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; Tatham, Andrew J.; Ferguson, Gloria E.; Belalcázar, Sandra; Thieme, Hagen; Goodkin, Margot L.; Chen, Michelle Y.; Guo, Qiang; Liu, Jeen; Robinson, Michael R.; Bejanian, Marina; Wirta, David

doi:10.1007/s40265-021-01624-9

Cited by 33 publications

(56 citation statements)

References 40 publications

(62 reference statements)

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“…Following bimatoprost implant administration, IOP was measured on day 3, then weekly for the first 4 weeks, and every 2 weeks up to week 42, based on clinical evidence indicating that the IOP-lowering effect of the bimatoprost implant can last up to a year in some patients. 4 , 7 , 44 , 45 For each animal, IOP was measured at the same time of day (i.e., 9 AM ±1 h) throughout the study; 3 measurements (each based on 6 consecutive readings automatically obtained and averaged by the tonometer) were taken at each time point, averaged, and used for analysis.…”

Section: Methodsmentioning

confidence: 99%

Intraocular Pressure-Lowering Efficacy of a Sustained-Release Bimatoprost Implant in Dog Eyes Pretreated with Selective Laser Trabeculoplasty

Ghosn

Rajagopalan

Ugarte

et al. 2022

Journal of Ocular Pharmacology and Therapeutics

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Purpose: To assess the intraocular pressure (IOP)-lowering effect of a biodegradable bimatoprost implant following selective laser trabeculoplasty (SLT) in a canine model. Methods: Unilateral SLT was performed in 11 normotensive, treatment-naive beagle dogs. IOP was measured at baseline (pre-SLT) and weekly post-SLT (≤10 weeks). After IOP returned to baseline or at 10 weeks (whichever occurred first), a sustained-release bimatoprost implant was administered bilaterally in the anterior chamber of each animal. IOP was measured weekly for 4 weeks and then every 2 weeks up to week 42. Results: The main outcomes included the IOP change (%) from baseline, calculated in both eyes in the overall population, SLT responder subgroup (defined by peak IOP reduction from baseline ≥3 mmHg or ≥15% for >1 week post-SLT), and SLT nonresponder subgroup (defined by peak IOP reduction from baseline <3 mmHg or <15%). The bimatoprost implant lowered IOP similarly in both the SLT-treated and fellow SLT-naive eyes. Following bimatoprost implant administration, the mean (standard deviation [SD]) peak IOP reduction from baseline was 34.4% (8.5%) in SLT-treated eyes and 35.7% (5.9%) in fellow SLT-naive eyes. The bimatoprost implant lowered IOP comparably ( P > 0.17) in eyes that responded to SLT (mean [SD] peak IOP reduction, 34.6% [10.7%]; n = 6) and those that did not (mean [SD] peak IOP reduction, 34.1% [6.1%]; n = 5). Conclusion: The bimatoprost implant effectively lowered IOP in eyes pretreated with SLT, regardless of response to SLT. The current data suggest that eyes previously treated with SLT can still benefit from the intracameral bimatoprost implant.

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Section: Methodsmentioning

confidence: 99%

Intraocular Pressure-Lowering Efficacy of a Sustained-Release Bimatoprost Implant in Dog Eyes Pretreated with Selective Laser Trabeculoplasty

Ghosn

Rajagopalan

Ugarte

et al. 2022

Journal of Ocular Pharmacology and Therapeutics

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“… 69 The results of a subsequent 20-month, multicenter, phase III clinical trial involving 528 patients showed that a 10 and 15 µg bimatoprost implant was not inferior to 0.5% timolol in terms of IOP-lowering effects. 75 The most common adverse effect was conjunctival congestion. Bimatoprost sustained-release met the target IOP and was effective at lowering IOP.…”

Section: Sustained-release Drug Delivery Systems In Glaucomamentioning

confidence: 99%

Current situation and progress of drugs for reducing intraocular pressure

Liu

Wang

Song

et al. 2022

Therapeutic Advances in Chronic Disease

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Glaucoma, the most common cause of irreversible blindness worldwide, usually causes characteristic optic nerve damage. Pathological intraocular pressure (IOP) elevation is a major risk factor. Drug reduction of IOP is the preferred treatment for clinicians because it can delay the progression of disease. However, the traditional IOP-lowering drugs currently used by patients may be poorly tolerated. Therefore, in recent years, some new drugs have been put into clinical application or in clinical phase I–III studies. They have a better IOP-lowering effect and fewer adverse reactions. Because glaucoma is a chronic disease, drugs need to be administered continuously for a long time. For patients, good compliance and high drug bioavailability have a positive effect on the prognosis of the disease. Therefore, clinicians and scientists have developed drug delivery systems to solve this complex problem. In addition, natural compounds and dietary supplements have a good effect of reducing IOP, and they can also protect the optic nerve through antioxidant action. We summarize the current traditional drugs, new drugs, sustained-release drug delivery systems, and complementary drugs and outline the mechanism of action and clinical effects of these drugs on glaucoma and their recent advances.

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“…A single bimatoprost implant lowered IOP for up to 2 years in some patients in a phase 1/2 clinical study, 4 and in both the ARTEMIS 1 and 2 randomized, masked, phase 3 studies, IOP was controlled in most patients without additional treatment at 1 year after a third bimatoprost implant administration. 1 , 5 Furthermore, in a phase 3 clinical trial study extension, some patients continued to have controlled IOP and stable visual fields more than 3 years after receiving their last implant administration in the ARTEMIS study (Wirta et al, presented at the American Glaucoma Society 2022 Annual Meeting, Nashville, TN). Some patients in the study extension also had remnant implant remaining more than 3 years after receiving their last implant administration.…”

Section: Introductionmentioning

confidence: 99%

“…In each study, one or more residual implants remained visible in the iridocorneal angle on gonioscopy in over 80% of the patients at the month 20 study exit. 1 , 5 The remnant implants were typically estimated to have decreased in size to less than or equal to 25% of their initial size. 1 , 5 …”

Section: Introductionmentioning

confidence: 99%

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Bimatoprost Implant Biodegradation in the Phase 3, Randomized, 20-Month ARTEMIS Studies

Weinreb

Bacharach

Brubaker

et al. 2023

Journal of Ocular Pharmacology and Therapeutics

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Purpose: To evaluate the time course of biodegradation of an intracameral, biodegradable, sustained-release bimatoprost implant that lowers intraocular pressure without the need for daily eye drops. Methods: In 2 identically designed, randomized, phase 3 clinical trials, adults with open-angle glaucoma or ocular hypertension and open iridocorneal angles inferiorly in the study eye were administered 10- or 15-μg bimatoprost implant (day 1 and weeks 16 and 32) or twice-daily topical timolol 0.5%. Implants were assessed on gonioscopy throughout the studies. Investigators reported whether implants were visible, estimated the size of visible implants relative to their initial size at implantation, and reported the implant location. Data for 10-μg implant placed on day 1 were pooled from both studies for analysis. Results: A total of 372 patients received the 10-μg bimatoprost implant. The degree of implant biodegradation at each follow-up time point was variable among patients. The implant frequently swelled during the initial phase of biodegradation from 6 to 28 weeks. Accelerated biodegradation occurred between 31 and 52 weeks, resulting in 82% of implants absent or ≤25% of initial size by 52 weeks. By month 20, 95% of implants had biodegraded to absent or ≤25% of initial size. The implant was predominantly located inferiorly in the iridocorneal angle. Conclusions: Bimatoprost implant biodegradation in phase 3 studies showed some degree of variability among patients. Clinically significant implant biodegradation was observed in the majority of patients by 12 months. Clinical studies are in progress to further understand implant biodegradation and the ideal timing for implant re-administration. NCT02247804; NCT02250651.

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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)

Cited by 33 publications

References 40 publications

Intraocular Pressure-Lowering Efficacy of a Sustained-Release Bimatoprost Implant in Dog Eyes Pretreated with Selective Laser Trabeculoplasty

Intraocular Pressure-Lowering Efficacy of a Sustained-Release Bimatoprost Implant in Dog Eyes Pretreated with Selective Laser Trabeculoplasty

Current situation and progress of drugs for reducing intraocular pressure

Bimatoprost Implant Biodegradation in the Phase 3, Randomized, 20-Month ARTEMIS Studies

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