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Salvat heads to regulators with phase 3 data on ocular steroid

Salvat is gearing up to launch an ocular corticosteroid treatment for inflammation and pain in cataract surgery patients after finishing phase 3 trials and starting the approval process in the U.S. and Europe.

The studies tested clobetasol, a steroid that is already used to reduce the swelling and itching associated with skin conditions such as eczema. Salvat, a Spanish pharma company, applied its nanoemulsion drug delivery technology to the molecule to create a candidate suitable for ocular use. By dissolving the active ingredient in nanodroplets, Salvat aimed to improve adherence, penetration and comfort.

Salvat now has phase 3 data it thinks will support regulatory approvals and position it to bring the product to market by the middle of next year. The studies enrolled 426 participants to apply the drug or placebo four times a day for 14 days after undergoing cataract surgery.

“Both studies achieved their objective of demonstrating the efficacy and safety of clobetasol by finding significant differences against the placebo not only in the main variable of the studies, which was the total absence of inflammation after the first 7 days of treatment, but also in the vast majority of ocular parameters evaluated,” Salvat wrote in a statement. lists the primary endpoint of the phase 3 trials as the proportion of participants with an anterior chamber cell grade of “0” (absence of cells) compared to placebo. The secondary endpoints looked at pain, inflammation, vision and other measures.

Salvat plans to provide the treatment in sterile single-dose vials in the belief the format is more convenient and optimizes compliance by enabling the administration of the exact dose. According to the company, the product will be the first unit dose therapy on the market indicated for the treatment of inflammation and pain after ocular surgery.