Bimatoprost SR for Glaucoma Therapy Implanted at the Slit-Lamp in a Real-World Setting.

Purpose: To characterize clinical outcomes following a single administration of bimatoprost SR in eyes with glaucoma in a real-world setting implanted at the slit-lamp. Setting: Tertiary care Glaucoma practice, Glaucoma Associates of Texas, Dallas, Texas. Design: Retrospective interventional case series. Methods: Data were analyzed from consecutive patients receiving a single bimatoprost SR implant from the time of its approval to the time of data collection. All eyes were implanted at the slit-lamp. Eyes with less than 1 month of follow-up were excluded. The primary outcome was median time to next intraocular pressure (IOP)-lowering intervention. Mean IOP and medication use, and changes from baseline, were also assessed through 12 months of follow-up. Results: Overall 129 eyes of 81 patients were analyzed. Following bimatoprost SR administration (replacing a topical prostaglandin analogue [PGA] in most eyes), the median survival time without any further IOP-lowering interventions was between 6-9 months. Mean IOP remained unchanged from baseline at month 1 (consistent with switch from topical to intracameral PGA therapy) and began to rise at month 3. At month 12, 40.5% of eyes (52 eyes) remained intervention-free, mean medication reduction was 0.5 medications per eye, and 27.8% of eyes (36 eyes) were medication-free. Adverse events were uncommon and most were transient and resolved with or without intervention. Conclusion: This real-world analysis of bimatoprost SR use for glaucoma therapy complements Phase 3 study findings and demonstrates that the implant can safely provide medication reduction through 6 months in most eyes and through 12 months in almost 40% of eyes.

Intraocular Pressure and Eyedrop Usage Reduction with Intracameral Bimatoprost Implant.

Purpose: Sustained intraocular drug delivery devices are being developed to lower intraocular pressure (IOP) and improve adherence in patients with glaucoma. The purpose of this study was to assess the IOP and eyedrop usage reduction effects of intracameral bimatoprost implants. Methods: We retrospectively reviewed the records of 46 eyes from 38 patients who received an intracameral implant containing 10 µg of bimatoprost as a replacement or addition to their existing eyedrop regimen and investigated IOP, eyedrop usage, and adverse effects. Results: Patients were followed for an average of 274 ± 104 (mean ± standard deviation) days after implant. Mean reduction in IOP (mmHg) at 3 months ±30 days, 6 months ±60 days, and 12 months ±90 days postoperation compared to baseline was 1.26 ± 2.53 (P = 0.002), 0.93 ± 4.71 (P = 0.098), and 1.35 ± 5.24 (P = 0.053), respectively. Reduction in eyedrops at 3 months ±30 days, 6 months ±60 days, and 12 months ±90 days postoperation compared to baseline were 0.62 ± 0.49 (P < 0.001), 0.55 ± 0.73 (P < 0.001), and 0.51 ± 0.71 (P < 0.001), respectively. Fifteen eyes (32.6%) experienced implant failure, defined as either restarting IOP-lowering eyedrops or undergoing surgical intervention, at an average of 260 ± 122 days after implant. Conclusions: While some patients eventually experienced implant failure, intracameral bimatoprost implants may result in fewer adverse reactions and successfully lower IOP and eyedrop burden over a longer period than previously reported.

Intracameral sustained release bimatoprost implants (Durysta).

BACKGROUND: Sustained release drug delivery has the potential to change glaucoma care by decreasing the challenge of medication adherence. Many approaches are in development, but this review focuses on Durysta (Allergan plc, Dublin, Ireland), the only FDA-approved sustained release intracameral treatment available at this time. KEY FINDINGS: Durysta is a bimatoprost sustained release (BimSR) intracameral implant. Clinical trials have demonstrated that BimSR implants can provide comparable levels of intraocular pressure (IOP) control as topical eyedrops. BimSR has advantages such as decreasing concerns regarding drop adherence, reducing ocular surface and periocular side effects from topical drops, and decreased daily treatment burden for patients. In addition, studies have shown continued IOP lowering in some eyes during extended follow-up periods when all of the BimSR medication has already been delivered. Hypothesized mechanisms to explain this finding include increased matrix metalloproteinase expression that causes extracellular matrix reorganization to permit greater aqueous outflow, as well as decreased episcleral venous pressure. The major safety concern at this time for Durysta and future intracameral implants is corneal endothelial cell loss, which was worse with repeat BimSR administration compared to single dosing. Several studies are underway to investigate mechanisms of action and to better understand safe and effective dosing of medications in this class.