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    Home > Medical News > Latest Medical News > The first drug to treat uveitis-related macular edema!

    The first drug to treat uveitis-related macular edema!

    • Last Update: 2021-11-16
    • Source: Internet
    • Author: User
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    Bausch+Lomb and Clearside Biomedical recently announced that the U.
    S.
    Food and Drug Administration (FDA) has approved Xipere (triamcinolone acetonide ophthalmic suspension) for injection in the suprachoroidal space (SCS).
    Treats macular edema associated with uveitis (an inflammation of the eye)

    .

    It is worth mentioning that Xipere is the first product approved by the US FDA to be administered by suprachoroidal space (SCS) injection, and it is also the first to be approved for the treatment of uveitis-related macular edema
    .
    The SCS administration method aims to promote the targeted delivery of therapeutic drugs to the retina and choroid

    .

    Macular edema is the accumulation of fluid in the macula, causing swelling of the retina and distortion of vision.
    If left untreated, it may cause permanent vision loss

    .
    Xipere is designed to use the proprietary SCS Microinjector® technology developed by Clearside to treat macular edema associated with uveitis through suprachoroidal administration

    .
    Suprachoroidal administration is an innovative technology to provide eye treatments, which may help to more targeted delivery of therapeutic drugs to the retina and choroid

    .

    SCS Microinjector® technology provides a unique channel for the treatment of posterior ocular diseases that often threaten vision
    .
    It can provide targeted and zoned delivery, as well as a higher absorption ratio compared to intravitreal injection (IVT)

    .
    Targeted administration of SCS can also limit the exposure of corticosteroids to the anterior segment of the eye, potentially reducing the risk of certain adverse events, such as cataracts, increased intraocular pressure and deterioration of glaucoma, which are usually related to topical administration techniques

    .

    This approval is based on data from the Phase 3 clinical study PEACHTREE
    .
    The study is a randomized, blinded, sham-controlled study, enrolling 160 patients with macular edema associated with non-infectious uveitis, and comparing Xipere (administered once every 12 weeks) with a sham control

    .
    The results showed that the study met the primary endpoint and all key secondary endpoints and additional endpoints

    .

    The data showed that compared with sham controls, Xipere treatment resulted in statistically significant and clinically significant improvements in visual acuity in patients with non-infectious uveitis-related macular edema, and improvements in all anatomical sites of uveitis
    .
    In addition, in patients with active inflammation at baseline, more than two-thirds of Xipere-treated patients experienced relief of symptoms through three commonly used methods of inflammation measurement (vitreous opacity, anterior chamber cells, and anterior chamber flares)

    .
    The specific data for the primary endpoint are: at the 24th week of treatment, 47% of patients in the Xipere treatment group achieved an improvement of at least 15 letters in best corrected visual acuity (BCV) from baseline, and 16% in the sham control group.
    The data is statistical Significant difference in learning (p<0.
    001)

    .

    Xipere (triamcinolone acetonide eye drops) is used for suprachoroidal injection.
    This medicine is a patented eye drops of the corticosteroid triamcinolone acetonide.
    It is used for suprachoroidal injection to treat macular edema associated with uveitis

    .
    Clearside's patented technology is designed to deliver drugs to the suprachoroidal space between the choroid and the outer protective layer of the eye (called the sclera)

    .
    Suprachoroidal cavity injection can quickly and fully disperse the drug to the back of the eye, make the drug last longer, and minimize damage to the surrounding healthy eye parts, thereby potentially providing beneficial and sustained curative effects, and has a good Security

    .

    Uveitis is a group of ocular inflammatory diseases and one of the main causes of vision loss, affecting approximately 350,000 patients in the United States and more than 1 million patients worldwide
    .
    Approximately one-third of patients develop uveitis macular edema, which is the formation of fluid in the macula

    .
    Macular edema is the main cause of vision loss and blindness in patients with uveitis.
    It can be caused by uveitis that affects any anatomical location (anterior, middle, posterior, or pan)

    .
    The uveitis market is expected to grow to 550 million U.
    S.
    dollars in the United States by 2024, and to exceed 1 billion U.
    S.
    dollars globally

    .

    Note: The original text has been deleted

    Original source: Bausch + Lomb and Clearside Biomedical Announce FDA Approval of XIPERE™ (triamcinolone acetonide injectable suspension) for Suprachoroidal Use for the Treatment of Macular Edema Associated with Uveitis

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