Phase 3 Studies: Bimatoprost implant yields high responder rates for IOP lowering
In several phase 3 studies using the intracameral sustained-release bimatoprost implant (Durysta, Allergan), more than 45% of patients with open-angle glaucoma (OAG) or ocular hypertension (OH) had ≥30% IOP lowering from baseline at 12 weeks after the first implantation. IOP was reduced and most patients required no additional IOP-lowering treatment, regardless of whether patients previously used 0 to ≥2 topical IOP-lowering medications, according to a presentation at the ASCRS 2021 Annual Meeting.
The researchers evaluated rates of ≥20% IOP-lowering response to the implant in patients who were previously treated with up to greater than 2 topical IOP-lowering medications, and the proportion of patients achieving specified levels of IOP lowering. In the 2 identical, masked, 20-month, studies (n=594 and n=528), patients were randomized to study eye treatment with bimatoprost implant 10 µg or 15 µg (Day 1, Weeks 16 and 32) or topical timolol 0.5% BID. The primary endpoint was IOP lowering through 12 weeks. The proportion of patients achieving at least 20% to 40% IOP lowering at Hour 0 (H0) was evaluated at 2, 6, and 12 weeks after each administration. H0 IOP lowering was also evaluated after stratification by IOP-lowering medication count at screening before washout.
Results demonstrated that baseline H0 mean IOP was comparable among treatment arms (24.47 mm Hg, 24.58 mm Hg, and 24.55 mm Hg for 10-µg implant, 15-µg implant, and timolol, respectively). Overall, the proportion of patients achieving target levels of IOP lowering was consistently numerically higher with 10- µg and 15-µg implant vs timolol in the 12 weeks after the 1st administration.
Craven, ER. Bimatoprost implant for IOP lowering: Responder rates overall and in subgroups by previous medication count in the phase 3 Artemis studies. Presented at: ASCRS 2021 Annual Meeting.