Photo Credit: koldo_studio

The following is a summary of “Phase 3, Randomized, Comparison Study of Intracameral Bimatoprost Implant 10 µg and Selective Laser Trabeculoplasty,” published in the April 2025 issue of American Journal of Ophthalmology by KOLKO et al. 

Researchers conducted a retrospective study to compare the intraocular pressure (IOP) -lowering effect and safety of up to 2 bimatoprost implant administrations with selective laser trabeculoplasty (SLT).  

They performed a Phase 3 (Stage 2), randomized, 24-month, multicenter clinical trial (NCT02507687) with masking for participants and efficacy evaluators. A total of 183 individuals with open-angle glaucoma or ocular hypertension, inadequately managed with topical IOP-lowering medication for reasons other than efficacy, were included, 1 eye underwent a single 360^°  SLT procedure, while the contralateral eye received a 10-µg bimatoprost implant. Initially, a second implant was administered at week 16 if safety criteria were met. Following a protocol amendment, retreatment was performed on a flexible schedule if IOP exceeded 17 mm Hg and safety criteria were met. The primary efficacy outcome was IOP change from baseline at weeks 4, 12, and 24. Safety assessments included treatment-emergent adverse events (TEAEs) and ocular safety measures.  

The results showed that mean (±SE) baseline IOP was 25.2 ± 0.22 mm Hg in implant-treated eyes and 25.1 ± 0.22 mm Hg in SLT-treated eyes. Least-squares mean (±SE) IOP reduction (mm Hg) in eyes treated with up to 2 bimatoprost implants vs SLT was 6.8 ± 0.28 vs 6.2 ± 0.28 at week 4, 6.9 ± 0.30 vs 6.4 ± 0.30 at week 12, and 6.9 ± 0.27 vs 6.5 ± 0.28 at week 24. The probability of not requiring nonstudy (rescue) IOP-lowering treatment at days 360 and 720 was 67.5% and 50.2% for implant-treated eyes vs 68.7% and 60.6% for SLT-treated eyes. The most frequent ocular TEAE in both groups were increased IOP due to waning efficacy. Mean (±SE) percentage change in corneal endothelial cell density from baseline at month 24 was −6.2 ± 1.13% in implant-treated eyes (−7.9 ± 2.04% with fixed readministration; −5.2 ± 1.35% with flexible readministration) vs −3.1 ± 0.43% in SLT-treated eyes.  

Investigators concluded that the bimatoprost implant demonstrated statistical and clinical noninferiority to SLT in reducing IOP from baseline at weeks 4, 12, and 24, a finding supported by subgroup analysis in patients with flexible implant readministration, and both interventions showed sustained IOP lowering over 2 years, with a flexible administration schedule improving the implant’s safety profile compared to a fixed schedule. 

Source: ajo.com/article/S0002-9394(25)00003-0/fulltext