FDA Approves Glaukos' New Drug Application for iDose TR
December 14 2023 - 7:04AM
Dow Jones News
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)
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