Glaukos Corp. (GKOS), Wednesday announced that the U.S. Food and Drug Administration has approved an NDA labeling supplement allowing for re-administration of iDose TR using a repeat treatment protocol, validating the therapy's established and proven safety profile.
The first-of-its-kind, long-duration, intracameral procedural pharmaceutical therapy is intended to improve the standard of care by addressing the ubiquitous patient non-compliance issues and chronic side effects associated with topical glaucoma medications.
The agency's approval comes in response to Glaukos' 2025 NDA labeling supplement application, and reflects accumulated clinical evidence supporting the safety and tolerability of repeat use for iDose TR.
The company noted that iDose TR has demonstrated a favorable long-term corneal safety profile, with no clinically significant corneal endothelial cell loss observed through three years across both the Phase 3 and Phase 2b studies.
In the pre-market hours, GKOS is trading at $119.99, up 1.08 percent on the New York Stock Exchange.
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