Difluprednate 0.05% Versus Prednisolone Acetate 1% for Endogenous Anterior Uveitis: A Phase III, Multicenter, Randomized Study

Abstract

PURPOSE. Endogenous anterior uveitis (AU), when untreated, may lead to vision loss. This study compared the safety and efficacy of difluprednate versus prednisolone acetate for the treatment of this condition.METHODS. This phase III, double-masked, noninferiority study randomized patients with mild to moderate endogenous AU to receive difluprednate 0.05% (n ¼ 56) four times daily, alternating with vehicle four times daily, or prednisolone acetate 1% (n ¼ 54) eight times daily. The 14-day treatment period was followed by a 14-day dose-tapering period and a 14-day observation period. The primary efficacy end point was change in anterior chamber cell grade (range, 0 for 1 cell to 4 for >50 cells) from baseline to day 14.RESULTS. At day 14, the mean change in anterior chamber cell grade with difluprednate was noninferior to that with prednisolone acetate (À2.2 vs. À2.0, P ¼ 0.16). The proportions of difluprednate-treated patients versus prednisolone acetate-treated patients demonstrating complete clearing of anterior chamber cells at day 3 were 13.0% vs. 2.1% (P ¼ 0.046) and at day 21 were 73.9% vs. 63.8% (P ¼ 0.013). A significant between-group difference in the mean IOP increase was seen at day 3 (2.5 mm Hg for difluprednate-treated patients and 0.1 mm Hg for prednisolone acetate-treated patients, P ¼ 0.0013) but not at other time points. The mean IOP values in both groups remained less than 21 mm Hg throughout the study.CONCLUSIONS. Difluprednate 0.05% four times daily is well tolerated and is noninferior to prednisolone acetate 1% eight times daily for the treatment of endogenous AU. (ClinicalTrials.gov number, NCT01201798.)

To Study the Efficacy of Difluprednate Ophthalmic Emulsion and Prednisolone Acetate Ophthalmic Suspension on Post- operative Inflammation in Cataract Surgery

“…Sheppard JD, in his study concluded that difluprednate 0.05% four times daily is equivalent to prednisolone acetate 1% eight times daily in management of intra ocular inflammation in endogenous anterior uveitis [17].…”

Corticosteroids and Anti-Complement Therapy in Retinal Diseases

“…The 0.5% difluprednate ophthalmic emulsion (Durezol, Alcon Laboratories, Fort Worth, TX) has high glucocorticoid receptor affinity, tissue penetration, and bioavailability ). Studies in patients with endogenous anterior uveitis have shown non-inferiority of difluprednate 0.05% dosed four times daily compared to prednisolone acetate 1% dosed eight times daily for 14 days Sheppard et al 2014). Clinically important IOP elevations were observed in 8.9-12% of eyes that received difluprednate compared to 3.7-5% of eyes that received prednisolone acetate 1%.…”

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

“…10,11 Difluprednate ophthalmic emulsion 0.05% is a topical ocular corticosteroid that has been approved since 2008 for use in adults, initially for treatment of inflammation and pain associated with ocular surgery, and subsequently for treatment of endogenous anterior uveitis. 12,13 Recent studies in adults have shown that difluprednate treatment is associated with rapid resolution of both inflammation and pain associated with ocular surgery. 9 Phase 3 studies in adults have shown that difluprednate 0.05% four times daily is well tolerated and noninferior to prednisolone acetate 1% eight times daily for treatment of endogenous anterior uveitis.…”

“…9 Phase 3 studies in adults have shown that difluprednate 0.05% four times daily is well tolerated and noninferior to prednisolone acetate 1% eight times daily for treatment of endogenous anterior uveitis. 12,14 Children have a greater propensity for postoperative inflammation than adults. 3,8,15 The safety of topical difluprednate after ocular surgery in children has not been previously established.…”