Salvat plans to launch the first global ocular corticosteroid with nanoemulsion in 2023 for the inflammation and pain after ocular surgery

    • Phase III clinical trials conducted in US confirm that clobetasol is effective and safe in the treatment of inflammation and pain after cataract surgery.
    • The pharmaceutical company has begun the process with health authorities to market the new corticosteroid worldwide by the middle of next year.
    • The company has patented a pioneering technology, IMPACT-SVT®, which for the first time in the field of ophthalmology will make possible to use this active ingredient as nanoemulsion.
    • With this project, of 20 million euros investment, Salvat takes another step forward in its strategy to establish itself as a key player in the field of ophthalmology at an international level.

    Salvat, international manufacturer of products like Otovel and Cetraxal, has successfully finished the phase III clinical trials of its new and innovative ocular corticosteroid with clobetasol for the treatment of inflammation and pain in cataract surgery patients. The trials, conducted during 2020 and 2021 in more than 400 patients in the United States, and in more than 40 specialized centers, have demonstrated the efficacy and safety of clobetasol. The company has initiated the approval application procedures with the Food and Drug Administration (FDA) and the European health authorities to launch the new corticosteroid worldwide in the second half of 2023.

    Bringing the Strongest Corticosteroid to the Global Ophthalmology Market

    It’s the first time that this active ingredient, considered a “superpotent” corticosteroid will be used in the field of ophthalmology. Moreover, its formulation as a nanoemulsion with its proprietary IMPACT-SVT® technology and the presentation in single-dose vials offers superior advantages over other alternatives on the market. In addition to its efficacy and safety, clinical trials have shown that, unlike many other corticosteroids, it does not increase intraocular pressure. Another differential aspect is that it does not require a gradual decrease in dosage before the end of treatment, since it has been proven that after the initial 14 days of treatment and 14 more days of follow-up without medication, there is no rebound inflammation or pain. Finally, the nanoemulsion technology, IMPACT-SVT® delivers the lowest drug concentration by dissolving clobetasol in nanodroplets size. This results in a much more comfortable application providing maximum adherence, penetration and avoids blurred vision to the patient.

    Trials with positive results

    The two clinical trials of the new drug conducted last year in the United States involved a total of 426 cataract surgery patients, of whom 281 received clobetasol and 145 received a placebo. 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.

    Single Dose Manufacturing Technology

    One of the advantages of Salvat’ BFS technology is to manufacture the product in a totally sterile environment, thus ensuring a sterile single dose vial at the time of application. The unit dose format offers a more convenient use and also optimizes the compliance with the treatment, since it allows the exact dose administration. This innovative product will be the first unit dose therapy on the market indicated for the treatment of inflammation and pain after ocular surgery.

    Designed with BFS technology, the new drug will be produced in the manufacturing line of Salvat USA Inc. in Miami (Florida) and in the Pharmaloop S.L. plant, in Madrid. Both companies are subsidiaries of Laboratorios Salvat S.A. Following the processing and application for approval by the various health authorities, Salvat expects to start marketing its new corticosteroid worldwide in mid-2023. The main focus will be on the United States and Europe, where the company has its own sales network, in addition to its headquarters in Barcelona and the manufacturing plant located in Madrid. In the US market and other countries, distribution will be done through local strategic partners.

    Salvat, a key player in ophthalmology

    In addition to the development of this ocular corticosteroid, which has involved an investment of more than 20 million euros, Salvat is working on four other projects in the field of ophthalmology, such as glaucoma, dry eye, diabetic retinopathy and blepharitis.

    For Alberto Bueno, CEO of Salvat, “the launch of the new corticosteroid and the rest of the projects that are underway reinforce our ophthalmology line as one of our main areas of research and development, and strengthen the company’s strategy to position itself as one of the main players in the field of ophthalmology worldwide in the coming years.”