Case Study: Allergan achieves 18-month FDA approval and scalable 3M/year production of TrueTear with Flex

Allergan - Customer Case Study

Allergan partnered with Flex to bring TrueTear®, the world’s first intranasal neurostimulating device for dry eye, from pilot to market. Allergan faced a novel manufacturing challenge—maintaining a precise hydration cycle and developing new disposable-tip and fluid-dispensing processes—while meeting tight FDA timelines and scaling from clinical builds to commercial production.

Flex applied Design for Manufacturability and Sketch-to-Scale solutions, designing the disposable tip and automation, maturing the design for repeatable production, validating processes and documentation for FDA filing, and setting up production in its Gushu, China facility. The program reached FDA approval in 18 months, produced an initial 60,000 units and is projected to scale to 3 million units annually, demonstrating Flex’s ability to take a first-of-kind device to market on schedule.

Allergan

Chris Stivers

Program Lead, Manufacturing