Fluorometholone ophthalmic suspension is indicated for the treatment of corticosteroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe. The treatment is administered as 1 drop into the conjunctival sac 2 to 4 times daily. During the first 24 to 48 hours, the dosing frequency may be increased to 1 application every 4 hours. 

Patients should be reevaluated if signs/symptoms fail to improve after 2 days. Intraocular pressure should be monitored if the product is used for 10 days or longer.

Amneal’s Fluorometholone Ophthalmic Suspension 0.1% is supplied as a sterile, white to off-white homogenous suspension in 10mL bottles containing 5mL of product and in 15mL bottles containing 10mL of product.

The product consists of the corticosteroid clobetasol propionate and was developed using proprietary technology that reduces the particle size of the active ingredient. The approval was based on data from 2 randomized, double-masked, vehicle-controlled phase 3 trials (ClinicalTrials.gov Identifier: Study 1 [NCT04739709], Study 2 [NCT04810962]), which evaluated the efficacy and safety of Clobetasol Propionate Ophthalmic Suspension 0.05% in patients with at least 10 cells in the anterior chamber after cataract surgery. 

Study participants were randomly assigned to receive either 1 drop of Clobetasol Propionate Ophthalmic Suspension 0.05% (n=366) or vehicle (n=382) twice daily for 14 days starting on the day after surgery. The coprimary efficacy endpoints were complete resolution of inflammation (proportion of patients with an anterior chamber cell [ACC] count of 0 at postoperative day [POD] 8 maintained through POD15 without rescue medication), and complete resolution of pain (proportion of patients with ocular pain grade of 0 at POD4 maintained through POD15).

In the intent-to-treat analysis, both coprimary efficacy endpoints were statistically significantly better in Clobetasol Propionate Ophthalmic Suspension 0.05%-treated patients compared with vehicle-treated patients (P <.01).

Study 1 (N=366) results included the following for the clobetasol and placebo arms, respectively:

• ACC count of 0 at POD8: 32.6% vs 11.7%.
• ACC count of 0 at POD15: 58.6% vs 15.7%.
• Ocular pain grade of 0 at POD4: 77.3% vs 43.7%.
• Ocular pain grade of 0 at POD8: 82.3% vs 42.6%.
• Ocular pain grade of 0 at POD15: 90.6% vs 42.1%.

Study 2 (N=382) results included the following for the clobetasol and placebo arms, respectively:

• ACC count of 0 at POD8: 29.7% vs 13.0%.
• ACC count of 0 at POD15: 57.8% vs 18.9%.
• Ocular pain grade of 0 at POD4: 85.4% vs 51.4%.
• Ocular pain grade of 0 at POD8: 87.0% vs 46.5%.
• Ocular pain grade of 0 at POD15: 86.5% vs 49.7%.

As for safety, ocular adverse reactions reported with Clobetasol Propionate Ophthalmic Suspension 0.05% included eye inflammation (2%), corneal edema (2%), anterior chamber inflammation (2%), cystoid macular edema (2%), intraocular pressure elevation (1%), photophobia (1%) and vitreous detachment (1%). According to the prescribing information, many of these reactions may have been the consequence of the surgical procedure.

Clobetasol Propionate Ophthalmic Suspension 0.05% is supplied in a multidose 5mL bottle and is expected to be available in the summer of 2024.