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Glaukos Gets Approval For Glaucoma Implant, With A Catch

Label Does Not Authorize Re-Implantation Of iDose TR

 
• By Joseph Haas

Glaukos got US FDA approval for its intracameral implant of travoprost for glaucoma and hopes the product will work for up to three years. It also set a high goal for first-year sales.

Glaukos gets FDA's ok for implantable glaucoma product • Source: Alamy

Glaukos Corporation got US Food and Drug Administration approval of iDose TR, its intracameral implant of travoprost for glaucoma, on 14 December, but it appears the company’s regulatory work is only beginning because the product label does not authorize reimplantation of the drug-device combination product.

Key Takeaways

  • Glaukos won FDA approval for its drug-device implant of travoprost for glaucoma and ocular hypertension patients, but the label does not advise re-implantation.

  • IDose TR will compete both with eye drops and AbbVie’s Durysta, a bimatoprost implant, in the glaucoma market

Intended to augment and eventually replace the regimen of eye drops glaucoma patients use on a daily basis and to improve therapeutic compliance, iDose will compete directly against AbbVie Inc.’s Durysta, which is an injectable implant of bimatoprost approved by the FDA in March 2020

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