Clobetasol Propionate Ophthalmic Suspension (BYQLOVI®) to Treat Ocular Inflammation and Pain after Uncomplicated Cataract Surgery

OBJECTIVE: To evaluate the efficacy and safety of clobetasol propionate ophthalmic suspension 0.05% (CPN 0.05%) for the treatment of ocular inflammation and pain after cataract surgery. DESIGN: Two multicenter, randomized, double-masked, placebo-controlled Phase 3 trials (CPN-301 and CPN-302), identical in design except for a corneal endothelial cell (EC) safety sub-study in CPN-302. PARTICIPANTS: Patients who had uncomplicated cataract surgery. METHODS: Post surgery, participants were randomized to CPN 0.05% or Placebo (1:1) instilled 1 drop twice daily (BID) for 14 days into the operated eye. MAIN OUTCOME MEASURES: Efficacy: (i) the percentage of participants with Anterior Chamber Cell (ACC) count = 0 at post-operative day (POD) 8, maintained through POD 15, (ii) the percentage of participants with Ocular Pain (OP) grade = 0 at POD 4, maintained through POD 15, (iii) inflammation, OP grade and visual acuity at POD 4, 8, 15 and 22. SAFETY: adverse event reports, ophthalmoscopy, intraocular pressure (IOP) and EC assessments. RESULTS: Data from the two studies were pooled. 748 participants were randomized to receive CPN 0.05% (N=366) or Placebo (N=382). The demographic and baseline characteristics were well balanced between the two groups and were representative of cataract surgery patients. CPN 0.05% met the primary endpoints, producing rapid and sustained clearance of inflammation and absence of OP that was statistically significantly greater than Placebo. At POD 15, 58.2% of CPN 0.05% participants and 17.3% of Placebo participants had an ACC Count = 0 (p<0.001), and 88.5% of CPN 0.05% participants and 45.8% of Placebo participants had an OP grade = 0 (p<0.001). By POD 4, visual acuity had improved more rapidly on CPN 0.05% than on Placebo (p<0.001). There was no rebound of the efficacy parameters on POD 22 after CPN 0.05% was stopped for 1 week. More participants on Placebo than on CPN 0.05% required rescue medications (p<0.001). CPN 0.05% was well-tolerated with a safety profile similar to Placebo. There were no meaningful IOP increases or corneal EC changes in CPN 0.05%-treated participants. CONCLUSION: CPN 0.05% administered BID for 14 days was safe and rapidly improved ocular pain, inflammation and visual acuity after cataract surgery.