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TLC399 applies sustained release technology for the treatment of macular edema secondary to retinal vein occlusion (RVO), designed to provide benefits for a much longer duration than existing therapies and to thus reduce the administration frequency. |
TLC399 applies TLC’s BioSeizer® technology to allow sustained release of the corticosteroid dexamethasone and is designed to provide effects lasting as long as six months between injections. |
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TLC399 is our proprietary BioSeizer® formulation of dexamethasone sodium phosphate (DSP), intended as an intravitreal, or in-eye, injection for the treatment of macular edema due to retinal vein occlusion. TLC399 in preclinical models has been shown to provide therapeutic levels of DSP in the eye for at least six months after a single administration. A Phase I/II safety trial has demonstrated encouraging signs of efficacy in both the reduction of retinal central subfield thickness and improvements in visual acuity. A larger randomized, double-blind, dose finding Phase II trial is underway. We are also evaluating opportunities to develop TLC399 in diabetic macular edema in combination with intravitreal anti-VEGF drugs. |
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API Dexamethasone sodium phosphate |
DDS Platform |
Indication Macular edema |
Advantages
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Development Status Phase II |