Forehead Progesterone and Punctal Plugs for Ocular GVHD

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Solution Overview

Problem

Current transdermal delivery methods for medications, particularly for ocular graft-versus-host disease, are ineffective in alleviating inflammatory ocular symptoms, and existing ophthalmic solutions do not adequately address the severity of chronic ocular GVHD, leading to significant discomfort and potential vision loss.

Innovation Solution

A method involving topical administration of progesterone to the forehead, punctal plugs, and topical corticosteroid application to the eye, which includes using loteprednol etabonate ointment, to treat inflammatory ocular surface diseases and conditions, including ocular GVHD, by targeting cranial nerves for therapeutic effect.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If current transdermal delivery methods are used for delivering progesterone, then the drug can be delivered through the skin, but the delivery is ineffective for treating inflammatory ocular symptoms

Engineering Contradiction:
Improveeffectiveness of treatmentVSAvoiddelivery efficiency
Core Design Contradiction:
ReliabilityVSProductivity

Solution Approach 1:

The treatment is divided into multiple components: topical progesterone composition applied to the forehead, punctal plugs inserted into the eye, and topical corticosteroid composition applied to the eye. This segmentation allows each component to target specific pathways for treating ocular GVHD, with the progesterone affecting cranial nerves, the punctal plugs reducing tear drainage, and the corticosteroid directly reducing ocular inflammation.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent introduces intermediate mechanisms to enhance drug delivery and effectiveness. The punctal plugs act as intermediaries to modify tear film dynamics and prevent drug washout. The topical progesterone composition serves as an intermediary carrier to deliver progesterone to cranial nerves, which then exert their therapeutic effect on the ocular surface.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Reliability

If existing ophthalmic solutions are used to treat ocular GVHD, then treatment is applied directly to the eye, but the solutions are largely ineffective in alleviating chronic ocular symptoms

Engineering Contradiction:
Improvetherapeutic effectivenessVSAvoidtreatment efficacy
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The patent changes the parameters of the treatment by using a combination of different agents with different mechanisms of action. Instead of a single ophthalmic solution, the treatment combines topical progesterone (affecting cranial nerves), punctal plugs (modifying tear dynamics), and topical corticosteroids (reducing inflammation). This multi-parameter approach addresses the complexity of chronic ocular GVHD more effectively.

Inventive Principle:
Principle #35Parameter changes

3Reliability

If topical progesterone composition is administered to the forehead with punctal plugs and topical corticosteroid, then ocular surface health improves and symptoms reduce, but the treatment regimen becomes more complex

Engineering Contradiction:
Improveocular surface health improvementVSAvoidtreatment regimen complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent merges multiple treatment modalities into a unified regimen that addresses ocular GVHD comprehensively. The topical progesterone composition, punctal plugs, and topical corticosteroid composition are combined to work synergistically, with the progesterone affecting cranial nerves, the punctal plugs preventing tear drainage, and the corticosteroid reducing inflammation, thereby achieving better overall therapeutic effectiveness.

Inventive Principle:
Principle #5Merging (Combining)

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 combination significantly improves ocular surface health, reduces symptoms, and promotes healing, as demonstrated by improved visual acuity and reduced ocular surface inflammation in clinical trials, offering a more effective treatment for inflammatory ocular conditions compared to standard therapies.

Implementation Method 1

Transdermal methods allow for the delivery of medicine directly through the skin

Methodology Applied
Scientific EffectTransdermal delivery: Permeation

Implementation Method 2

administering a topocal corticosteroid composition to the eye of the subject

Methodology Applied
Scientific EffectAnti-inflammatory action:

Implementation Method 3

administering punctal plugs to the subject

Methodology Applied
Scientific EffectPhysical blockage:

Data Source

PatentUS20230091716A1Progesterone Combinations
Publication Date: 2023.03.23 GLIA LLC
  • US20230091716A1 patent drawing
  • US20230091716A1 patent drawing

AI summary

The present disclosure describes a method for treating or preventing an inflammatory ocular surface disease or disorder, such as ocular graft-versus-host disease, dry eye, meibomian gland disease, thyroid eye disease, blepharitis, Sjogren's syndrome, peripheral ulcerative keratitis, or Stevens-Johnson syndrome, in a human subject in need thereof, the method comprising (a) administering a topical progesterone composition to the forehead of the subject; (b) administering punctal plugs to the subject; and (c) administering a opical corticosteroid composition, such as loteprednol etabonate ointment, to the eye of the subject. Such administration methods may also be useful in improving corneal health before cataract surgery and/or promoting healing of the cornea after cataract surgery.