Short-term dry eye treatment option receives FDA approval
This article has been reviewed by Edward Holland, MD
The first prescription ocular corticosteroid indicated specifically for the short-term treatment of dry eye (DED) – Loteprednol etabonate 0.25% ophthalmic suspension (Eysuvis; Kala Pharmaceuticals) – has received FDA approval, which comes with expectations for rapid relief from signs and symptoms. of DED.
Being the first drug approved in this class for the short-term treatment of DED also means that it differs from the plethora of DED treatments available.
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Although Cyclosporine 0.05% ophthalmic emulsion (Restasis; Allergan) and lifitegrast 5% ophthalmic solution (Xiidra; Novartis) are good chronic anti-inflammatory drugs, the difference is that reaching the maximum of benefit often takes weeks or even months.
“With Eysuvis, patients will get immediate relief from the signs and symptoms of dry eye due to the rapid action of corticosteroids against inflammation,” said Edward Holland, MD, director of corneal services at the Cincinnati Eye Institute and professor of ophthalmology at the University. of Cincinnati. “Clinical trials of the drug showed symptomatic improvement started within 1 or 2 days of instillation of gout. Having an approved corticosteroid will change the way we deal with dry eye disease. “
Recently, one realization that emerged from the DED study is that most of the patient population experiences relapses, on average, 4 to 6 times a year, according to Holland. In addition, the majority of the 17 million patients with DED report experiencing flare-ups rather than continuous symptoms.
For patients who treat flare-ups when they occur, short-term treatment is probably sufficient. There are patients with more severe symptoms who are taking chronic medications who will also have flare-ups and need additional treatment.
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The currently available formulations do not relieve these painful episodes. Some patients may be completely asymptomatic between relapses and do not require maintenance therapy, but want to treat relapses as they occur.
Other patients need maintenance treatment, but may experience episodes of DED outbreaks despite ongoing treatment.
“Previously, we didn’t have therapy that could target flare-ups,” Holland said.
The AMPPLIFY Mucus Penetrating Particle (MPP) drug delivery technology developed by Kala Pharmaceuticals appears to be essential for the rapid onset of symptomatic relief experienced by patients. MPP enhances the penetration of loteprednol etabonate through the ocular mucosal layer, thereby improving drug delivery to ocular surface tissues to target immune responses that cause acute DED outbreaks.
“Loteprednol etabonate is a very good corticosteroid with a good safety profile and high potency,” said Holland. “I think it will be very effective and maybe a first line prescription treatment for all patients with dry eye.”
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The FDA approval was based on the results of 4 clinical trials – 1 phase 2 trials and 3 phase 3 trials – which reported significant improvements in the signs and symptoms of dry eye.
In STRIDE 3 (NCT03616899), the latest multicentre, randomized, double-blind, placebo-controlled, parallel-arm phase 3 trial, the effects of Eysuvis were compared in 901 patients with DED (447 who received the active drug and 454 control patients) who instilled drops 4 times a day for 2 weeks.
Conjunctival hyperemia improved significantly after 2 weeks of administration in phase 3 trials, and in 2 of 3 phase 3 trials ocular discomfort also improved significantly.
Treatment is approved for a maximum of 2 weeks. Because dry eye is characterized by inflammation, the hope is that the inflammation is eliminated and the tendency to progress – creating the potential need for chronic treatment – will be alleviated, Holland said.
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In all trials, the most common side effect was pain associated with instilling drops.
Holland anticipates a “new era in the treatment of dry eye” and says Eysuvis holds promise for the millions of patients suffering from flare-ups.
“For the first time, we will be able to offer patients with dry eye a treatment option that rapidly relieves the signs and symptoms of the disease and is safe and well tolerated,” he said.
Kala Pharmaceuticals plans to launch Eysuvis in the United States by the end of 2020.
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Edward Holland, MD,
Holland is a consultant for Kala Pharmaceuticals.