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FDA Approves IDose TR For Glaucoma, Ocular Hypertension

December 15, 2023

1 min read

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  • The FDA approved iDose TR for the treatment of open-angle glaucoma and ocular hypertension.
  • Commercial launch activities for the implant are anticipated to begin in the first quarter of 2024.

    • The FDA approved the iDose TR for the lowering of IOP in patients with ocular hypertension or open-angle glaucoma, according to a press release from Glaukos.

    "The glaucoma community has struggled with the limitations of topical drug delivery, such as nonadherence and burdensome side effects," Jay Katz, MD, FACS, chief medical officer at Glaukos, told Healio. "Intracameral placement of iDose TR provides ophthalmologists a long anticipated, welcome option that can be offered to patients which addresses noncompliance and side effect concerns."

    Generic FDA News infographic The FDA approved the iDose TR for the lowering of IOP in patients with ocular hypertension or open-angle glaucoma, according to a press release from Glaukos.

    The iDose TR (travoprost intracameral implant) 75 mcg is "designed to continuously deliver 24/7 therapeutic levels of a proprietary formulation of travoprost inside the eye for extended periods of time" to address issues with patient compliance and side effects caused by topical glaucoma treatments, according to the release.

    Jay Katz, MD, FACS

    Jay Katz

    The implant previously demonstrated positive results in the phase 3 GC-010 and GC-012 trials, which randomized 1,150 patients with open-angle glaucoma or ocular hypertension to treatment with either iDose TR or topical timolol ophthalmic solution, 0.5% twice daily.

    At 12 months, 81% of patients treated with iDose TR were free of topical medications across both trials, with 98% of patients continuing in the trial compared with 95% of those treated with timolol. The implant was well tolerated and demonstrated favorable safety results across both phase 3 trials, as well as additional controlled studies, where the most common ocular adverse reactions (2% to 6%) were increases in IOP, iritis, dry eye and visual field defects, "most of which were mild and transient in nature," according to the release.

    Glaukos plans to initiate the commercial launch of iDose TR in the first quarter of 2024.

    Editor's note: This article was updated on Dec. 15, 2023, to include comments from the chief medical officer of Glaukos.

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    Omlonti Approved For Open-Angle Glaucoma, Ocular Hypertension

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    Sagent Announces Launch Of Travoprost Ophthalmic Solution, USP

    Travoprost represents the first ophthalmic solution in Sagent's growing product portfolio

    SCHAUMBURG, Ill., Sept. 15, 2025 /PRNewswire/ -- Sagent Pharmaceuticals ("Sagent"), a leading provider of pharmaceuticals to the US market, today announced its entry into the ophthalmic market and launch of Travoprost Ophthalmic Solution, USP 0.004%. Travoprost is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension and represents a $61 million market in the 12 months ended July 2025.

    Sagent Pharmaceuticals Logo (PRNewsfoto/Sagent Pharmaceuticals)

    Travoprost is the first ophthalmic product offering in Sagent's portfolio and will be followed by more products in the coming year. According to IQVIA, the combined total addressable ophthalmic market is expected to exceed $8.6 billion. Sagent is strategically positioned to meet the growing demand for high-quality, accessible eye care treatments throughout the U.S. With these product launches, Sagent will enhance access, reduce treatment costs, and strengthen supply resilience for these critical medications.

    "Expanding into the ophthalmic space marks a significant step in broadening our portfolio and reinforcing our trajectory of sustainable growth." said Dr. Vishy Chebrol, CEO of Sagent. "We remain guided by our mission to improve patient outcomes, while leveraging our proven strengths in quality and reliability to ensure dependable access and long-term value."

    About Sagent PharmaceuticalsSagent Pharmaceuticals, founded in 2006, is a leading provider of generic and specialty pharmaceuticals. Sagent's portfolio of over 100 products offers flexibility across diverse therapeutic categories, formulations and packaging configurations including vials, syringes, premix bags and ophthalmic solutions. Sagent's global network of partners with rapid development capabilities, sophisticated manufacturing and innovative drug delivery technologies, enables its extensive and rapidly expanding pharmaceutical product portfolio, fulfilling the evolving needs of patients.

    Discover Injectables Excellence ®: visit www.Sagentpharma.Com.

    MEDIA CONTACT:Sagent PharmaceuticalsJeff GreveEVP, Chief Financial Officer(312) 331-0050jgreve@sagentpharma.Com

    Cision

    View original content to download multimedia:https://www.Prnewswire.Com/news-releases/sagent-announces-launch-of-travoprost-ophthalmic-solution-usp-302555682.Html





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