Clinicians familiar with off-label steroid use to quickly quell dry eye now have an on-label way to do it, as the FDA approved a new loteprednol formulation today. Marketed as Eysuvis by Kala Pharmaceuticals, the drug is an ophthalmic suspension of loteprednol etabonate, at 0.25% concentration, approved for up to two weeks of therapy. Eysuvis uses mucus-penetrating particles to enhance absorption, according to a Kala press release.
The approval stems from positive outcomes of four clinical trials (three Phase III and one Phase II) that demonstrated improvements in both the signs and symptoms of dry eye disease, the Kala release says. Specifically, conjunctival hyperemia and ocular discomfort severity both showed statistically significant gains from treatment. The company also says that Eysuvis was well-tolerated across the four trials, with adverse events and intraocular pressure increases comparable to that observed with vehicle.
Kala says it will launch Eysuvis by the end of the year.
Full prescribing information is available at www.eysuvis.com.