Safety and IOP outcomes after single administration of 10 µg bimatoprost implant in one eye and SLT in the contralateral eye

Abstract

Purpose : To evaluate the safety and intraocular pressure (IOP)-lowering effect of intracameral bimatoprost implant single administration vs selective laser trabeculoplasty (SLT) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT).

Methods : Phase 3, randomized, masked, paired-eye study in patients with OAG or OHT inadequately managed with topical IOP-lowering medication for reasons other than efficacy (NCT02507687). Patients received 360° SLT in one eye and up to 2 administrations of 10 µg bimatoprost implant in the contralateral eye. Initially, all implant-treated eyes received a 2nd implant at week 16 if safety criteria were met. After a protocol amendment, implant-treated eyes were retreated with flexible scheduling only if the IOP was >17 mmHg. IOP was analyzed for the subgroup of patients who did not receive retreatment or rescue during the first 24 weeks after the initial implant administration. The key efficacy variable was IOP change from baseline; safety measures included treatment-emergent adverse events (TEAEs) and corneal endothelial cell density (CECD). The analysis of safety outcomes after single administration used data collected for both eyes up until the patient received a 2nd implant administration.

Results : Mean (±SE) IOP at baseline was 25.2±0.22 mmHg in implant-treated eyes and 25.1±0.22 mmHg in SLT-treated eyes. Mean (±SE) IOP reduction from baseline (mmHg) at weeks 4, 12, and 24, respectively, was 6.9±0.29 (n=170), 7.1±0.32 (n=156), and 6.9±0.65 (n=45) in implant-treated eyes and 6.3±0.28 (n=168), 6.5±0.29 (n=149), and 7.3±0.44 (n=46) in SLT-treated eyes (Figure). Percentage of eyes with ≥20% IOP reduction from baseline at weeks 4, 12, and 24, respectively, was 71.2%, 71.8%, and 71.1% with implant and 68.5%, 71.1%, and 84.8% with SLT. The most common ocular TEAEs were conjunctival hyperemia, punctate keratitis, dry eye, and increased IOP for both implant- and SLT-treated eyes. Corneal endothelial cell loss was reported for 1.7% of implant-treated and 2.2% of SLT-treated eyes. Mean (±SE) % change from baseline in CECD at week 52 was −3.7±1.88% in implant-treated and −2.7±0.55% in SLT-treated eyes.

Conclusions : Bimatoprost implant single administration and SLT both effectively lowered IOP. Both treatments demonstrated similar, favorable safety profiles.

This abstract was presented at the 2024 ARVO Annual Meeting, held in Seattle, WA, May 5-9, 2024.

 

Change from baseline IOP after a single implant administration or SLT