Salvat completes Phase III clinical trials of its new ophthalmic corticosteroid nanoemulsion

The aim of these trials, which began in 2020, is to prove the efficacy of this innovative drug in treating ocular inflammation and pain after cataract surgery. For the first time in the world, this new product will use nanoparticles applied to the eye in order to help the drug’s absorption and application.

The trials have been carried out despite the pandemic. They represent a strategic project for Salvat, since, with an investment of more than 12 million dollars, they seek to reinforce the company’s position in the ophthalmology field worldwide. According to Alberto Bueno, Salvat’s CEO, “these trials also prove Laboratorios Salvat’s commitment to R&D and growth in the North American market”, where 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.

The clinical trials were agreed with the Food and Drug Administration (FDA), started in 2020 and have involved 400 adult patients who had recently undergone cataract surgery coming from 50 US hospitals, despite the difficulties resulting from the COVID-19 pandemic.

Once the patient recruitment phase has been completed, 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 USA and Europe, the drug will be produced in the Salvat USA Inc. plants in Miami (Florida) and Pharmaloop, S.L. in Alcalá de Henares (Madrid). Both companies are subsidiaries of Laboratorios Salvat S.A.

The first eye drug with nanoparticles

This drug, which treats pain and inflammation in patients who have undergone eye surgery, presents two main innovations. First, the type of corticosteroid used, which is classified as “superpotent”, and which had not been used before in eye drops. Secondly, the type of formulation used, a nanoemulsion that has many advantages over current treatments and has never been used before in eye corticosteroids. 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 the USA alone, around four million cataract surgeries are performed every year. This drug under development will be a great advance in the treatment of pain and inflammation after eye surgery, both because of its active ingredient and its formulation.