Bioerodible Ocular Insert Sustaining Vorolanib Release
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Solution Overview
Problem
Current treatments for wet age-related macular degeneration (AMD) are inconvenient, have significant adverse effects, and do not cure the disease, with no existing drugs to prevent its onset or progression, and there is a high risk of fellow eye conversion in patients with unilateral wet AMD.
Innovation Solution
A bioerodible ocular drug delivery insert containing vorolanib, administered intraocularly, provides sustained release of the drug to prevent wet AMD, choroidal neovascularization, and slow AMD progression, with a design that erodes within a specified period.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If existing treatments for wet AMD are used, then vision loss can be slowed, but the treatments are inconvenient and have significant adverse effects
Solution Approach 1:
The implantable drug delivery device is designed to automatically release anti-VEGF medication over an extended period without requiring patient intervention. The device self-regulates drug release through its biodegradable polymer matrix, eliminating the need for repeated manual injections while maintaining therapeutic effectiveness throughout the degradation cycle
Solution Approach 2:
The device is implanted once with a pre-loaded reservoir of anti-VEGF medication that will be released gradually over months. This preliminary loading of the drug reservoir eliminates the need for repeated subsequent injections, providing convenient long-term treatment while maintaining reliability
2Reliability
If existing treatments for wet AMD are used, then vision loss can be managed, but the treatments do not cure the disease and have significant adverse effects
Solution Approach 1:
The device delivers anti-VEGF medication directly to the site of choroidal neovascularization through a biodegradable polymer matrix implanted in the eye. This localized delivery concentrates the therapeutic effect at the target site while minimizing systemic absorption and associated adverse effects compared to intravitreal injections
Solution Approach 2:
The biodegradable polymer matrix provides continuous, sustained release of anti-VEGF medication over the course of its degradation (typically 3-6 months). This continuous therapeutic action maintains stable drug levels at the site of neovascularization, improving disease management reliability while reducing the frequency of dosing and associated adverse effects
3Reliability
If anti-VEGF therapy is administered to treat wet AMD in one eye, then vision loss in that eye can be prevented, but there is a significant risk of fellow eye conversion
Solution Approach 1:
The device is implanted with a pre-loaded reservoir of anti-VEGF medication that provides extended-duration therapy. This preliminary loading allows for prolonged suppression of VEGF activity in the treated eye, potentially preventing the development of choroidal neovascularization in the fellow eye by maintaining therapeutic levels over the entire degradation period
4Duration of action of moving object
If sustained release of API is provided for extended period, then therapeutic effectiveness is maintained, but the insert must be designed to erode within a specified period
Solution Approach 1:
The device utilizes biodegradable polymers with controlled molecular weights and degrees of hydrolysis to regulate erosion rate and drug release duration. By adjusting these material parameters, the device achieves sustained release over 3-6 months while controlling the degradation timeline to match therapeutic requirements
Solution Approach 2:
The device employs composite polymer matrices combining different biodegradable materials with specific degradation characteristics. This composite approach allows tuning of the erosion rate to match the desired drug release profile, achieving extended therapeutic action while controlling the timeline for complete device degradation
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The insert effectively prevents wet AMD, choroidal neovascularization, and slows AMD progression by maintaining therapeutic drug levels for up to 180 days with minimal systemic toxicity, reducing the risk of fellow eye conversion and maintaining visual acuity.
Implementation Method 1
a bioerodible ocular drug delivery insert comprising an active pharmaceutical ingredient (API) and a bioerodible polymer
Data Source
AI summary
This invention relates to a method for preventing, stabilizing or slowing progression of AMD in an eye in a human subject comprising administering to the eye an ocular drug delivery insert.