OSD is prevalent among medically treated patients with glaucoma. The severity of OSD symptoms is positively correlated to the number of IOP-lowering medications used.
Single-use dual blade goniotomy plus phacoemulsification resulted in a significant and sustained reduction in IOP and a decrease in glaucoma medications after 6 months of follow-up.
IntroductionLittle is known of the ocular distribution characteristics of currently branded non-steroidal anti-inflammatory drugs (NSAIDs) in the United States. This study was designed to predict the ocular bioavailability characteristics in humans using Dutch Belted rabbits as a surrogate. Commercially available, topically-applied NSAIDs containing bromfenac or nepafenac/amfenac were evaluated.Methods126 healthy adult Dutch Belted rabbits were randomly assigned to three treatment cohorts (BromSite® twice daily [BID] in the right eye, BromSite® once daily [QD] in the right eye, Prolensa® QD in the right eye and Ilevro™ QD in the left eye) and 7 post-dosing time points (0.5, 1, 2, 4, 8, 12, 24 h after final instillation). The study eyes received 40 µL of the assigned drug for a consecutive 9 days. Samples of aqueous humor, iris-ciliary body, choroid, sclera, and retina were harvested from the study eyes at the assigned time point after the last dose on the 9th day. NSAID content in ocular tissues was analyzed using high-performance liquid chromatography (HPLC), and area under the curve (AUC0.5–24h), maximum concentration (Cmax), and time to maximum concentration (Tmax) were determined.ResultsPeak NSAID concentrations were reached within 1–3 h in the anterior segment and within 1–3 h in the posterior segment after last dose. Throughout the ocular tissues, both AUC and Cmax for BromSite® (BID and QD) were consistently higher than respective NSAID concentrations of Prolensa® QD and Ilevro® QD. When comparing BromSite® BID to QD, the BID regimen produced generally higher but statistically similar bromfenac concentrations throughout the ocular tissues except in the aqueous humor and iris-ciliary body, where the AUC BID was statistically significantly higher with BromSite® BID.ConclusionAs a surrogate to human ocular bioavailability, BromSite® demonstrated significantly greater NSAID compared to Prolensa® QD and Ilevro® QD. The DuraSite® component of BromSite® appears to enhance ocular penetration throughout both anterior and posterior tissues.FundingSun Pharmaceutical Industries Ltd.
PurposeThe purpose of this study was to compare the aqueous humor concentrations of bimatoprost acid after topical instillation in rabbits of bimatoprost ophthalmic solution 0.01% and bimatoprost ophthalmic solution 0.03%, two commercially available intraocular pressure-lowering medications.MethodsMale Dutch Belted rabbits were divided into two treatment groups (four rabbits/eight eyes per group): bimatoprost 0.01% and bimatoprost 0.03%. Thirty microliters (μL) of study medication was to pically instilled into both eyes of each animal. Thirty minutes and 90 minutes after instillation, aqueous humor samples were collected. These samples were analyzed by reverse-phase high-performance liquid chromatography for bimatoprost acid concentration.ResultsFollowing a single topical ocular instillation, the bimatoprost 0.01% formulation had a lower mean aqueous humor concentration of bimatoprost acid than the bimatoprost 0.03% formulation at both 30 minutes (11.5 ± 2.1 ng/mL versus 37.8 ± 28.8 ng/mL; P = 0.17) and 90 minutes (20.8 ± 5.7 ng/mL versus 45.8 ± 14.3 ng/mL; P = 0.03) after topical instillation.ConclusionsTopical ocular instillation of bimatoprost 0.01% produced significantly lower bimatoprost acid concentration in the aqueous humor of rabbits than bimatoprost 0.03%, despite the 4-fold increase of benzalkonium chloride contained in bimatoprost 0.01%.
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