Shares of Glaukos Corporation (NYSE:GKOS) climbed 6.3% on Wednesday following an announcement that the U.S. Food and Drug Administration has approved an NDA labeling supplement allowing iDose TR to be re-administered under a repeat treatment protocol.
The regulatory update grants physicians the option to perform more than one iDose TR administration in patients who retain a healthy cornea, as defined by specific corneal endothelial cell density parameters. That change gives clinicians additional flexibility in managing patients over time and broadens therapeutic options in the interventional glaucoma space.
"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 directly inside the eye over extended durations. The approach is intended to address common challenges with topical glaucoma medications, including patient non-compliance and chronic side effects associated with eye drops.
Clinical data cited by the company indicate a favorable long-term corneal safety profile: no clinically significant corneal endothelial cell loss was observed through three years in both Phase 3 and Phase 2b studies.
Market observers quickly reacted to the labeling update. BTIG analyst Ryan Zimmerman raised his price target on Glaukos to $131 from $123 while maintaining a Buy rating. The revised label replaces the prior limitation that allowed only one iDose per eye for a patient's lifetime, creating additional optionality for the company in interventional glaucoma treatments.
The approval and subsequent analyst action highlight both a clinical and a commercial inflection point for iDose TR. By enabling repeat administration in patients meeting defined corneal endothelial cell density criteria, the label change alters the product's utilization potential in long-term disease management.
Note: The article reports on the FDA-approved labeling supplement, the company statement, clinical study findings through three years, the stock movement that followed the announcement, and the analyst price-target change as described above.