Twice-daily betamethasone eye drops reduce inflammation, pain after cataract surgery
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Key takeaways:
- A novel preservative-free betamethasone eye drop formulation showed efficacy in preventing inflammation and pain after cataract surgery.
- The formulation allows for reduced twice-daily administration.
SURF-201, a novel preservative-free topical formulation of betamethasone sodium phosphate, showed efficacy in preventing inflammation and pain in a post-cataract population.
In these eye drops, betamethasone sodium phosphate is present in a higher 0.2% concentration than in other formulations, allowing for reduced frequency of dosing, twice per day. The vehicle used contains chondroitin sulfate and was previously demonstrated to have beneficial properties on cell membrane stabilization and reduction of corneal edema.
Image: Adobe Stock
In the phase 2 study, 83 subjects were randomly assigned 1:1 to receive SURF-201 (Surface Ophthalmics) or vehicle from day 1 to day 15 after cataract surgery. Evaluations of efficacy included biomicroscopic examinations for anterior chamber cells and flare and compilation of a pain assessment diary based on the visual analog scale of ocular pain.
A higher proportion of subjects in the SURF-201 group (56.4%) had an anterior chamber cell score of 0 at day 15 compared with subjects in the vehicle group (20.9%) (P < 001). The proportion of patients who remained pain-free throughout the study period was consistently higher in the SURF-201 group than in the vehicle group, although the difference was not statistically significant.
The study drug was well tolerated. The majority of adverse events were mild to moderate, and the incidence of treatment-emergent adverse events was similar in the two groups.
Two subjects in the SURF-201 group experienced an IOP increase at day 1, to 18 mm Hg and 17 mm Hg, respectively, and were treated with IOP-lowering medications.
“It is well accepted that older patients have difficulty instilling topical medications properly, and the reduced dosing schedule (twice daily) of our formulation may be able to help alleviate those obstacles to proper dosing,” the authors wrote.
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