Botulinum Toxin Extra-ocular Injection 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 invasive, costly, and associated with complications like intra-ocular hemorrhage, infections, and vision loss due to the need for frequent injections and potential damage to ocular structures.

Innovation Solution

Administration of botulinum toxin-based pharmaceuticals via intra-ocular or extra-ocular routes, including subcutaneous, sub-muscular, topical, and intraosseous injections, which penetrate the orbit and macula without weakening extra-ocular muscles, thereby avoiding complications like diplopia and ptosis, and can be repeated to maintain biologic effect.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If intra-ocular injections of anti-VEGF agents are administered frequently, then treatment efficacy for macular degeneration is improved, but risk of complications (intra-ocular hemorrhage, infections, vision loss) increases

Engineering Contradiction:

Improvetreatment efficacyVSAvoidcomplications (intra-ocular hemorrhage, infections, vision loss)

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent uses botulinum toxin as an intermediary substance administered via extra-ocular injection that indirectly treats macular degeneration by blocking nerve signals to choroidal vessels, reducing VEGF-mediated leakage and neovascularization without requiring direct intra-ocular injection, thus avoiding associated complications

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent replaces the mechanical/invasive intra-ocular injection system with a non-invasive extra-ocular injection system that delivers botulinum toxin to achieve therapeutic effects through neural and vascular mechanisms rather than direct ocular delivery

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

2Reliability

If intra-ocular injections are administered, then direct treatment of macular degeneration is achieved, but risk of damage to ocular structures and need for frequent invasive procedures increases

Engineering Contradiction:

Improvedirect treatment effectVSAvoidinvasiveness and frequency of procedures

Core Design Contradiction:

ReliabilityVSEase of operation

Solution Approach 1:

The patent inverts the conventional approach by administering the treatment extra-ocularly rather than intra-ocularly, using botulinum toxin injected into periorbital muscles or surrounding tissues to achieve indirect treatment of macular degeneration through neural and vascular mechanisms

Inventive Principle:

Principle #13The other way round (Inversion)

3Ease of operation

If botulinum toxin is injected into extra-ocular muscles, then direct muscle weakness occurs, but this can be avoided by precise injection pathways

Engineering Contradiction:

Improvesimpler injection routeVSAvoidavoidance of diplopia and ptosis

Core Design Contradiction:

Ease of operationVSReliability

Solution Approach 1:

The patent applies local quality by injecting botulinum toxin into specific periorbital muscles (orbicularis oculi, corrugator supercilii, procerus) at controlled doses that produce localized cosmetic effects without affecting extra-ocular muscles responsible for eye movement and eyelid function, thereby avoiding diplopia and ptosis

Inventive Principle:

Principle #3Local quality

Solution Approach 2:

The patent uses partial action by administering sub-therapeutic or controlled doses of botulinum toxin to extra-ocular muscles that are sufficient for cosmetic purposes and indirect macular degeneration treatment without exceeding the threshold that would cause harmful neuromuscular effects

Inventive Principle:

Principle #16Partial or excessive action

Data Source

PatentUS11096993B2Method of treating macular degeneration using botulinum toxin-based pharmaceuticals

Publication Date: 2021.08.24 BORODIC GARY E

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. 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 then be transported to the intra-ocular region of the patient, allowing the active ingredient(s) to penetrate into the choroid, neuro-retina, and/or retinal pigment epithelium without direct injection into the eye, eliminating risk of retinal detachment, retinal break, retinal hemorrhage, and blindness. The methods described herein allow for increased blood flow to the choroid, which improves removal of metabolites and intra retinal fluid and also serves to arrest, reverse and/or delay early and later stages of age-related macular degeneration.