Read nextFDA approves Eysuvis for short-term dry eye disease treatment
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The FDA has approvedEysuvisfor 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.
在三个第三阶段试验中，“结膜充血的标志终点2周后，实现了统计显着性，”该版本说。对于眼部不适的症状终点，在第3阶段试验的两个试验中，达到了统计显着性。
Eysuvis was well tolerated in the four trials. Adverse events and IOP increases were comparable to those seen with vehicle.
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干眼耀斑的特征是干眼症的体征和症状急性加剧。耀斑快速发作，是炎症驱动的，并且在环境中有许多触发因素，例如季节性过敏，数字屏幕时间，隐形眼镜以及冷空气或干燥空气。普通患者每年有五到10个干眼耀斑，无论他们是否正在维护干眼症进行维护治疗。因此，这将有助于管理这些患者。
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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