Investing.com -- Glaukos Corporation (NYSE:GKOS) stock climbed 6.3% on Wednesday after the company announced that the U.S. Food and Drug Administration (FDA) has approved its NDA labeling supplement allowing for re-administration of iDose TR using a repeat treatment protocol.
The approval provides physicians with the ability to re-administer iDose TR more than once in patients who maintain a healthy cornea, defined by specific corneal endothelial cell density parameters. This enhancement expands treatment options for glaucoma patients and offers greater flexibility in long-term management.
"We are pleased to announce this important labeling enhancement for iDose TR, which should help expand access for patients who may benefit from repeat treatment and provide physicians with greater flexibility in managing their glaucoma patients over time," said Thomas Burns, Glaukos chairman and chief executive officer.
iDose TR is an intracameral procedural pharmaceutical therapy designed to continuously deliver therapeutic levels of travoprost inside the eye for extended periods. The treatment addresses patient non-compliance issues and chronic side effects associated with traditional topical glaucoma medications.
Clinical studies have demonstrated a favorable long-term corneal safety profile for iDose TR, with no clinically significant corneal endothelial cell loss observed through three years in both Phase 3 and Phase 2b studies.
Following the announcement, BTIG analyst Ryan Zimmerman raised his price target on Glaukos to $131 from $123 while maintaining a Buy rating. The expanded label represents a significant improvement from the previous limitation of one iDose per eye per lifetime, giving the company greater optionality in the interventional glaucoma space.
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