0.2% Betamethasone Sodium Phosphate: A Multicenter, Randomized, Double-Masked Study to Compare Its Ocular Safety, Tolerability, and Efficacy to Vehicle in Cataract Surgery Subjects

Abstract

Purpose

To compare the preservative-free corticosteroid 0.2% betamethasone sodium phosphate BID (SURF-201) to vehicle BID in patients undergoing routine cataract surgery.

Methods

Phase 2, multicenter, randomized (1:1 ratio), double-masked, vehicle-controlled, parallel-group study in patients scheduled for uncomplicated cataract surgery without the aid of a femtosecond laser. Subjects instilled topical medications for 16 days beginning the day before cataract surgery (Day −1), 1 dose administered at least 1 hour prior to cataract surgery (on Day 0) and 1 dose on the evening after cataract surgery, and then 2 doses administered each day through Day 15; patients were re-evaluated on Days 22 and 32 to ensure no rebound inflammation. Primary outcome was the difference in the proportion of subjects with anterior chamber cell (ACC) grade 0 between the two groups at Day 15. Secondary outcomes included pain scores and overall safety.

Results

There was a statistically significant difference (P=0.004) in the proportion of subjects in the SURF-201 treatment group with an ACC grade of 0 at Day 15 (n=22/39 [56.4%]) compared to subjects in the vehicle treatment group (n=9/43 [20.9%]). There was no statistically significant difference (P=0.528) in the proportion of subjects in the SURF-201 treatment group who had a visual analog scale pain score of 0 at Day 15 (n=35/38 [89.7%]) compared to subjects in the vehicle group (n=33/40 [82.5%]). A slightly higher incidence of adverse events occurred in subjects in the SURF-201 treatment group (n=27/40 [67.5%]) compared to the vehicle treatment group (n=23/43 [53.5%]).

Conclusion

SURF-201 is an effective topical, preservative-free corticosteroid when dosed BID for the treatment of postoperative inflammation and prevention of pain in a post-cataract population.

Keywords:

• cataract
• postoperative inflammation
• corticosteroid
• betamethasone sodium phosphate
• preservative-free

Data Sharing Statement

All reasonable requests for the data used in this study will be made available upon request to the corresponding author.

Acknowledgments

The abstract has been presented in part at AECOS 2021 Deer Valley, Utah. Michelle Dalton, ELS, Dalton & Associates, Inc., provided medical writing; this was funded by Surface Ophthalmics, Inc.

Disclosure

KH is an employee of Surface Ophthalmics; RLL and KH are members of the board of Surface Ophthalmics, Inc. RLL also reports personal fees from Alcon and Allegro during the conduct of the study. SG, HR, TW are paid investigators for Surface Ophthalmics, Inc. The authors report no other conflicts of interest in this work.

Additional information

Funding

Surface Ophthalmics, Inc. funded this study.