Last week, the FDA approved EYSUVIS™ (loteprednol etabonate 0.25% ophthalmic suspension) from Kala Pharmaceuticals for the short-term treatment of signs and symptoms of DED. EYSUVIS features proprietary AMPPLIFY® mucus-penetrating particle (MPP) Drug Delivery Technology to enhance penetration of loteprednol etabonate (LE) into target tissue on the ocular surface. Prior to this new drug, there were no FDA-approved ocular corticosteroids specifically indicated for the treatment of dry eye disease. Kala Pharmaceuticals plans to launch EYSUVIS in the US by year’s end.
With the approval of EYSUVIS, we gain an important weapon in the fight against the signs and symptoms of dry eye. In particular, I believe EYSUVIS will help patients who experience acute flare-ups of their disease, which tend to occur about three to six times per year in many chronic DED cases. This new therapy might also make a good first-line therapy for those patients experiencing episodic dry eye who need rapid resolution. EYSUVIS is approved for up to two weeks of treatment and is dosed QID.
Across four FDA clinical trials, this new drug demonstrated significant improvement in signs and symptoms—including ocular discomfort (p=0.0002) and conjunctival hyperemia, both after two weeks of treatment. Two weeks is a remarkably quick time frame for clinically significant effect, and in fact the day eight symptom improvement for ocular discomfort was statistically significant (p=0.0282), as was the very important sign of total corneal staining (p=0.0042). From a safety standpoint, EYSUVIS was well-tolerated, with adverse events and intraocular pressure increases comparable to the vehicle.
As a clinician treating an increasing number of dry eye patients seeking relief from this chronic disease, it’s exciting to see the FDA approval of a corticosteroid for the short-term treatment of both signs and symptoms of dry eye disease.
KEY TAKEAWAY: With last week’s FDA approval of EYSUVIS™ from Kala Pharmaceuticals, we now have an ocular corticosteroid approved specifically for the treatment of DED.
Supported by an independent medical grant from Kala Pharmaceuticals
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