E. Randy Craven
SAN FRANCISCO — A study showed Bimatoprost sustained-release implant was noninferior to timolol and may potentially provide sustained IOP control for patients with open-angle glaucoma or ocular hypertension, according to a speaker here.
“The ARTEMIS implant was able to achieve its primary endpoints, and in fact it looks like it has the possibility of giving us sustained control for out to a year,” E. Randy Craven, MD, said at the American Academy of Ophthalmology annual meeting.
Craven shared the results of the ARTEMIS and APOLLO studies, both of which examined the effects of Bimatoprost SR (Allergan) in patients with glaucoma.
The phase 3 ARTEMIS study included two parallel groups, with 1,122 patients randomly assigned to receive either three Bimatoprost SR 10 µg or 15 µg treatments or topical timolol 0.5% twice daily. The study is ongoing, with approximately 40% of patients completed. Craven presented data of 374 patients treated with Bimatoprost SR 10 µg compared with 374 patients treated with timolol. Each cohort was treated at baseline, and IOP was recorded at week 12, the primary efficacy endpoint of the study. Patients were again treated in both cohorts at weeks 16 and 32 and followed through week 52. At 12 weeks, the mean diurnal IOP was consistently maintained between 16 mm Hg to 17 mm Hg, and the IOP lowering was numerically greater at all six time points in the Bimatoprost SR cohort, Craven said.
The 2-year- phase 1/2 APOLLO study included 75 patients treated with Bimatoprost SR 6 µg, 10 µg, 15 µg, or 20 µg in the study eye and topical bimatoprost 0.3% once daily in the fellow eye. At 16 weeks, Craven said IOP lowering in the Bimatoprost SR cohort was as much as 7.9 mm Hg, with a 32% reduction from baseline.
Additionally, 36% of patients in the APOLLO study experienced IOP control at 1 year with no additional re-treatment or rescue after one administration of Bimatoprost SR 10 µg or 15 µg, while 80% of patients in the ARTEMIS study experienced IOP control 1 year after three administrations of Bimatoprost SR 10 µg, Craven said. – by Robert Linnehan
Craven ER, et al. Phase 3 evaluation of Bimatoprost sustained-release implant in patients with glaucoma or OHT: Results at primary database lock. Presented at: American Academy of Ophthalmology annual meeting; October 11-15, 2019; San Francisco.
Disclosure: Craven reports he is a consultant for Aerie Pharmaceuticals, Alcon Laboratories, Allergan, Ivantis, Santen and W. Gore.