Alcon Receives FDA Approval for Tryptyr to Treat Dry Eye Disease

爱尔康公司生产的Tryptyr获FDA批准用于治疗干眼症

May 30, 2025

2025年5月30日

Alcon has received U.S. FDA approval for Tryptyr (acoltremon ophthalmic solution) 0.003%, formerly known as AR-15512, for the treatment of signs and symptoms of dry eye disease (DED). Tryptyr is a first-in-class TRPM8 receptor agonist and represents a novel treatment option targeting neuromodulation to stimulate natural tear production..

阿尔康公司已获得美国FDA批准，用于治疗干眼病（DED）症状的Tryptyr（乙酰特雷蒙滴眼液）0.003%，该药物曾被称为AR-15512。Tryptyr是一种首创的TRPM8受体激动剂，代表了一种通过神经调节刺激天然泪液生成的新型治疗选择。

FDA Approval Marks New Development in Alcon’s Prescription Portfolio

FDA批准标志着爱尔康处方药产品线的新发展

Tryptyr marks the first FDA-approved prescription pharmaceutical from Alcon since the company became an independent, publicly traded eye care company in 2019, following its separation from Novartis. Alcon acquired Tryptyr through its 2022 acquisition of Aerie Pharmaceuticals in a deal valued at approximately $770 million..

Tryptyr 标志着自 2019 年公司从诺华分离出来成为一家独立的、公开上市的眼科护理公司以来，爱尔康获得的首个 FDA 批准的处方药。爱尔康通过其在 2022 年以约 7.7 亿美元收购 Aerie Pharmaceuticals 的交易获得了 Tryptyr。

“We look forward to making this new treatment available to millions of patients affected by dry eye disease. We believe Tryptyr is an exciting new treatment option for a significant number of dry eye patients given its rapid efficacy,”

“我们期待让数百万干眼病患者用上这种新疗法。我们认为，鉴于其快速见效的特点，Tryptyr 将为众多干眼症患者带来令人振奋的全新治疗选择。”

said David Endicott, CEO of Alcon.

爱尔康首席执行官大卫·恩迪科特表示。

Clinical Trial Results Support FDA Approval

临床试验结果支持FDA批准

The FDA’s approval is supported by data from two Phase 3 clinical trials—COMET-2 and COMET-3—which evaluated over 930 patients with a history of DED, randomized 1:1 to receive Tryptyr or vehicle.

美国食品药品监督管理局（FDA）的批准得到了两项三期临床试验——COMET-2 和 COMET-3——的数据支持，这些试验评估了 930 多名有干眼病（DED）病史的患者，随机以 1:1 的比例接受 Tryptyr 或安慰剂治疗。

Key findings include:

主要发现包括：

• Day 14 tear production improvement:

• 第14天泪液分泌改善：

• COMET-2: 42.6% (Tryptyr) vs. 8.2% (vehicle)

• COMET-2：42.6%（Tryptyr）vs. 8.2%（对照组）

• COMET-3: 53.2% (Tryptyr) vs. 14.4% (vehicle)

• COMET-3：53.2%（Tryptyr）vs. 14.4%（对照组）

• (Both P < 0.0001)

• （两者 P < 0.0001）

• Tryptyr demonstrated statistically significant improvement in natural tear production as early as Day 1 and maintained results through Day 90.

• Tryptyr在第1天就显示出在自然泪液生成方面具有统计学意义的显著改善，并且在第90天仍保持了这一效果。

• The most common adverse reaction reported in clinical trials was instillation site pain (50%).

• 临床试验中报告的最常见的不良反应是滴注部位疼痛（50%）。

Novel Mechanism of Action: TRPM8 Receptor Agonism

新颖的作用机制：TRPM8受体激动作用

Acoltremon, the active ingredient in Tryptyr, is believed to act as an agonist of TRPM8 thermoreceptors—sensory receptors involved in cool-temperature detection. Preclinical studies suggest that TRPM8 stimulation activates trigeminal nerve pathways, enhancing basal tear secretion.

Tryptyr中的活性成分Acoltremon被认为可作为TRPM8热受体的激动剂——这种感觉受体参与低温检测。临床前研究表明，TRPM8刺激会激活三叉神经通路，增加基础泪液分泌。

Despite these findings, Alcon notes that the exact mechanism of action of Tryptyr in dry eye disease remains unknown.

尽管有这些发现，爱尔康指出，Tryptyr 在干眼病中的确切作用机制仍然未知。

Dosing and Commercial Availability

剂量与商业可得性

Tryptyr will be available in single-dose vials, administered as one drop per eye, twice daily.

Tryptyr 将以单剂量小瓶供应，每日两次，每次每只眼睛滴一滴。

Alcon anticipates launching Tryptyr in the United States in Q3 2025, with plans to expand to additional markets globally in the future.

爱尔康预计将在2025年第三季度在美国推出Tryptyr，并计划未来在全球更多市场进行扩展。

References

参考文献

Data on File for COMET-2 Phase 3 Study. Alcon 2025.

COMET-2 第三阶段研究的存档数据。Alcon 2025。

Data on File for COMET-3 Phase 3 Study. Alcon 2025.

COMET-3 第三阶段研究的存档数据。Alcon 2025。

TRYPTYR® US FDA Prescribing Information. 2025.

TRYPTYR® 美国FDA处方信息。2025年。