Novel topical dexamethasone formulation reduces inflammation, pain after cataract surgery

OCS-01, a topical dexamethasone 1.5% in a novel formulation, appears to be safe and effective in the management of inflammation and pain following cataract surgery, a study has found.

The phase II study randomized 153 adult patients who were scheduled to undergo unilateral uncomplicated cataract surgery to receive OCS-01 once daily (n=51), OCS-01 twice daily (n=51), or matching vehicle (n=51) for 15 days after the procedure.

Researchers checked for the absence of anterior chamber cells (ACC; cells=0) at day 15 and absence of pain (score of “0”) at day 4 postsurgery as the primary efficacy endpoints. They also assessed safety in terms of adverse events and changes in intraocular pressure.

Baseline characteristics were generally similar across the three treatment arms. The mean age ranged from 66 to 68 years, and the proportion of male patients ranged from 29 percent to 37 percent. Most of the patients in each arm were White (82–92 percent).

At day 15, the percentage of eyes with ACC grade 0 was greater in the OCS-01 once- and twice-daily arms than in the vehicle arm (51 percent and 66.7 percent vs 19.6 percent; p=0.0009 and p<0.0001, respectively).

OCS-01 also showed superiority over the vehicle in terms of the pain outcome. At day 4, the percentage of eyes without pain was 72.5 percent in the once-daily arm and 62.7 percent in the twice-daily arm vs 45.1 percent in the vehicle arm (p=0.005 and p=0.074, respectively).

Treatment was well tolerated. Treatment-emergent adverse events, including those ocular in nature, occurred more frequently in the vehicle arm than in the OCS-01 arms.