FDA approves Eysuvis for short-term dry eye disease treatment
The FDA has approved Eysuvis for the short-term treatment of dry eye disease signs and symptoms, according to a press release from Kala Pharmaceuticals.
Eysuvis (loteprednol etabonate ophthalmic suspension 0.25%) is the first ocular corticosteroid approved by the FDA for the treatment of dry eye disease. Kala is planning to launch it in the U.S. by the end of the year.
The approval is based on results from four clinical trials that demonstrated significant improvement in signs and symptoms of dry eye disease. Eysuvis is approved for up to 2 weeks of treatment.
In three phase 3 trials, “statistical significance was achieved after 2 weeks of dosing for the sign endpoint of conjunctival hyperemia,” the release said. For the symptom endpoint of ocular discomfort severity, statistical significance was reached in two of the phase 3 trials.
Eysuvis was well tolerated in the four trials. Adverse events and IOP increases were comparable to those seen with vehicle.
Perspective
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A dry eye flare is characterized by acute exacerbation of the signs and symptoms of dry eye. A flare is rapid onset, is inflammatory driven and has many triggers in the environment, such as seasonal allergies, digital screen time, contact lenses, and cold or dry air. The average patient has somewhere between five and 10 dry eye flares per year, whether they are on maintenance therapy for dry eye. So, this is going to help manage those patients.
For some patients, Eysuvis will be the only treatment they will need to take, managing flares when they are symptomatic. For others, Eysuvis can be added to their maintenance therapy to manage flares.
I intend to use Eysuvis as first-line therapy for my patients with dry eye. Patients with dry eye symptoms and signs want immediate relief, and Eysuvis was shown in clinical trials to provide this desired rapid effect. Eysuvis quickly quiets the eye and has an excellent safety profile.
Eysuvis may also be appropriate for induction therapy for patients being placed on long-term maintenance treatment, for patients on long-term therapy who experience breakthrough dry eye flares and patients undergoing ocular surgery who suffer from dry eye.
The approval of Eysuvis is a big breakthrough in the management of dry eye. Eye care professionals want on-label treatments, and because steroids have some side effects, not having an on-label steroid was a barrier.
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