Salvat Laboratories has launched a phase 3 clinical trial that will assess the safety of SVT-15473 (Clobetasol propionate ophthalmic nanoemulsion, 0.05%) for treating inflammation and pain in pediatric patients following cataract surgery.
Refresh me on the company.
Founded in 1955 and based in Barcelona, Spain (with a U.S. subsidiary in Miami, Florida), the internal pharmaceutical company develops, manufacturers, and markets branded pharmaceutical products in ophthalmology as well as otolaryngology, urology, gastroenterology, consumer healthcare, and other therapeutic areas.
Click here and scroll down for a list of ophthalmic products.
Any proprietary technology?
Actually, yes; IMPACT-SVT is the company’s patented nanoemulsion drug delivery technology designed to improve drug penetration, bio-adhesion, and overall comfort.
Now talk about SVT-15473.
SVT-15473 is the first ocular corticosteroid formulated as a nanoemulsion developed using clobetasol—a steroid typically used to reduce swelling and itching associated with skin conditions.
How is it administered?
SVT-15473 is administered via the IMPACT-SVT as a single-dose vial over the course of a 14-day treatment period.
To note: the eye drop was designed with Blow-Fill-Seal (BFS) technology, which is a sterile, advanced, and automated manufacturing system for single-dose vials.
Is there clinical data on it yet?
The therapy has demonstrated its safety and efficacy in two phase 3 Clobetasol Propionate Ophthalmic Nanoemulsion, 0.05% in the Treatment of Inflammation After Cataract Surgery in Pediatric Population (CLOSE) clinical trials:
CLOSE-1 (NCT04246801)
CLOSE-2 (NCT04249076)
And …
In both studies, SVT-15473 has been shown to have a minimal effect on intraocular pressure (IOP), no rebound effect over the treatment period, and—as a result—requires no dose tapering following treatment.
Also of importance: Salvat submitted a new drug application to the FDA for the therapy in October 2022.
Gotcha. So what’s with this new trial?
The multicenter, randomized, evaluator-blinded phase 3 CLOSE-3 clinical trial (NCT05724446) is assessing the use of SVT-15473 in an estimated 60 pediatric patients (ages 0 to 3) diagnosed with cataracts who have either undergone cataract surgery in one eye (with no complications) or are candidate for cataract surgery.
See here for additional patient inclusion and exclusion criteria.
What else?
Each of the patients will be randomly divided into two equal groups:
Group 1→ Treated with SVT-15473
Group 2→ Treated with prednisolone acetate ophthalmic suspension, 1%
Groups will receive either one drop of SVT-15473 (Group 1) or one drop of prednisolone (Group 2), four times a day (QID) beginning the day after surgery for 14 days and then followed by a 14-day tapering period.
What’s being measured?
Per Clinical Trials.gov, primary outcome is assessing the safety of SVT-15473 vs prednisolone at Day 43, as measured by the number, frequency, severity, and relationship to indocyanine (ICG) green-mediated photothrombosis IMP of adverse events (AEs) up to the last visit.
What about secondary outcomes?.
These include the efficacy of SVT-15473 on ocular inflammation and pain in patients on Day 15, as measured by:
Inflammation → number of patients with anterior chamber inflammation of grade 0 (scale 1-5).
Pain → Change in the face, legs, activity, cry, consolability (FLACC) behavior scale score.
What else to know?
The study is being conducted in Europe—a first for topical corticosteroids in this patient population—based on an agreement with the FDA as part of the ongoing approval process for SVT-15473. Per Salvat, the trial is complementary and will not interfere with the process.
So when can we expect results?
According to Clinical Trials.gov, the study is slated to complete by August 2024. Stay tuned in the meantime for more details and updates on the FDA approval process!