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Phase 3, Randomized, 20-Month Study of Bimatoprost Implant in Open-Angle Glaucoma and Ocular Hypertension (ARTEMIS 1)

2020; Elsevier BV; Volume: 127; Issue: 12 Linguagem: Inglês

10.1016/j.ophtha.2020.06.018

1549-4713

Felipe A. Medeiros, Thomas R. Walters, Miriam Kolko, Michael Coote, Marina Bejanian, Margot L. Goodkin, Qiang Guo, Jane Zhang, Michael R. Robinson, Robert N. Weinreb, Ashish Agar, Michael Coote, Renuka Bathijia, Lance Liu, Tim Roberts, Christoph Faschinger, Clemens Vass, Nathalie Collignon, Ana Cláudia Alves Pereira, Rubens Belfort de Mattos, Fernando Justino Dantas, M. J. Silva, Fábio Nishimura Kanadani, Leopoldo Magacho dos Santos Silva, Tiago Prata, Daniella Bach‐Holm, Miriam Kolko, Jimmy Lai, Clement C. Tham, György Bátor, Lajos Szalczer, Balázs Varsányi, Eytan Z. Blumenthal, Orna Geyer, Shmuel Lavartovsky, Tamar Pedut-Kloizman, Nir Shoham-Hazon, Silvio Lujan, Benjamin Abela, Robert Edward T. Ang, Edgar U. Leuenberger, Harvey S. Uy, Maria Imelda R. Yap-Veloso, Piotr Fryczkowski, Piotr Jurowski, Bartłomiej J. Kałużny, Józef Kalużny, Marta Misiuk‐Hojło, Krystyna Raczyńska, Wioletta Tomczyk-Dorozynska, J Wasyluk, S Zalewski, Tomasz Żarnowski, J. García–Sánchez, R. Giménez-Gómez, Elena Millà Griñó, Alfonso Antón López, Merce Guarro Miralles, Javier Montero Moreno, Vicente Polo, Enrique Cervera Taulet, Beatriz Ponte, Yingying Chen, Yuan‐Chieh Lee, Louis Alpern, Michael S. Berlin, Jacob W. Brubaker, Delmar R. Caldwell, Andrew Camp, Louis B. Cantor, Ronald Caronia, Charles J. Crane, Douglas G. Day, Eran Duzman, John L Elfervig, Shérif M. El-Harazi, Richard Evans, Ann C. Fisher, William J. Flynn, C. Stephen Foster, R. E. P. Frenkel, Raj Goyal, Ronald L. Gross, Paul J. Hartman, William L. Haynes, Gary Jerkins, Janet Kim, Max Kim, Bradley Kwapiszeski, Benjamin Lambright, Christine L. Larsen, James D. Lehmann, Jeffrey Levenson, Dwayne K. Logan, Brian McMillan, Joseph R. Martel, Hylton R. Mayer, Felipe A. Medeiros, Sayoko E. Moroi, Andrew L. Moyes, Jonathan S. Myers, John P. Nairn, Steven O. Nielsen, Don Perez Ortiz, James D. Paauw, V. Pai, Joseph F. Panarelli, A.J. Park, Mujtaba A. Qazi, Nikola Ragusa, Douglas J. Rhee, Robert Rothman, Reginald Sampson, Samuel Eric Seltzer, Anurag Shrivastava, Steven T. Simmons, Annette Chang Sims, Mark Slabaugh, Scott Smetana, Oluwatosin Smith, Scott C. So, Ingeborg Stalmans, J. Shanti Swarup, Jay Wallshein, Thomas R. Walters, Fiaz Zaman, Rui Zhang,

Ocular Surface and Contact Lens

To evaluate the intraocular pressure (IOP)-lowering efficacy and safety of 10- and 15-μg bimatoprost implant in subjects with open-angle glaucoma (OAG) and ocular hypertension (OHT) after initial and repeated administrations.Randomized, 20-month, multicenter, subject- and efficacy evaluator-masked, parallel-group, phase 3 clinical study.Adults with OAG or OHT in each eye, open iridocorneal angle inferiorly in the study eye, and study eye baseline IOP (hour 0; 8 am) of 22-32 mmHg after washout.Study eyes received bimatoprost implant 10 μg (n = 198) or 15 μg (n = 198) on day 1 with readministration at weeks 16 and 32, or twice-daily topical timolol maleate 0.5% (n = 198). Intraocular pressure was measured at hours 0 and 2 at each visit.Primary end points were IOP and change from baseline IOP through week 12. Safety measures included treatment-emergent adverse events (TEAEs) and corneal endothelial cell density (CECD).Both dose strengths of bimatoprost implant were noninferior to timolol in IOP lowering after each administration. Mean diurnal IOP was 24.0, 24.2, and 23.9 mmHg at baseline and from 16.5-17.2, 16.5-17.0, and 17.1-17.5 mmHg through week 12 in the 10-μg implant, 15-μg implant, and timolol groups, respectively. The incidence of corneal and inflammatory TEAEs of interest (e.g., corneal endothelial cell loss, iritis) was higher with bimatoprost implant than timolol and highest with the 15-μg dose strength. Incidence of corneal TEAEs increased after repeated treatment; with 3 administrations at fixed 16-week intervals, incidence of ≥20% CECD loss was 10.2% (10-μg implant) and 21.8% (15-μg implant). Mean best-corrected visual acuity (BCVA) was stable; 3 implant-treated subjects with corneal TEAEs had >2-line BCVA loss at their last visit.Both dose strengths of bimatoprost implant met the primary end point of noninferiority to timolol through week 12. One year after 3 administrations, IOP was controlled in most subjects without additional treatment. The risk-benefit assessment favored the 10-μg implant over the 15-μg implant. Ongoing studies are evaluating other administration regimens to reduce the potential for CECD loss. The bimatoprost implant has potential to improve adherence and reduce treatment burden in glaucoma.