New research published in Clinical Ophthalmology evaluated the use of preservative-free corticosteroid 0.2% betamethasone sodium phosphate (SURF-201; Surface Ophthalmics, Inc) in treating ocular pain and inflammation following cataract surgery.
Give me some background first.
Standard treatments for ocular inflammation and pain—both common postop occurrences—typically include nonsteroidal anti-inflammatory drugs (NSAIDS) and corticosteroids, with the latter providing a wider anti-inflammatory response (not to mention costing less) than the former.
However, with this advantage also comes an increased risk for intraocular pressure (IOP) elevation and, due to a frequent dosing schedule, the possibility of decreased patient adherence and compliance.
And the issue at hand?
While a number of topical corticosteroids are FDA-approved and commonly used to treat postoperative pain and inflammation following ocular surgery, there is presently no such drug approved to specifically treat these symptoms following cataract surgery.
And that's where SURF-201 comes into play.
Talk about this drug.
SURF-201 is a novel, topical ophthalmic formulation of betamethasone sodium phosphate (BSP) 0.2% delivered in a buffered, isotonic, aqueous, non-preserved proprietary solution.
Currently in development by Surface Ophthalmics, the highly-concentrated betamethasone sterile eye drops is intended to provide fast and potent action in addressing postop pain and inflammation.
Now this study.
The multicenter, randomized, double-masked phase 2 study (NCT04324359) evaluated the ocular safety, tolerability, and efficacy of SURF-201 (against a vehicle) in 91 patients ages 18+ who underwent cataract surgery.
What were the dosings?
Patients were randomized 1:1 into two groups to receive either:
- SURF-201 administered twice daily (BID) in the study eye for 16 days (n = 45)
- Placebo administered BID in the study eye for 16 days (n = 46)
Participants began their regimen by instilling a dose of their assigned BID, 8 to 12 hours apart, on the day before surgery, then one dose instilled at least 1 hour before surgery, followed by one dose the evening after surgery, and BID for the remaining 14 days.
How was treatment efficacy measured?
The primary measurement was biomicroscopic examination of SURF-201-treated patients with an anterior chamber cell (ACC) grade of 0—compared to placebo-treated patients—at Day 15.
Secondary indicators included the number of participants with a pain score of 0 at each post-surgical visual analog scale (0 to 100 mm scale) assessment, measured at:
- Day 1
- Day 8
- Day 15
- Day 22
- Day 32
Out of the 91 initial participants, 82 patients were treated with their respective doses and included in the final data (SURF-201 group: N = 39; placebo group: N = 43).
In the SURF-201 group, a higher number of participants (56.4%) achieved an ACC score of 0 at Day 15 compared to placebo-treated participants (20.9%, p < 0.001).
And the pain score?
A higher proportion of SURF-201-treated patients were consistently pain-free throughout the study versus placebo-treated patients; however, investigators noted the difference was not statistically significant.
Any adverse effects?
Overall, SURF-201 was observed to be well-tolerated, with the majority of adverse events (AEs) as mild (30% of total) or moderate (25% of total) in severity.
A higher number of AEs occurred in SURF-201-treated patients (67.5%) vs placebo-treated (53.5%); however, the number of TEAEs were comparable 5% and 7%, respectively.
What about IOP?
Four study participants experienced clinically significant IOP increases at Day 1, Day 8, and Day 15 (SURF-treated) and Day 32 (vehicle-treated).
The two SURF-201-treated patients experienced the greatest increases in IOP at Day 1 (18 mmHg and 17 mmHg). Both were treated with IOP-lowering medication.
The study authors noted only one: the duration of the study period, which is shorter than previous studies that have evaluated corticosteroid use.
However, they determined that the findings would still hold true if a longer follow-up time had been given.
Per the authors, this study is the first to report on 0.2% BSP as a proprietary solution for treating pain and inflammation following cataract surgery.
They added that these findings are similar to prior research assessing the use of corticosteroids for postoperative surgical care.
SURF-201 was found to be an effective topical, preservative-free corticosteroid when dosed BID for treating postoperative inflammation and pain in cataract surgery patients.