Botulinum Toxin Extraocular Delivery for Macular Degeneration
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Solution Overview
Problem
Current treatments for macular degeneration, such as intra-ocular injections of anti-VEGF agents, are associated with complications like intra-ocular hemorrhage, infections, and frequent injections, which can be painful and lead to vision loss, highlighting the need for a safer and more effective method to treat and prevent visual loss from this condition.
Innovation Solution
The use of botulinum toxin-based pharmaceuticals, administered intra-ocularly or extra-ocularly, which can penetrate the eye through axoplasmic transport without causing neuromuscular effects, targeting tissues like the choroid, neuro-retina, and retinal pigment epithelium to treat and prevent macular degeneration, including both exudative and non-exudative forms, by reducing leakage, neovascularization, and preserving photoreceptors.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If intra-ocular injections of anti-VEGF agents are administered to treat macular degeneration, then leakage and neovascularization are reduced, but complications such as intra-ocular hemorrhage, infections, and pain increase
Solution Approach 1:
The patent uses botulinum toxin as an intermediary substance that blocks the release of VEGF and other inflammatory mediators from retinal neurons and glial cells. This indirect mechanism prevents leakage and neovascularization without requiring direct injection of anti-VEGF agents into the eye, thereby reducing complications while maintaining treatment effectiveness
Solution Approach 2:
The patent replaces the mechanical injection method (intra-ocular needle injection) with a pharmacological approach using botulinum toxin. This substitution eliminates the physical trauma, hemorrhage risk, and infection risk associated with repeated needle injections while achieving the same therapeutic goal of reducing VEGF-mediated pathology
2Duration of action of stationary object
If frequent intra-ocular injections are administered to maintain therapeutic effect, then disease progression is controlled, but patient pain and risk of vision loss from complications increase
Solution Approach 1:
The patent introduces a dynamic, adjustable dosing regimen where botulinum toxin is administered at variable intervals based on individual patient response and disease severity. This allows optimization of therapeutic duration while minimizing the frequency of administrations, thereby improving patient convenience and reducing cumulative risk
Solution Approach 2:
The patent employs preliminary assessment of disease severity and progression rate to determine the optimal dosing interval for each patient. By predicting the duration of therapeutic effect based on baseline characteristics, the treatment plan can be customized to maintain efficacy while reducing the total number of injections required
3Object-affected harmful factors
If botulinum toxin is administered extra-ocularly to avoid intra-ocular complications, then safety is improved, but delivery precision to target tissues may be reduced
Solution Approach 1:
The patent utilizes the eye's own physiological mechanisms (axoplasmic flow in retinal neurons and vascular transport) to deliver botulinum toxin from extra-ocular injection sites to intra-ocular target tissues. This self-service delivery system leverages natural biological transport pathways to achieve precise tissue targeting without requiring precise needle placement or surgical intervention
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
This approach potentially delays degeneration, preserves vision, and reduces the frequency and risk of injections, offering a safer and more convenient treatment option by enhancing the duration of action and reducing complications associated with traditional methods.
Implementation Method 1
which can penetrate the eye through axoplasmic transport without causing neuromuscular effects
Data Source
AI summary
Formulations and methods of treatment are disclosed for prevention and/or treatment of visual loss from age-related macular degeneration. The disclosed formulations include botulinum neurotoxin (e.g., botulinum neurotoxin or a fragment thereof, either in pure form or with one or more peptide fragments and/or neurotoxin associated proteins). In some embodiments, the disclosed formulations also include one or more anti-VEGF agents. The disclosed formulations may be applied to an intraocular or extraocular region of a patient. If applied to an extra ocular region of a patient, the botulinum-based pharmaceutical formulation may be transported to the intra-ocular region of the patient via axoplasmic transport, thereby allowing the active ingredient(s) to penetrate into the choroid, neuro-retina, and/or retinal pigment epithelium without direct injection into the eye, allowing for improved therapeutic safety by eliminating risk of retinal detachment, retinal break, retinal hemorrhage, and blindness associated with direct injection into the eye.