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

• Published in: Clinical ophthalmology (Auckland, N.Z.) Vol. 17; pp. 2219 - 2230
• Main Authors: Hosseini, Kamran, Gollamudi, Subba, Reiser, Harvey, Walters, Tom, Lindstrom, Richard L
• Format: Journal Article
• Language: English
• Published: New Zealand Dove Medical Press Limited 01.01.2023; Dove; Dove Medical Press
• Subjects: Betamethasone; betamethasone sodium phosphate; Cataract; Clinical Trial Report; corticosteroid; Corticosteroids; Difluprednate; Inflammation; Medical research; Medicine, Experimental; Patient compliance; Phosphates; postoperative inflammation; preservative-free; Surfing; Surgery; corticosteroid; preservative-free; betamethasone sodium phosphate; cataract; postoperative inflammation
• ISSN: 1177-5483; 1177-5467; 1177-5483
• DOI: 10.2147/OPTH.S419857

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