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Prospective, Randomized Phase III Study Comparing Two Models of a Travoprost Intraocular Implant to Timolol Maleate Ophthalmic Solution, 0.5%

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Trial Profile

Prospective, Randomized Phase III Study Comparing Two Models of a Travoprost Intraocular Implant to Timolol Maleate Ophthalmic Solution, 0.5%

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 18 Dec 2023

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At a glance

  • Drugs Travoprost (Primary) ; Timolol
  • Indications Ocular hypertension; Open-angle glaucoma
  • Focus Therapeutic Use
  • Sponsors Glaukos Corporation

    • Most Recent Events

    • 14 Dec 2023 According to a Glaukos Corporation media release, based on Phase 3 pivotal trials (GC-010 and GC-012), the U.S. Food and Drug Administration (FDA) approved its New Drug Application (NDA) for a single administration per eye of iDose TR (travoprost intracameral implant) 75 mcg, a prostaglandin analog indicated for the reduction of intraocular pressure (IOP) in patients with ocular hypertension (OHT) or open-angle glaucoma (OAG).
    • 27 Jun 2023 Dose of Travoprost intraocular implant is decreased from 78 to 75 mcg.
    • 05 May 2023 According to a Celanese media release, the company has received the Day 74 notification from the U.S. Food and Drug Administration (FDA) acknowledging the previously submitted New Drug Application (NDA) for iDose TR (travoprost intraocular implant) is sufficiently complete to permit a substantive review. The Prescription Drug User Fee Act (PDUFA) goal date for the completion of the FDA's review of the iDose TR NDA is set for December 22, 2023.
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