Novel dexamethasone formulation shows efficacy and safety with once-daily use

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Eric D. Donnenfeld, a consultant to Oculis reported for Ophthalmology Times on the results of a phase 2 trial: dexamethasone cyclodextrin nanoparticle ophthalmic suspension 1.5% mg/mL (OCS-01, Oculis), a novel topical formulation of dexamethasone, has the potential to become the first once-daily and preservative-free topical corticosteroid for treating pain and inflammation after ocular surgery.

Donnenfeld reported results from the SKYGGN study that randomly selected 153 patients 1:1:1 to treatment with OCS-01 once daily, OCS-01 twice daily, or vehicle for 14 days. The study met its primary endpoints analyzing absence of anterior chamber cells at postop day 15 and absence of ocular pain at postop day 4. There were no efficacy differences between the two OCS-01 dosing regimens and both were safe and well-tolerated.

“Inflammation and pain remain expected consequences of ocular surgery. Although available topical steroids are effective for treating these sequelae, potency and compliance with products that need to be used several times a day are major issues,” said Donnenfeld, a SKYGGN investigator who is clinical professor of ophthalmology, New York University Langone Medical Center, New York, and Founding Partner, Ophthalmic Consultants of Long Island and Connecticut, Garden City, NY. “Using a novel and proprietary nanoparticle formulation, OCS-01 was developed to deliver a potent anti-inflammatory effect and excellent safety profile with once-a-day dosing.”

Donnenfeld noted that the concentration of dexamethasone in OCS-01 is 15-fold greater than that found in commercially available topical dexamethasone suspension. In addition, the novel vehicle used for OCS-01 increases ocular surface residency time to hours compared with minutes using conventional dexamethasone 0.1% suspension. Furthermore, the proprietary nanoparticle technology enhances penetration of the active ingredient. As another benefit, the formulation is preservative-free.

One patient in the vehicle group and one patient treated with OCS-01 twice daily withdrew from the study because of an adverse event. However, there were no significant ocular or systemic adverse events. Importantly, IOP ≥30 mm Hg was not observed in any patients at any follow-up visits nor did any patient have a ≥10 mm Hg increase from baseline IOP.

“The overall adverse event rate was higher in the vehicle group than in the OCS-01 groups, probably because the adverse events were procedure-related rather than treatment-related,” Donnenfeld said.

Donnenfeld noted that the potent activity, safety, and tolerability of OCS-01 observed in SKYGGN are consistent with results of another phase 2 trial investigating the novel steroid formulation as a treatment for diabetic macular edema. The latter study enrolled 144 patients and found a statistically significantly greater decrease in central macular thickness in patients treated with OCS-01 compared with vehicle-treated controls. There were no significant ocular adverse events in the OCS-01 group.

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