Difluprednate versus prednisolone acetate for inflammation following cataract surgery in pediatric patients: a randomized safety and efficacy study

Abstract

PurposeTo evaluate safety and efficacy of difluprednate 0.05% ophthalmic emulsion for treatment of postoperative inflammation after cataract surgery in pediatric patients.MethodsThis was a phase 3B, multicentre, randomized, double-masked, active-controlled study of patients aged 0–3 years who underwent uncomplicated cataract surgery in one eye, with/without intraocular lens implantation. Patients were randomized to receive difluprednate 0.05% four times daily or prednisolone acetate 1% for 14 days post surgery, followed by tapering for 14 days. Safety included evaluation of adverse events. Primary efficacy was the proportion of patients with an anterior cell grade of 0 (no cells) at day 14; secondary efficacy was a global inflammation score.ResultsForty patients were randomized to each treatment group. Adverse drug reactions included corneal oedema (difluprednate 0.5%, n=1; prednisolone acetate 1%, n=0) and increased intraocular pressure or ocular hypertension (n=2/group). Mean intraocular pressure values during treatment were 2–3 mm Hg higher with difluprednate 0.05% compared with prednisolone acetate 1% mean values were similar between groups by the first week after treatment cessation. At 2 weeks post surgery, the incidence of complete clearing of anterior chamber cells was similar between groups (difluprednate 0.05%, n=30 (78.9%); prednisolone acetate 1%, n=31 (77.5%). Compared with prednisolone acetate 1%, approximately twice as many difluprednate 0.05%-treated patients had a global inflammation assessment score indicating no inflammation on day 1 (n=12 (30.8%) vs n=7 (17.5%) and day 8 (n=18 (48.7%) vs n=10 (25.0%).ConclusionsDifluprednate 0.05% four times daily showed safety and efficacy profiles similar to prednisolone acetate 1% four times daily in children 0–3 years undergoing cataract surgery.

Neovascular age‐related macular degeneration is associated with cataract surgery

“…As for the theory of cataract surgery-related inflammation, intraocular inflammation is common after cataract surgery. The inflammatory response occurs when the bloodaqueous barrier is compromised, thus increasing vascular permeability changes associated with inflammation and oedema (Modi et al 2014;Wilson et al 2016). Inflammation induced by cataract surgery may exacerbate the rate of AMD progression (Donoso et al 2006).…”

A retrospective analysis of intraocular pressure changes after cataract surgery with the use of prednisolone acetate 1% versus difluprednate 0.05%

“…A more recent study of post-cataract surgery pediatric patients (0–3 years old) compared DFBA and PA and found similar safety and efficacy profiles between the two corticosteroids 31. Patients received a regimen of either DFBA or PA QID for 14 days, followed by a 14 day taper.…”

<p>Difluprednate 0.05% versus Prednisolone Acetate Post-Phacoemulsification for Inflammation and Pain: An Efficacy and Safety Clinical Trial</p>

“…6,7 Several studies have demonstrated that topical steroids are safe and effective in reducing ocular inflammation when administered during surgery and throughout the immediate 4 weeks following cataract extraction. 8,9 Difluprednate ophthalmic emulsion is a topical ocular corticosteroid that has been approved by the US Food and Drug Administration (FDA) since 2008 as treatment for the inflammation and pain associated with ocular surgery. 4,7,[9][10][11] However, in Mexico and Latin America, it is not currently commercially available.…”

“…8,9 Difluprednate ophthalmic emulsion is a topical ocular corticosteroid that has been approved by the US Food and Drug Administration (FDA) since 2008 as treatment for the inflammation and pain associated with ocular surgery. 4,7,[9][10][11] However, in Mexico and Latin America, it is not currently commercially available. Difluprednate is an ophthalmic steroid with high glucocorticoid receptorbinding affinity and high tissue penetration, therefore it is considered more potent than other topically applied steroids.…”