2021年12月14日 -- FDA批准的一种新的滴眼药可以取代数百万患有与年龄相关的视力模糊的美国人的老花镜。
该产品名为Vuity,于10月获得FDA批准,并于上周上市。新药在大约15分钟内开始工作,并提供更敏锐的视力6至10小时。
Vuity是第一个FDA批准的眼药水,用于治疗称为老花眼的疾病,老花眼往往会影响40岁及以上的人。处方药利用眼睛的自然能力来缩小其瞳孔大小。
"减小瞳孔大小可以扩大景深或聚焦深度,这可以让你自然地在不同的范围内对焦,"临床试验的首席研究员George Waring医学博士告诉CBS新闻。
对于使用滴剂的人来说,一开始可能很难在物体之间调整焦点。在临床试验期间,滴剂有轻微的副作用,如头痛和眼睛发红。
"这是我们预计长期可以很好地容忍的事情,但这将以正式身份进行评估和研究,"Waring说。
老花眼可以通过眼科医生的基本眼科检查来诊断,根据Allergan的新闻稿,它制造了滴剂。这是一种常见且进行性眼部疾病,影响着1.28亿美国人。
Allergan说,在临床试验中,750名患有老花眼的参与者测试了滴剂,并且"统计学上显着的比例"能够在阅读图表上读取三条或更多条额外的线条。
这些滴剂适用于轻度至中度老花眼病例,不应在夜间驾驶或在低光照条件下进行活动时使用。滴剂也不会帮助患有其他眼部疾病的人,例如近视(近视)和远视(远视)。
滴剂最适合40-55岁,65岁以后效果较差。
据哥伦比亚广播公司新闻报道,30天的供应成本约为80美元,不在保险范围内。
New FDA-Approved Eyedrops Could Improve Close-Up Vision
By
Carolyn Crist
Dec. 14, 2021 -- A new
FDA-approved eyedrop medicine could replace reading glasses for
millions of Americans who have age-related blurry vision.
The product, called Vuity, was approved by the FDA in October and went on the market last week. The new medicine begins working in about 15 minutes and provides sharper vision for 6 to 10 hours.
Vuity is the first FDA-approved eyedrop to treat the condition known as presbyopia, which tends to affect people ages 40 and older. The prescription drug uses the eye’s natural ability to reduce its pupil size.
“Reducing the pupil size expands the depth of field or the depth of focus, and that allows you to focus at different ranges naturally,” George Waring, MD, the lead researcher for the clinical trial, told CBS News.
For people who use the drops, it may be hard to adjust their focus
between objects at first. During the clinical trial, the drops had
mild side effects such as headaches and red eyes.
“This is
something that we anticipate will be well-tolerated long-term, but
this will be evaluated and studied in a formal capacity,” Waring said.
Presbyopia can be diagnosed through a basic eye exam by an eye doctor, according to a news release from Allergan, which makes the drops. It’s a common and progressive eye condition that affects 128 million Americans.
In the clinical trial, 750 participants with presbyopia tested the drops, and a “statistically significant proportion” were able to read three or more additional lines on a reading chart, Allergan said.
The drops are intended for mild to intermediate cases of presbyopia and shouldn’t be used when driving at night or doing activities in low-light conditions. The drops also won’t help people with other eye conditions, such as myopia (nearsightedness) and hyperopia (farsightedness).
The drops work best for ages 40-55 and are less effective after age 65.
A 30-day supply costs about $80 and is not covered by insurance, CBS
News reported.
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