Salvat Completes Phase 3 Clinical Trials of its New Ophthalmic Corticosteroid Nanoemulsion

Salvat has completed the phase 3 clinical trials in the US for its drug candidate for the treatment of ocular inflammation and pain after cataract surgery.

The clinical trials started in 2020 and include 400 adult patients who had recently undergone cataract surgery in 50 US hospitals. Results are expected to be available early in the second half of 2021 and the registration documentation will be submitted by the end of 2021.

After receiving authorization for its commercialization in the US and Europe, the drug will be produced in the Salvat USA Inc. plants in Miami, and Pharmaloop, S.L. in Alcalá de Henares (Madrid). Both companies are subsidiaries of Laboratorios Salvat S.A. Pending approval, the drug is expected to be marketed by the end of 2022. Authorization is also expected to be granted in Spain and in most European countries and other geographical areas by 2023, according to Salvat.

The first eye drug with nanoparticles

The drug candidate presents two main innovations, according to Salvat. First, the type of corticosteroid has not been used before in eye drops. Secondly, the nanoemulsion formulation (which is a nanometric-sized emulsion) increases tolerability, easily reaches the entire eye, prevents blurred vision, and is more comfortable for the patient.

In addition to developing the ocular corticosteroid, Salvat is working on four additional projects in ophthalmology—two in glaucoma and two in dry eye.