Phase 3, Randomized, 20-Month Study of the Efficacy and Safety of Bimatoprost Implant in Patients with Open-Angle Glaucoma and Ocular Hypertension (ARTEMIS 2)

Bacharach, Jason and Tatham, Andrew and Ferguson, Gloria and Belalcázar, Sandra and Thieme, Hagen and Goodkin, Margot L. and Chen, Michelle Y. and Guo, Qiang and Liu, Jeen and Robinson, Michael R. and Bejanian, Marina and Wirta, David L. and Alezzandrini, Arturo and Bercovich, Gabriel and Deromedis, Pablo and Furno Sola, Federico and Gentile, Carolina and Lerner, Simon and Lupinacci, Anahi and Zeolite, Carlos and Birt, Catherine and Crichton, Andrew and Gagne, Sebastien and Giunta, Michael and Harasymowycz, Paul and Jinapriya, Delan and Nicolela, Marcelo and Nixon, Donald and Saurel, Patrick and Yan, David and Yuen, Darana and Arango, Santiago and Belalcázar, Sandra and Martinez, Alexander and Parra Restrepo, Juan C. and Korda, Vladimir and Kadlecova, Jana and Svacinova, Jitka and Khairy, Hany and El Ibiary, Hani and El Sanabary, Zeinab and Bell, Katharina and Greslechner, Roman and Koch, Jöerg and Lorenz, Katrin and Oberacher-Velten, Isabel and Schmickler, Stefanie and Schuart, Claudie and Thieme, Hagen and Bandello, Francesco and Cagini, Carlos and Figus, Michele and Mastropasqua, Leonardo and Rossetti, Luca and Uva, Maurizio G. and Thayanithi, Sandragasu and Wells, Anthony and Husain, Rahat and Koh, Victor and Lim, Dawn and Tin, Aung and Gous, Petrus and Venter, Lynette and Kee, Changwon and Kook, Michael and Park, Ki-Ho and Eraslan, Muhsin and Kayikcioglu, Ozcan and Yildirim, Nilgun and Bourne, Rupert R. A. and Choudhary, Anshoo and Cordeiro, Francesca and Dubois, Vincent and Kirwan, James and Lim, Sheng and Martin, Keith and Nithy, Antony and Prabhu, Avinash and Tatham, Andrew and Amir, Ahmad and Bacharach, Jason and Barnebey, Howard and Beck, Allen and Bergstrom, Lance and Borisuth, Navaneet and Branch, James D. and Briggs, Jonathan and Bylsma, Stephen and Chang, Peter and Christie, William and Cotter, Frank and Depenbusch, Michael and Goldberg, Damien F. and Greiner, Jack and Gupta, Shailesh and Gutmark, Ron and Han, Ying and Heersink, Sebastian and Kahook, Malik and Khouri, Albert and Kim, Joshua and Kushnick, Howard and Lin, Christopher and Luchs, Jodi and Maharaj, Arindel and Mansberger, Steven L. and Mares, Frank and Miller-Ellis, Eydie and Modi, Satish and Paul, Matthew and Pitha, Ian and Saltzmann, Robert and Sato, Michelle and Savestsky, Michael and Segal, Bruce and Segal, Zachary and Serle, Janet and Sherwood, Mark and Singh, Inder and Smith, Stephen E. and Song, Julia and Sorenson, Robert and Tenkman, Lawrence and Tekwani, Navin and Tubbs, Carl and Tyson, Farrell and Vizzeri, Gianmarco and Vold, Steven and Vu, Qui and Warren, Kimberly S. and Wirta, David (2021) Phase 3, Randomized, 20-Month Study of the Efficacy and Safety of Bimatoprost Implant in Patients with Open-Angle Glaucoma and Ocular Hypertension (ARTEMIS 2). Drugs, 81 (17). pp. 2017-2033. ISSN 1179-1950

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Objective- To evaluate the intraocular pressure (IOP)-lowering efficacy and safety of 10 and 15 µg bimatoprost implant in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT). Methods- This randomized, 20-month, multicenter, masked, parallel-group, phase 3 trial enrolled 528 patients with OAG or OHT and an open iridocorneal angle inferiorly in the study eye. Study eyes were administered 10 or 15 µg bimatoprost implant on day 1, week 16, and week 32, or twice-daily topical timolol maleate 0.5%. Primary endpoints were IOP and IOP change from baseline through week 12. Safety measures included treatment-emergent adverse events (TEAEs) and corneal endothelial cell density (CECD). Results- Both 10 and 15 µg bimatoprost implant met the primary endpoint of noninferiority to timolol in IOP lowering through 12 weeks. Mean IOP reductions from baseline ranged from 6.2–7.4, 6.5–7.8, and 6.1–6.7 mmHg through week 12 in the 10 µg implant, 15 µg implant, and timolol groups, respectively. IOP lowering was similar after the second and third implant administrations. Probabilities of requiring no IOP-lowering treatment for 1 year after the third administration were 77.5% (10 µg implant) and 79.0% (15 µg implant). The most common TEAE was conjunctival hyperemia, typically temporally associated with the administration procedure. Corneal TEAEs of interest (primarily corneal endothelial cell loss, corneal edema, and corneal touch) were more frequent with the 15 than the 10 µg implant and generally were reported after repeated administrations. Loss in mean CECD from baseline to month 20 was ~ 5% in 10 µg implant-treated eyes and ~ 1% in topical timolol-treated eyes. Visual field progression (change in the mean deviation from baseline) was reduced in the 10 µg implant group compared with the timolol group. Conclusions- The results corroborated the previous phase 3 study of the bimatoprost implant. The bimatoprost implant met the primary endpoint and effectively lowered IOP. The majority of patients required no additional treatment for 12 months after the third administration. The benefit-risk assessment favored the 10 over the 15 µg implant. Studies evaluating other administration regimens with reduced risk of corneal events are ongoing. The bimatoprost implant has the potential to improve adherence and reduce treatment burden in glaucoma.

Item Type: Journal Article
Faculty: Faculty of Health, Education, Medicine & Social Care
Depositing User: Lisa Blanshard
Date Deposited: 14 Dec 2021 13:49
Last Modified: 24 Jan 2022 12:12

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