OCS-01 (Novel Topical Dexamethasone Formulation) in Inflammation and Pain Post Cataract Surgery: A Randomized, Double-Masked, Vehicle-Controlled Study.

Purpose: The goal of this study was to compare topical dexamethasone 1.5% in a novel formulation (OCS-01) once daily and BID versus vehicle for the treatment of inflammation and pain after cataract surgery.
Methods: This was a Phase II, double-masked, vehicle-controlled, randomized multicenter study. Adult patients with planned unilateral uncomplicated cataract surgery were randomized to receive OCS-01 once daily (n = 51), OCS-01 BID (n = 51), or matching vehicle (n = 51) for 15 days postsurgery. Primary end points were absence of anterior chamber cells (ACC; cells = 0) at Day 15 and absence of pain (score of "0") at postoperative Day 4. The Pearson χ ² test with a two-sided alpha = 0.1 was used to compare treatments. Safety was assessed in terms of adverse events and changes in intraocular pressure.
Findings: Treatment arms were generally similar in their baseline characteristics, with mean age ranging from 66 to 68 years, the proportion of male patients ranging from 29% to 37%, and 82% to 92% of each arm being White. On Day 15, a greater reduction in the percentage of eyes with ACC grade 0 was observed in the OCS-01 once daily (51%) and BID (66.7%) arms than in the vehicle arm (19.6%) (P = 0.0009 and P < 0.0001, respectively, using a Pearson χ ² test). On Day 4, the percentage of eyes with no pain was 72.5% (OCS-01 once daily), 62.7% (OCS-01 BID), and 45.1% (vehicle); statistical significance was reached for OCS-01 once daily (P = 0.005) and OCS-01 BID (P = 0.074) compared with vehicle. OCS-01 was well tolerated. A higher proportion of treatment-emergent adverse events, including ocular adverse events, were reported for the placebo group than for either OCS-01 group.
Implications: OCS-01 once daily and BID were more effective than vehicle and well tolerated in the treatment of inflammation and pain after cataract surgery.
Clinicaltrials: gov identifier: NCT04130802.
Competing Interests: Declaration of Interest Oculis were involved in the study design; the collection, analysis, and interpretation of data; in the writing of the report; and in the decision to submit the article for publication. The authors report no other conflicts of interest regarding the content of this article.
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