Benefit of Clobetasol Propionate Post-Cataract Surgery, With Jeffrey Levenson, MD

Twice-daily clobetasol propionate ophthalmic suspension 0.05% for 14 days achieved rapid and sustained reduction of ocular inflammation and pain after cataract surgery, compared with placebo, in new results from two pivotal Phase 3 trials.

Presented at the 2025 American Society of Cataract and Refractive Surgery (ASCRS) Annual Meeting, clobetasol propionate ophthalmic suspension revealed quicker and greater visual acuity (VA) improvement and a similar adverse event profile to placebo, suggesting its effectiveness following ocular surgery.

“It offers the potential for a brief course of potent anti-inflammatory therapy that’s easy to comply with, just twice a day, and no need for a taper,” presenting investigator Jeffrey H. Levenson, MD, founding director and managing partner of Levenson Eye Associates, told HCPLive. “It’s patient and doctor-friendly and might enable fewer post-operative visits, offering potential benefits over the modalities we now use.”

The US Food and Drug Administration (FDA) approved clobetasol propionate ophthalmic suspension 0.05% for post-operative inflammation and pain following ocular surgery in March 2024, marking the first new steroid approved for eye care in 15 years.

Dual multicenter, randomized, double-masked, placebo-controlled, parallel-group studies randomized patients undergoing routine unilateral uncomplicated cataract surgery to receive clobetasol propionate ophthalmic suspension (n = 366) or placebo (n = 382) for 14 days after surgery. The primary efficacy endpoint included the proportion of patients with an anterior chamber cell (ACC) count of 0 at Days 4 to 15, with secondary endpoints including ocular pain grade at each follow-up visit.

More patients treated with clobetasol propionate ophthalmic suspension achieved an ACC of 0 at Days 8 to 15, compared with placebo (26.5% vs. 6.8%; P <.001), as well as a significantly higher proportion with ocular pain grade of 0 at Days 4 to 15 (71.6% vs. 27.7%; P <.001).

Those treated with clobetasol propionate ophthalmic suspension also experienced a more rapid rate of improvement and greater magnitude of improvement in the BCVA by Day 4, while significantly fewer required rescue medication (6.3% vs. 44.8%; P <.001). Further data showed similar increases in intraocular pressure (IOP), with only 1.4% of the clobetasol propionate ophthalmic suspension seeing increases.

Clobetasol propionate ophthalmic suspension was well-tolerated with few adverse events and similar corneal endothelial cell count (ECC) changes versus placebo.

“Patients don't mention their drops, other than to say that they're doing well and they're seeing well, and they're pleased with their surgical outcomes,” Levenson told HCPLive. “The best comment from a patient with regards to a procedure is nothing but pleasure and seeing better.”

Levenson reports no relevant disclosures.

References

1. Levenson JH, Korenfeld MS, Silverstein SM, et al. Pivotal Phase 3 Studies of Clobetasol Propionate Ophthalmic Suspension 0.05% for Post-Cataract Surgery Inflammation and Pain. Presented at: 2025 American Society of Cataract and Refractive Surgery (ASCRS) Annual Meeting. April 25-28, 2025. Los Angeles, CA.

2. Formosa Pharmaceuticals and AIMMAX Therapeutics receive FDA approval for Clobetasol propionate ophthalmic suspension 0.05%, for the treatment of post-operative inflammation and pain following ocular surgery. March 4, 2024. Accessed April 25, 2025. https://www.prnewswire.com/news-releases/formosa-pharmaceuticals-and-aimmax-therapeutics-receive-fda-approval-for-clobetasol-propionate-ophthalmic-suspension-0-05-for-the-treatment-of-post-operative-inflammation-and-pain-following-ocular-surgery-302079089.html.