Study Finds Clobetasol Effective for Treating Post-Cataract Inflammation, Discomfort

Both Phase III trials for clobetasol propionate ophthalmic suspension 0.05% (Byqlovi, Harrow) demonstrate the drop’s ability to reduce ocular inflammation and pain and improve visual acuity. Its short treatment duration—twice-daily dosing for two weeks—may make it particularly advantageous for elderly patients, researchers suggest. Photo: Harrow. Click image to enlarge. In some patients, cataract surgery causes early postoperative inflammation, pain and delayed visual recovery, and current topical steroids can be burdensome, irritating or raise intraocular pressure (IOP). A novel nanoparticle aqueous suspension of clobetasol propionate (Byqlovi, Harrow, CPN 0.05%)—shown in animal studies to penetrate anterior ocular tissues and in a dose‑selection trial to reduce anterior chamber cell and flare without meaningful IOP rises—was advanced to two large randomized, double‑masked Phase III trials to confirm the efficacy and safety of a convenient twice‑daily, 14‑day postoperative regimen. In both trials, treated patients showed sustained reductions in anterior chamber inflammation and ocular pain, as well as accelerated visual recovery compared with placebo. The data from these Phase III trials, evaluated in a recent study published in Ophthalmology, supported the 2024 US FDA approval of Byqlovi for the treatment of postoperative inflammation and pain following ocular surgery.The two multicenter, randomized, double‑masked Phase III trials (CPN‑301 and CPN‑302) enrolled adults after uncomplicated cataract surgery who had an anterior chamber cell count ≥10 and IOP ≤30mm Hg on postoperative day one. The cohort comprised 748 participants who were randomized to receive CBN 0.05% (n=366) or placebo (n=382). Drops were instilled once per day for 14 days into the operated eye. Demographic and baseline characteristics were well-balanced between the two groups. CPN 0.05% met the primary endpoints, producing rapid, sustained resolution of inflammation and elimination of ocular pain, demonstrating superiority over the placebo. Specifically, on postoperative day 15, 58.2% of participants treated with CPN 0.05% had an anterior chamber cell count of zero vs. 17.3% with placebo, and a larger percentage reported being pain-free (88.5% vs. 45.8% for placebo). Visual acuity improved faster with CPN 0.05% by postoperative day four, and there was no rebound in efficacy at postoperative day 22 after treatment was stopped for one week. Moreover, significantly fewer participants on CPN 0.05% required rescue medication compared with placebo.Importantly, no meaningful safety signals were observed in the study population. The data showed that CPN 0.05% was well-tolerated with a safety profile similar to placebo, and no meaningful IOP increases or corneal endothelial cell changes were observed. The researchers explained in their paper that “the short treatment duration with CPN 0.05% may in part explain the lower rate of increased IOP because IOP elevation secondary to corticosteroids is more likely to occur with longer treatment duration.”The favorable efficacy and safety profiles of CPN 0.05%, as well as its ability to provide rapid improvement of visual acuity, make this medication “a comfortable, convenient, twice daily and short-course therapy without the need for tapering,” the authors noted, adding that these “are important advantages over other topical ocular corticosteroid treatments, especially for frail elderly patients.”In their paper, the authors highlight a few limitations of these trials. This includes the absence of an active corticosteroid comparator—both trials used placebo with rescue permitted—so head‑to‑head efficacy and tolerability vs. established agents remain unknown. The studies also used a short follow‑up duration (up to postoperative day 22), which limits the detection of less common, later complications (e.g., delayed cystoid macular edema, posterior capsular opacification). However, a corneal endothelial substudy extended to post-op day 85 reported no late issues. Finally, patients with glaucoma or prior steroid‑related IOP elevation were excluded, so safety in those at‑risk groups will require further testing.Based on this trial data, the authors concluded that CPN 0.05% administered once daily for 14 days “rapidly reduces ocular inflammation and pain and improves visual acuity after cataract surgery, and it is safe and well tolerated.” They added that the “combination of anti-inflammatory efficacy and a convenient short treatment duration (twice-daily dosing for 14 days) may offer practical advantages in the postoperative setting.”Click here for the source. Korenfeld MS, Levenson J, Sadri E, et al. Clobetasol propionate ophthalmic suspension (BYQLOVI) to treat ocular inflammation and pain after uncomplicated cataract surgery. Ophthalmology. May 9, 2026. [Epub ahead of print].  This article was developed by the editorial staff in conjunction with experts in the field. In the process, AI may have been among the editorial tools used to meet the goals of human editors, who approved all content.