gms | German Medical Science

Purpose: To evaluate safety and duration of intraocular pressure (IOP)-lowering effect after single and repeat administration of intracameral 10-µg bimatoprost implant in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT).

Methods: Ongoing (enrollment completed), open-label, multicenter study (NCT03850782) evaluating outcomes of as-needed administrations of bimatoprost implant in patients with OAG or OHT inadequately managed with topical IOP-lowering medication for reasons other than efficacy. IOP-lowering rescue treatment is allowed if retreatment criteria are not met. Primary endpoint is time to rescue/retreatment after the initial implant administration analyzed by Kaplan-Meier method. Safety measures include treatment-emergent adverse events (TEAEs) and reading-center evaluation of corneal endothelial cell density (CECD). Data collected through 13-January-2023 from patients who received up to 2 implant administrations were analyzed.

Results: In total, 423 patients received 10-µg bimatoprost implant on day 1 (Cycle 1), 123 patients also received a second administration (Cycle 2), and 215 patients had IOP data available through month 12. Median time (95% CI) from the first implant administration to either a second administration or rescue treatment was 379 (362, 512) days; cumulative probability of not requiring a second administration or rescue treatment by day 360 was 56.5%. A second implant administration also provided a long duration of IOP control. Mean change from baseline IOP in non-rescued eyes (mmHg) was -7.3 at week 24 and -6.2 at month 12. The most common ocular TEAEs in study eyes were conjunctival hyperemia (Cycle 1: 12.8%; Cycle 2: 10.6%) known to be associated with administration procedure and increased IOP (Cycle 1: 8.5%; Cycle 2: 14.6%). Mean (±SE) % change from baseline in CECD at 12 months after implant administration was -3.5±0.80% in Cycle 1 and -10.4±3.15% in Cycle 2. The Cycle 1 implant was no longer visible or ≤25% of initial size in 69.8% and 97.7% of study eyes at months 12 and 24, respectively.

Conclusion: In this interim analysis based on available data, the IOP-lowering effect of the initial bimatoprost implant administration was well maintained for >1 year in most patients, with similar results after the second implant. The safety profile of as-needed administration was acceptable.