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| Share Name | Share Symbol | Market | Type |
|---|---|---|---|
| Glaukos Corporation | NYSE:GKOS | NYSE | Common Stock |
| Price Change | % Change | Share Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
|---|---|---|---|---|---|---|---|---|
| -0.74 | -0.68% | 108.53 | 109.09 | 107.22 | 109.09 | 327,501 | 01:00:00 |
From Nov 2023 to May 2024
By Dean Seal
Glaukos said federal regulators have approved a new drug application for iDose TR, a treatment for ocular hypertension and open-angle glaucoma.
The ophthalmic medical technology and pharmaceutical company said Thursday morning that the Food and Drug Administration approved the application for a single administration per eye of iDose TR for the reduction of intraocular pressure in patients with ocular hypertension or open-angle glaucoma.
Glaukos said iDose TR is designed to continuously deliver therapeutic levels of a proprietary formulation of travoprost inside the eye for extended periods of time.
The approval is based on two pivotal Phase 3 trials that successfully achieved their primary efficacy endpoints through three months and demonstrated a favorable tolerability and safety profile through 12 months.
Glaukos intends to start initial commercial launch activities for iDose TR in the latter part of the first quarter of 2024.
Write to Dean Seal at dean.seal@wsj.com
(END) Dow Jones Newswires
December 14, 2023 07:49 ET (12:49 GMT)
Copyright (c) 2023 Dow Jones & Company, Inc.
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