Difluprednate administered twice daily is at least as effective as prednisolone acetate administered 4 times daily for the treatment of ocular inflammation following cataract surgery, according to research published in the Journal of Cataract and Refractive Surgery.

For the prospective, multicenter, double-blind, randomized, noninferiority trial, the investigators compared the efficacy and safety of difluprednate 0.05% nanoemulsion twice daily with prednisolone acetate 1% plus phenylephrine hydrochloride 0.12% suspension (prednisolone) 4 times daily for the treatment of ocular inflammation following cataract surgery.

The study included 259 adult patients, with an average age of 64 years (range, 42-88), who underwent phacoemulsification at 4 private ophthalmological centers in Argentina. Patients were randomly assigned to initiate either difluprednate (n=135) or prednisolone (n=124) the day before surgery and continue for 28 days. The primary endpoint was central corneal thickness, and noninferiority was determined as a difference of corneal thickness between baseline and day 4 that did not differ by more than 17 μm between the treatment groups. All outcomes, including secondary endpoints and safety outcomes, were evaluated at baseline and days 1, 4, and 28 after surgery.


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The investigators found that the difference in corneal thickness at baseline and day 4 did not differ by more than 17 μm between the treatment groups (95% CI, -2.78μm to 14.84 μm; P =.52), indicating non-inferiority of difluprednate to prednisolone. They also found no statistically significant differences between the treatment groups in total anterior chamber clearance at any time during the study time (P >.05), corrected distance visual acuity (P =.45), endothelial cell count (P =.81), optical coherence tomography-central macular thickness (P =.87), or in intraocular pressure (IOP, P =.32).

A total of 225 patients completed the study. Overall, 9 patients were withdrawn from the study for safety reasons (difluprednate [n=5] and prednisolone [n=4]: IOP >30 mm Hg day 1, n=1 and n=2; corneal thickness >40% from basal values, n=1 and n=1; unable to measure corneal thickness due to edema, n=3 and n=1, respectively), and 25 patients were lost to follow up (n=12 and n=13, respectively). No serious ocular adverse events or systemic adverse events were reported for either treatment group.

“This study provides evidence about [twice daily] administration of difluprednate nanoemulsion in comparison to traditional treatment with prednisolone acetate [4 times daily],” according to the investigators. “Equivalent clinical outcomes can be reached with difluprednate with less dosing frequency, which may improve treatment compliance.”

Disclosure: This research was supported by Laboratorios POEN S.A.U. Multiple study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.  

Reference

Valvecchia G, Kaufer R, Ferroni C, et al. Difluprednate 0.05% twice a day vs prednisolone acetate 1% four times a day for cataract postsurgical inflammation treatment: a non-inferiority trial. J Cataract Refract Surg. Published online November 9, 2021. doi:10.1097/j.jcrs.0000000000000863