Abstract
Purpose: To compare the intraocular pressure (IOP)-lowering efficacy and safety of netarsudil once daily (QD) and timolol twice daily (BID). Design: Double-masked, randomized, phase 3, noninferiority study. Methods: Patients with open-angle glaucoma or ocular hypertension (unmedicated baseline IOP >20 to <30 mm Hg at 8:00 AM) were randomized to netarsudil ophthalmic solution 0.02% QD (PM) or timolol ophthalmic solution 0.5% BID. The primary endpoint was mean IOP at 8:00 AM, 10:00 AM, and 4:00 PM at week 2, week 6, and month 3 in patients with baseline IOP <25 mm Hg (per-protocol population). Safety was recorded over the 6-month treatment period. Results: A total of 186 patients from each treatment arm were included in the primary efficacy analysis. Netarsudil QD met the criteria for noninferiority to timolol BID. Mean treated IOP ranged from 16.3 to 17.9 mm Hg for netarsudil and 16.7 to 17.6 for timolol, with mean reductions from baseline of 3.9 to 4.7 mm Hg and 3.8 to 5.2 mm Hg, respectively. In prespecified secondary analyses, netarsudil demonstrated noninferiority to timolol in patients with baseline IOP <27 mm Hg and <30 mm Hg. The IOP-lowering effects of netarsudil were sustained over 6 months of treatment. No treatment-related serious adverse event (AE) was reported for either study drug. However, statistically significant reductions in mean heart rate were recorded at all study visits for the timolol group. The most frequent ocular AE among netarsudil-treated patients was conjunctival hyperemia (47.9%), which was predominately mild. Conclusions: Netarsudil QD (PM), a first-in-class IOP-lowering medication, was noninferior to timolol BID and was associated with tolerable ocular AEs.
| Original language | English |
|---|---|
| Pages (from-to) | 97-104 |
| Number of pages | 8 |
| Journal | American Journal of Ophthalmology |
| Volume | 204 |
| DOIs | |
| State | Published - Aug 2019 |
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Once-Daily Netarsudil Versus Twice-Daily Timolol in Patients With Elevated Intraocular Pressure : The Randomized Phase 3 ROCKET-4 Study. / Rocket-4 Study Group.
In: American Journal of Ophthalmology, Vol. 204, 08.2019, p. 97-104.Research output: Contribution to journal › Article › peer-review
TY - JOUR
T1 - Once-Daily Netarsudil Versus Twice-Daily Timolol in Patients With Elevated Intraocular Pressure
T2 - The Randomized Phase 3 ROCKET-4 Study
AU - Rocket-4 Study Group
AU - Khouri, Albert S.
AU - Serle, Janet B.
AU - Bacharach, Jason
AU - Usner, Dale W.
AU - Lewis, Richard A.
AU - Braswell, Puiwah
AU - Kopczynski, Casey C.
AU - Heah, Theresa
AU - Benza, Robert
AU - Boyle, John W.
AU - Butler, Michelle
AU - Cacioppo, Leonard Robert
AU - Cardona, Jose F.
AU - Colborn, Valerie A.
AU - Day, Douglas G.
AU - Douglass, David T.
AU - El-Harazi, Sherif M.
AU - Ghate, Deepta
AU - Hartman, Carl
AU - Haverly, Robert F.
AU - Katzman, Barry
AU - Kim, Max
AU - Koo, Edward Y.
AU - Korenfeld, Michael S.
AU - Kwapiszeski, Bradley
AU - Lane, Lydia
AU - Lin, Christopher
AU - Logan, Andrew Gardner
AU - Lozier, Jeffrey Raymond
AU - McQuirter, Henry
AU - Mundorf, Thomas K.
AU - Olander, Kenneth
AU - Ou, Richard J.
AU - Panzo, Gregory J.
AU - Peace, James H.
AU - Protzko, Eugene E.
AU - Ritch, Robert
AU - Sall, Kenneth
AU - Schechter, Barry A.
AU - Seltzer, Samuel Eric
AU - Shah, Pankajkumar G.
AU - Sharpe, Elizabeth
AU - Lee Shettle, Philip
AU - Shulman, David G.
AU - Singh, Inder Paul
AU - Smith, Stacy R.
AU - Smith, Stephen E.
AU - Smyth-Medina, Robert John
AU - Sorenson, Robert C.
AU - Sturm, Richard
N1 - Funding Information: Other Acknowledgments: Support for third-party writing assistance for this manuscript was provided by Tiffany DeSimone, PhD, of CodonMedical, an Ashfield Company, part of UDG Healthcare plc, and was funded by Aerie Pharmaceuticals,Inc . Funding Information: Funding/Support: This work was funded by Aerie Pharmaceuticals,Inc , Irvine, California, USA, who participated in the design and conduct of the study; data collection, management, and interpretation; and preparation, review, and approval of the manuscript. Financial Disclosures: Albert S. Khouri: research grant support from Allergan , Aerie Pharmaceuticals , and the New Jersey Health Foundation ; Speakers' bureaus for Novartis, Allergan, and Glaukos Corporation; consultant to Topcon Medical Systems. Janet B. Serle: advisory boards for Aerie Pharmaceuticals; consultant to Allergan and Bausch + Lomb; research support from Allergan and Ocular Therapeutix ; stocks in Aerie Pharmaceuticals. Jason Bacharach: research support from Aerie Pharmaceuticals , Allergan , Novartis , Glaukos Corporation , Heidelberg Optovue , and Ocular Therapeutix ; speakers' bureaus for Aerie Pharmaceuticals, Alcon, Allergan, Glaukos Corporation, New World Medical, and Bausch + Lomb; consultant to Aerie Pharmaceuticals, Alcon, Allergan, Bausch + Lomb, Optovue, Injectsense, and New World Medical; medical monitor for Topcon. Dale W. Usner: paid statistical consultant to Aerie Pharmaceuticals. Richard A. Lewis, Puiwah Braswell, Casey C. Kopczynski, and Theresa Heah are employees of and own stocks in Aerie Pharmaceuticals. The authors attest that they meet the current ICMJE criteria for authorship. Funding Information: Funding/Support: This work was funded by Aerie Pharmaceuticals,Inc, Irvine, California, USA, who participated in the design and conduct of the study; data collection, management, and interpretation; and preparation, review, and approval of the manuscript. Financial Disclosures: Albert S. Khouri: research grant support from Allergan, Aerie Pharmaceuticals, and the New Jersey Health Foundation; Speakers' bureaus for Novartis, Allergan, and Glaukos Corporation; consultant to Topcon Medical Systems. Janet B. Serle: advisory boards for Aerie Pharmaceuticals; consultant to Allergan and Bausch + Lomb; research support from Allergan and Ocular Therapeutix; stocks in Aerie Pharmaceuticals. Jason Bacharach: research support from Aerie Pharmaceuticals, Allergan, Novartis, Glaukos Corporation, Heidelberg Optovue, and Ocular Therapeutix; speakers' bureaus for Aerie Pharmaceuticals, Alcon, Allergan, Glaukos Corporation, New World Medical, and Bausch + Lomb; consultant to Aerie Pharmaceuticals, Alcon, Allergan, Bausch + Lomb, Optovue, Injectsense, and New World Medical; medical monitor for Topcon. Dale W. Usner: paid statistical consultant to Aerie Pharmaceuticals. Richard A. Lewis, Puiwah Braswell, Casey C. Kopczynski, and Theresa Heah are employees of and own stocks in Aerie Pharmaceuticals. The authors attest that they meet the current ICMJE criteria for authorship. Other Acknowledgments: Support for third-party writing assistance for this manuscript was provided by Tiffany DeSimone, PhD, of CodonMedical, an Ashfield Company, part of UDG Healthcare plc, and was funded by Aerie Pharmaceuticals,Inc. ROCKET-4 Study Investigators: Jason Bacharach (North Bay Eye Associates, Inc, Petaluma, California, USA), Robert Benza (Apex Eye, Cincinnati, Ohio, USA), John W. Boyle IV (Gulf South Eye Associates, Metairie, Louisiana, USA), Michelle Butler (Glaucoma Associates of Texas, Dallas, Texas, USA), Leonard Robert Cacioppo (Hernando Eye Institute, Brooksville, Florida, USA), Jose F. Cardona (Indago Research and Health Center, Inc, Hialeah, Florida, USA), Valerie A. Colborn (Colborn Eye Care, Lillington, North Carolina, USA), Douglas G. Day (Coastal Research Associates, LLC, Roswell, Georgia, USA), David T. Douglass (Eye Center Northeast, Bangor, Maine, USA), Sherif M. El-Harazi (Lugene Eye Institute, Glendale, California, USA), Deepta Ghate (UNMC-Truhlsen Eye Institute, Omaha, Nebraska, USA), Carl Hartman (Southern California Eye Physicians and Associates, Long Beach, California, USA), Robert F. Haverly (Laser Eye Surgery of Erie, Erie, Pennsylvania, USA), Barry Katzman (West Coast Eye Care Associates, San Diego, California, USA), Max Kim (Arizona Glaucoma Specialists, Phoenix, Arizona, USA), Edward Y. Koo (Peninsula Ophthalmology Group, Burlingame, California, USA), Michael S. Korenfeld (Comprehensive Eye Care, Ltd, Washington, Missouri, USA), Bradley Kwapiszeski (Heart of America Eye Care, Shawnee Mission, Kansas, USA), Lydia Lane (Little Rock Eye Clinic, LLP, Little Rock, Arkansas, USA), Christopher Lin (Shasta Eye Medical Group, Inc, Redding, California, USA), Andrew Gardner Logan (Logan Ophthalmic Research, LLC, Tamarac, Florida, USA), Jeffrey Raymond Lozier (Arch Health Partners, Poway, California, USA), Henry McQuirter (Eye Specialty Group, Memphis, Tennessee, USA), Thomas K. Mundorf (Mundorf Eye Center, Charlotte, North Carolina, USA), Kenneth Olander (University Eye Specialists, Maryville, Tennessee, USA), Richard J. Ou (Houston Eye Associates, Houston, Texas, USA), Gregory J. Panzo (Mid Florida Eye Center, PA, Mount Dora, Florida, USA), James H. Peace (United Medical Research Institute, Inglewood, California, USA), Eugene E. Protzko (Seidenberg Protzko Eye Associates, Havre de Grace, Maryland, USA), Robert Ritch (New York Eye and Ear Infirmary, New York, New York, USA), Kenneth Sall (Sall Research Medical Center, Artesia, California, USA), Barry A. Schechter (Florida Eye Microsurgical Institute, Inc, Boynton Beach, Florida, USA), Samuel Eric Seltzer (Carolinas Centers for Sight, PC, Florence, South Carolina, USA), Pankajkumar G. Shah (DCT-Shah Research, LLC, Mission, Texas, USA), Elizabeth Sharpe (Glaucoma Consultants and Center for Eye Research PA, Mt. Pleasant, South Carolina, USA), Philip Lee Shettle (Shettle Eye Research, Inc, Largo, Florida, USA), David G. Shulman (San Antonio, Texas, USA), Inder Paul Singh (The Eye Center of Racine and Kenosha Ltd, Kenosha, Wisconsin, USA), Stacy R. Smith (Mountain Valley Eye Institute, Salt Lake City, Utah, USA), Stephen E. Smith (Eye Associates of Fort Myers, Fort Myers, Florida, USA), Robert John Smyth-Medina (North Valley Eye Medical Group, Inc, Mission Hills, California, USA), Robert C. Sorenson (Inland Eye Specialists, Hemet, California, USA), Richard Sturm (Ophthalmic Consultants of Long Island, Lynbrook, New York, USA), Gregory M. Sulkowski (Taustine Eye Center, Louisville, Kentucky, USA), James D. Sutton (Mississippi Eye Associates, Ocean Springs, Mississippi, USA), Michael Tepedino (Cornerstone Eye Care, High Point, North Carolina, USA), Julie Tsai (Alamo Foot & Eye Clinic, San Antonio, Texas, USA), Carl B. Tubbs (Glaucoma Consultants of Colorado DBA Insight Vision Group, Parker, Colorado, USA), David B. Tukel (Tukel-Kozlow Eye Center, Dearborn, Michigan, USA), Thomas Richard Walters (Texan Eye, PA/Keystone Research, Ltd, Austin, Texas, USA), David L. Wirta (Eye Research Foundation, Newport Beach, California, USA). Publisher Copyright: © 2019 The Author(s)
PY - 2019/8
Y1 - 2019/8
N2 - Purpose: To compare the intraocular pressure (IOP)-lowering efficacy and safety of netarsudil once daily (QD) and timolol twice daily (BID). Design: Double-masked, randomized, phase 3, noninferiority study. Methods: Patients with open-angle glaucoma or ocular hypertension (unmedicated baseline IOP >20 to <30 mm Hg at 8:00 AM) were randomized to netarsudil ophthalmic solution 0.02% QD (PM) or timolol ophthalmic solution 0.5% BID. The primary endpoint was mean IOP at 8:00 AM, 10:00 AM, and 4:00 PM at week 2, week 6, and month 3 in patients with baseline IOP <25 mm Hg (per-protocol population). Safety was recorded over the 6-month treatment period. Results: A total of 186 patients from each treatment arm were included in the primary efficacy analysis. Netarsudil QD met the criteria for noninferiority to timolol BID. Mean treated IOP ranged from 16.3 to 17.9 mm Hg for netarsudil and 16.7 to 17.6 for timolol, with mean reductions from baseline of 3.9 to 4.7 mm Hg and 3.8 to 5.2 mm Hg, respectively. In prespecified secondary analyses, netarsudil demonstrated noninferiority to timolol in patients with baseline IOP <27 mm Hg and <30 mm Hg. The IOP-lowering effects of netarsudil were sustained over 6 months of treatment. No treatment-related serious adverse event (AE) was reported for either study drug. However, statistically significant reductions in mean heart rate were recorded at all study visits for the timolol group. The most frequent ocular AE among netarsudil-treated patients was conjunctival hyperemia (47.9%), which was predominately mild. Conclusions: Netarsudil QD (PM), a first-in-class IOP-lowering medication, was noninferior to timolol BID and was associated with tolerable ocular AEs.
AB - Purpose: To compare the intraocular pressure (IOP)-lowering efficacy and safety of netarsudil once daily (QD) and timolol twice daily (BID). Design: Double-masked, randomized, phase 3, noninferiority study. Methods: Patients with open-angle glaucoma or ocular hypertension (unmedicated baseline IOP >20 to <30 mm Hg at 8:00 AM) were randomized to netarsudil ophthalmic solution 0.02% QD (PM) or timolol ophthalmic solution 0.5% BID. The primary endpoint was mean IOP at 8:00 AM, 10:00 AM, and 4:00 PM at week 2, week 6, and month 3 in patients with baseline IOP <25 mm Hg (per-protocol population). Safety was recorded over the 6-month treatment period. Results: A total of 186 patients from each treatment arm were included in the primary efficacy analysis. Netarsudil QD met the criteria for noninferiority to timolol BID. Mean treated IOP ranged from 16.3 to 17.9 mm Hg for netarsudil and 16.7 to 17.6 for timolol, with mean reductions from baseline of 3.9 to 4.7 mm Hg and 3.8 to 5.2 mm Hg, respectively. In prespecified secondary analyses, netarsudil demonstrated noninferiority to timolol in patients with baseline IOP <27 mm Hg and <30 mm Hg. The IOP-lowering effects of netarsudil were sustained over 6 months of treatment. No treatment-related serious adverse event (AE) was reported for either study drug. However, statistically significant reductions in mean heart rate were recorded at all study visits for the timolol group. The most frequent ocular AE among netarsudil-treated patients was conjunctival hyperemia (47.9%), which was predominately mild. Conclusions: Netarsudil QD (PM), a first-in-class IOP-lowering medication, was noninferior to timolol BID and was associated with tolerable ocular AEs.
UR - http://www.scopus.com/inward/record.url?scp=85067617969&partnerID=8YFLogxK
U2 - 10.1016/j.ajo.2019.03.002
DO - 10.1016/j.ajo.2019.03.002
M3 - Article
C2 - 30862500
AN - SCOPUS:85067617969
VL - 204
SP - 97
EP - 104
JO - American Journal of Ophthalmology
JF - American Journal of Ophthalmology
SN - 0002-9394
ER -