Seymour, Jody
• Sadri, Ehsan
• Saltzmann, Robert M.
• Schenker, Howard I.
• Swanic, Matthew J.
• Tekwani, Navin
• Teymoorian, Savak
• Thomas, Justus W.
• Tyson, Farrell C.
• Vold, Stephen
• Weiss, Mark J.
• Zaman, Fiaz

Titel

Netarsudil/Latanoprost Fixed-Dose Combination for Elevated Intraocular Pressure: Three-Month Data from a Randomized Phase 3 Trial

Ist Teil von

• American journal of ophthalmology, 2019-11, Vol.207, p.248-257

Ort / Verlag

United States: Elsevier Inc

Erscheinungsjahr

2019

Quelle

MEDLINE

Beschreibungen/Notizen

• 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 and <36 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.