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    TLC399

    Dexamethasone sodium phosphate extended-release injectable suspension

    Description

    Long lasting implant-free ocular injection

    Development Status

    Phase 2 complete

    Advantages

    • Potential best-in-class of corticosteroids for eye diseases
    • High potency API
    • Patented formulation providing immediate onset and >6-month duration
    • No implant, smaller needle size reducing risk of conjunctival hemorrhaging & infections
  • Overview
  • Overview

    Understanding macular edema due to retinal vein occlusion (RVO)

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    Macular edema, a condition characterized by swelling in the central part of the retina (the macula), can significantly impair vision. This swelling is often caused by fluid leakage from retinal blood vessels, a common consequence of retinal vein occlusion (RVO). RVO occurs when one of the veins responsible for draining blood from the retina becomes blocked, leading to increased pressure in the capillaries. This pressure causes fluid and blood to leak into the retina, resulting in macular edema. There are two primary types of RVO: branch retinal vein occlusion (BRVO), which affects smaller branches of the retinal vein, and central retinal vein occlusion (CRVO), which impacts the main retinal vein.


    It is estimated that macular edema associated with retinal vein occlusion affects 16 million individuals globally. Patients with macular edema due to RVO may experience symptoms such as blurred or distorted vision, dark spots or floaters, and in severe cases, a sudden loss of vision. Diagnosis typically involves a comprehensive eye examination, including imaging tests like optical coherence tomography (OCT) and fluorescein angiography.

    Current treatment options

    The standard treatments for macular edema due to RVO involve intravitreal injections, which are administered directly into the eye to reduce swelling and improve vision. These treatments include:

    • Anti-VEGF Therapy: Drugs like ranibizumab (Lucentis) and aflibercept (Eylea) inhibit the growth of abnormal blood vessels and reduce fluid leakage. While effective, some patients may not respond adequately to anti-VEGF therapy.
    • Steroid Injections: Corticosteroids such as dexamethasone are used to reduce inflammation and swelling. Dexamethasone implants provide relief for 1-3 months, but repeated injections may be necessary, with potential side effects including increased intraocular pressure and cataract formation.
    • Laser Therapy: In certain cases, laser photocoagulation is used to seal leaking blood vessels and reduce macular edema. Although less commonly used now due to the effectiveness of intravitreal injections, it remains an option for some patients.
    • Combination Therapy: For patients who do not respond well to monotherapy, a combination of anti-VEGF and steroid injections may be utilized to achieve better results.

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    Advantages of TLC399

    TLC399 offers a significant advancement in the treatment of macular edema due to RVO. Utilizing our proprietary BioSeizer® technology, TLC399 encapsulates dexamethasone sodium phosphate (DSP) within multi-layered lipid membranes. This innovative delivery system provides an extended-release profile, maintaining therapeutic levels in the eye for at least six months following a single administration. This extended duration reduces the frequency of injections, improving patient compliance and quality of life.


    Clinical trials have demonstrated that TLC399 is well-tolerated, with no dose-limiting toxicities observed. The absence of significant adverse events related to the treatment makes TLC399 a promising option for the long-term management of macular edema.

    Indication

    Preclinical
    Phase 1
    Phase 2
    Phase 3
    NDA
    Market

    Macular edema

    Phase 2 complete