Phase 3, Randomized, 20-Month Study of the Efficacy and Safety of Bimatoprost Implant in Patients with Open-Angle Glaucoma and Ocular Hypertension (ARTEMIS 2)

Objective- To evaluate the intraocular pressure (IOP)-lowering efficacy and safety of 10 and 15 µg bimatoprost implant in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT). Methods- This randomized, 20-month, multicenter, masked, parallel-group, phase 3 trial enrolled 528 patients with OAG or OHT and an open iridocorneal angle inferiorly in the study eye. Study eyes were administered 10 or 15 µg bimatoprost implant on day 1, week 16, and week 32, or twice-daily topical timolol maleate 0.5%. Primary endpoints were IOP and IOP change from baseline through week 12. Safety measures included treatment-emergent adverse events (TEAEs) and corneal endothelial cell density (CECD). Results- Both 10 and 15 µg bimatoprost implant met the primary endpoint of noninferiority to timolol in IOP lowering through 12 weeks. Mean IOP reductions from baseline ranged from 6.2–7.4, 6.5–7.8, and 6.1–6.7 mmHg through week 12 in the 10 µg implant, 15 µg implant, and timolol groups, respectively. IOP lowering was similar after the second and third implant administrations. Probabilities of requiring no IOP-lowering treatment for 1 year after the third administration were 77.5% (10 µg implant) and 79.0% (15 µg implant). The most common TEAE was conjunctival hyperemia, typically temporally associated with the administration procedure. Corneal TEAEs of interest (primarily corneal endothelial cell loss, corneal edema, and corneal touch) were more frequent with the 15 than the 10 µg implant and generally were reported after repeated administrations. Loss in mean CECD from baseline to month 20 was ~ 5% in 10 µg implant-treated eyes and ~ 1% in topical timolol-treated eyes. Visual field progression (change in the mean deviation from baseline) was reduced in the 10 µg implant group compared with the timolol group. Conclusions- The results corroborated the previous phase 3 study of the bimatoprost implant. The bimatoprost implant met the primary endpoint and effectively lowered IOP. The majority of patients required no additional treatment for 12 months after the third administration. The benefit-risk assessment favored the 10 over the 15 µg implant. Studies evaluating other administration regimens with reduced risk of corneal events are ongoing. The bimatoprost implant has the potential to improve adherence and reduce treatment burden in glaucoma

Comparison between post treatment vascular density, fractal dimension and choriocapillaris flow in ischemic and non-ischemic retinal vein occlusion using optical coherence tomography angiography

The aim of the study was to compare vascular density (VD), fractal dimension (FD), foveal avascular zone (FAZ) and choriocapillaris flow and using optical coherence tomography angiography (OCTA) before and after Bevacizumab therapy in patients with macular edema associated with ischemic and non-ischemic retinal vein occlusion (RVO). 15 eyes with ischemic RVO and 20 with non-ischemic RVO were included. Each patient had 3 consecutive intravitreal injections of Bevacizumab every month. Best-corrected visual acuity (BCVA), central macular thickness (CMT) and retinal microvasculature were measured using OCTA before and one month after the third injection. The BCVA and FAZ area improved significantly after treatment in both ischemic and non-ischemic cases. Although, in ischemic group, FD, superficial and deep capillary VD decreased with no statistically significant change in the choriocapillaris flow. In the non-ischemic group, there was an increase in the FD, superficial parafoveal, perifoveal VD and choriocapillaris flow with insignificant increase in the DCP VD while the foveal VD showed a statistically significant decrease. In conclusion, anti-VEGF therapy improved the BCVA, retinal FD, VD in non-ischemic case but despite improvement in BCVA it reduced the VD in the ischemic cases