Senju Pharma has launched a new drug for dry eye disease (DED) in Japan, Avarept, which is the first drug in the TRPV1 antagonist class to reach the market.

千寿制药在日本推出了一款治疗干眼症（DED）的新药Avarept，这是首个上市的TRPV1拮抗剂类药物。

Licensed from fellow Japanese drugmaker Mochida, Avarept (motugivatrep) ophthalmic suspension has been launched at a list price of JPY 577.50 ($3.63) per 5ml bottle and will be distributed in Japan by Takeda.

从日本同行制药公司Mochida获得许可后，Avarept（motugivatrep）眼用混悬液已以每5毫升瓶577.50日元（3.63美元）的定价上市，并将由武田药品在日本分销。

DED is a common inflammatory disorder estimated to affect

DED是一种常见的炎症性疾病，估计会影响

over 20 million people

超过2000万人

in Japan and its incidence is rising with the country's ageing population, long-term use of contact lenses, and excessive screen time. It is characterised by insufficient moisture and lubrication in the anterior surface of the eye, leading to dryness, inflammation, pain, discomfort, irritation, diminished quality of life and, in severe cases, permanent visual impairment..

在日本，其发病率随着人口老龄化、长期使用隐形眼镜和过度屏幕时间而上升。它表现为眼睛前表面缺乏足够的湿润和润滑，导致干燥、炎症、疼痛、不适、刺激、生活质量下降，严重情况下甚至会造成永久性视力损伤。

Existing therapy for dry eye disease – based on lubricating eyedrops and drugs to reduce inflammation and increase tear production – is generally regarded as inadequate and can take a long time to deliver improvements in symptoms.

现有的干眼病治疗方法——基于润滑眼药水和减少炎症、增加泪液分泌的药物——通常被认为不够有效，且需要很长时间才能改善症状。

Avarept's approval came on the back of the Japanese 3-02 clinical trial, which met its primary endpoint by showing a statistically significant improvement in dry eye symptom severity, as measured by the DEQS score, compared to placebo.

Avarept 的批准是基于日本 3-02 临床试验的结果，该试验达到了主要终点，与安慰剂相比，通过 DEQS 评分测量，显示出在干眼症状严重程度上有统计学意义的改善。

'We are very pleased that the TRPV1 antagonist, which has been researched over many years since its discovery, has now been launched through Senju's extensive development efforts as the world's first DED treatment with TRPV1 antagonistic activity,' said Mochida's head of business development, Tomokazu Matsusue..

“我们非常高兴，自发现以来经过多年研究的TRPV1拮抗剂，现在通过千寿制药的广泛开发努力，作为全球首个具有TRPV1拮抗活性的DED治疗方法成功上市，”百利达业务发展主管松末友和表示。

'We sincerely hope that Avarept will contribute to improving symptoms in the many patients suffering from DED,' he added.

“我们真诚地希望，Avarept将有助于改善众多DED患者的症状，”他补充道。

TRPV1 antagonism has been proposed as a therapeutic strategy for many years, but initial efforts focused on its potential as a systemic approach for pain relief. Early candidates from the likes of Amgen and AbbVie were held back by side effects, including hyperthermia, but newer candidates have been developed that reduce that risk..

多年来，TRPV1拮抗作用一直被视为一种治疗策略，但最初的努力集中在将其作为缓解疼痛的全身性方法。Amgen和AbbVie等公司早期的候选药物因副作用（包括体温过高）而受阻，但已经开发出降低该风险的新候选药物。

Current drug candidates are being developed for a range of indications, and include AlzeCure's ACD440 for neuropathic pain, Pila Pharma's XEN-D0501 for obesity and type 2 diabetes, Serentrix's SER014 for DED, pain, and irritable bowel syndrome (IBS), and Sylentis' DED candidate tivanisiran (SYL1001)..

当前的药物候选物正在针对一系列适应症进行开发，包括AlzeCure的ACD440用于神经性疼痛，Pila Pharma的XEN-D0501用于肥胖和2型糖尿病，Serentrix的SER014用于干眼病（DED）、疼痛和肠易激综合症（IBS），以及Sylentis的干眼病候选药物tivanisiran（SYL1001）。

Another novel treatment for DED, Aldeyra Therapeutics' RASP inhibitor

另一种治疗DED的新方法，Aldeyra Therapeutics的RASP抑制剂

reproxalap

瑞普罗沙拉普

, was

，是

turned down

拒绝

by the US FDA for the third time in March for 'a lack of substantial evidence' of its efficacy. The company has requested a meeting with the FDA to discuss the decision, but has said it will not carry out any further trials of the drug in DED.

美国食品药品监督管理局（FDA）在三月份第三次因“缺乏充分的有效性证据”拒绝了该药物。公司已请求与FDA召开会议讨论这一决定，但表示不会在DED领域对该药物进行任何进一步的试验。