Intravitreal Sirolimus for Persistent Edema in Wet AMD
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Solution Overview
Problem
Current treatments for wet age-related macular degeneration with intravitreal anti-vascular endothelial growth factor agents often fail to achieve significant anatomic flattening of the macula, leading to persistent intraretinal and subretinal edema, which results in poorer visual outcomes and the need for frequent retreatments.
Innovation Solution
Administering an intravitreal sirolimus formulation, either alone or in combination with an anti-VEGF agent, to patients with persistent edema due to exudative age-related macular degeneration, where previous anti-VEGF treatment has been inadequate, to reduce edema and improve visual acuity.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If intravitreal anti-VEGF agents are administered to treat wet AMD, then choroidal neovascularization is inhibited, but persistent intraretinal and subretinal edema remains
Solution Approach 1:
The patent combines anti-VEGF therapy with sirolimus treatment to address both neovascularization and edema simultaneously. Sirolimus targets the mTOR pathway which is involved in fluid transport and edema formation, complementing the anti-VEGF mechanism and providing synergistic effects for treating wet AMD with persistent edema.
Solution Approach 2:
The patent introduces a new pharmacological parameter (sirolimus concentration in the intravitreal formulation) to change the treatment approach. By administering sirolimus at specific concentrations (e.g., 0.1-10 μg/mL) via intravitreal injection, the treatment addresses edema through a different biochemical pathway than anti-VEGF agents alone.
2Reliability
If frequent retreatment with anti-VEGF agents is performed to stabilize vision, then visual acuity is maintained, but treatment complexity and patient burden increase
Solution Approach 1:
The patent aims to achieve more sustained edema reduction with sirolimus, potentially extending the interval between treatments. By targeting the mTOR pathway which regulates fluid transport and cellular metabolism, sirolimus may provide longer-lasting effects compared to anti-VEGF monotherapy, reducing the frequency of retreatment needed.
3Reliability
If anti-VEGF treatment is continued monthly, then neovascularization is controlled, but anatomic flattening of the macula is not achieved
Solution Approach 1:
The patent changes the therapeutic parameter by introducing sirolimus which acts on the mTOR pathway, a key regulator of fluid transport and cellular metabolism. This different mechanism of action targets the underlying causes of persistent edema and macular thickening, potentially achieving anatomic flattening that anti-VEGF therapy alone cannot accomplish.
Data Source
AI summary
This invention relates to a method for treatment of persistent edema in patients with exudative age-related macular degeneration. In particular, the present invention relates to treatment of wet age-related macular degeneration with intravitreal sirolimus in subjects that had an inadequate response to prior treatment with an intravitreal anti-vascular endothelial growth factor agent.