Study evaluates rate of implant bimatoprost biodegradation
The estimated mean size of 10-µg bimatoprost implant (Durysta, Allergan) administered on Day 1 in phase 3 trials decreases according to an exponential function. This information can be used to predict the size of a single- or multiple implants in the anterior chamber and help determine the ideal timing for implant re-administration, according to a recent study presented at ARVO 2021.
Researchers evaluated the rate of biodegradation of the bimatoprost implant in two 20-month randomized, controlled in the phase 3 ARTEMIS clinical trials. The implant 10 µg is a biodegradable, intracameral implant that releases bimatoprost steadily for about 4 months to lower IOP and then converts to water and CO2. The polymers in the implant matrix may last longer. In the trials, 1 eye per patient with open-angle glaucoma or ocular hypertension was randomized to an intracameral 10- or 15-µg bimatoprost implant administered on Day 1, Weeks 16 and 32 or topical timolol 0.5% BID. Gonioscopy was used to estimated implant size as a percentage of the initial size. Data was pooled for the 10-µg implants placed on Day 1 in both trials for analysis.
For the 230 eyes included, the estimated mean percentage decrease in implant size from baseline was 24.1% at Week 28 and 80.2% at Week 52. The estimated mean rate of implant biodegradation was 3.7%/month through Week 28, 10.2%/month after Week 28 through Week 52, and 2.4%/month after Week 52 through Month 20. Further clinical studies are underway to further evaluate implant biodegradation and implant re-administration timing, the researchers said.
Brubaker JW, et al. Rate of bimatoprost implant biodegradation in the phase 3 ARTEMIS studies. Presented at: ARVO 2021.