Bimatoprost implant lowers IOP at 15 weeks in study
One administration of sustained-release bimatoprost implant 10 μg (BimSR, Durysta, AbbVie Inc) effectively lowered IOP for 15 weeks with an acceptable corneal safety profile and potential for an extended duration of effect, according to a poster presented at AAO 2020 Virtual.
Researchers reported outcomes after a single administration of BimSR in open-angle glaucoma and ocular hypertension. The study included new analyses of IOP (Hour 0, 8 AM), need for rescue medications, and corneal endothelial cell loss in phase 1/2 and phase 3 studies.
In phase 1/2 study (n=21; 13 with 1 administration and 8 with 2 administrations), no patient had an adverse event report of corneal endothelial cell loss. In phase 3 studies, mean ± SD IOP for BimSR (n=374) vs timolol 0.5% b.i.d. (n=374) was 24.5 ± 2.6 mm Hg vs 24.5± 2.6 mm Hg at baseline, decreasing to 17.4±4.0 mm Hg vs 17.7 ± 3.8 mm Hg at Week 12. In addition, 0.9% of BimSR patients had corneal endothelial cell loss between 10% and 20% v 2.0% of timolol patients, and none had ≥20% corneal endothelial cell loss. At Week 15 (final IOP measurement after single administration) BimSR patients had a mean IOP of 18.8 ± 4.4 mm Hg. Sixty-one percent of patients had ≥20% IOP lowering, and only 2.1% had been rescued. Overall the corneal safety profile was acceptable in all phases of the studies. Additional studies are ongoing to determine optimum intervals of re-administration.
Medeiros FA, et al. Single administration of intracameral bimatoprost Implant 10 μg: IOP lowering and safety. Presented at: AAO 2020 Virtual [Session: PO181].