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Allergan Granted Marketing Authorization By The FDA For ...
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G a 45 Day Period with Application of TrueTear Protocol Date: March 10, 2017 Clinical Trial Protocol: OCUN-029 Sponsor: Allergan, Inc. Prospective, Single-Arm Clinical Trial to Evaluate Acute Dry Eye Symptom Relief Assessed During Exposure to a Controlled Adverse Environment (CAE ) Following a 45 Day Period with Application of TrueTear Protocol Number: OCUN-029 Original Protocol: March 10, 2017 Device Name: TrueTear Sponsor: Allergan, Inc. Contract Research Organization:.
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Ophthalmic FAQ
The iTear100 was FDA approved on May 1, 2020—just as Allergan discontinued its TrueTear neurostimulation device.
TrueTear, Allergan said in a statement, is the first FDA-approved device to increase tear production in adult patients using neurostimulation. The handheld stimulator includes disposable tips that are placed in the nasal cavity, which induces tear production.
The iTear100 was FDA approved on May 1, 2020—just as Allergan discontinued its TrueTear neurostimulation device.
TrueTear® works by using a process called neurostimulation. The tip of the device is inserted through the nasal cavity and, when activated, painlessly stimulates the glands surrounding the eyes. The tiny pulses of energy generated by the devices send signals to the brain to produce your body's own natural tears.
Surgeons say that the base price of the TrueTear is $750 and a month's supply of disposable tips costs $250, although Allergan does offer some rebates to help defray costs. In addition to stimulating the lacrimal gland in aqueous-deficient dry eye, Dr.
LACRIMAL Related content
UPDATE: All Eyes on Allergan
Mar 16, 2018 — Allergan alleged patent infringement based on the generic drug...
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