Enhanced (T)EW-7197 Compositions and Methods for Treating Corneal Endothelial Diseases
Legal Citation
Summary of the Inventive Concept
The present inventive concept relates to novel compositions and methods utilizing (T)EW-7197 for treating or preventing corneal endothelial diseases, providing improved efficacy, safety, and convenience.
Background and Problem Solved
The original patent disclosed the use of (T)EW-7197 for treating or preventing corneal endothelial diseases. However, the existing patent has limitations, such as high dosages, short residence time, and lack of targeted administration. The present inventive concept addresses these limitations by introducing novel compositions and methods that enhance the therapeutic effect of (T)EW-7197 while reducing its required dosage.
Detailed Description of the Inventive Concept
The inventive concept comprises four main aspects: 1) a system for targeted administration of (T)EW-7197 to the corneal endothelium using a nano-particle delivery system, reducing the required dosage by at least 50%; 2) a method for combining (T)EW-7197 with a ROCK inhibitor to enhance the therapeutic effect by at least 20%; 3) a pharmaceutical composition incorporating (T)EW-7197 and a mucoadhesive polymer to increase the residence time in the corneal endothelium by at least 2 hours; and 4) a sustained-release formulation of (T)EW-7197 maintaining a therapeutic concentration for at least 7 days. Additionally, a temperature-controlled storage device is provided to enhance the stability of the (T)EW-7197 composition.
Novelty and Inventive Step
The present inventive concept is novel and non-obvious over the original patent as it introduces new compositions and methods that significantly improve the efficacy, safety, and convenience of (T)EW-7197 treatment. The use of nano-particle delivery systems, ROCK inhibitors, mucoadhesive polymers, sustained-release formulations, and temperature-controlled storage devices are all new and unobvious features that overcome the limitations of the original patent.
Alternative Embodiments and Variations
Alternative embodiments of the inventive concept may include different nano-particle delivery systems, ROCK inhibitors, or mucoadhesive polymers. Variations of the sustained-release formulation may include different polymers or release profiles. Additionally, the temperature-controlled storage device may be replaced with other stabilization methods.
Potential Commercial Applications and Market
The present inventive concept has significant commercial potential in the ophthalmic industry, particularly for the treatment of corneal endothelial diseases such as Fuchs' endothelial corneal dystrophy and corneal guttata. The improved efficacy, safety, and convenience of the novel compositions and methods are expected to attract significant market share and revenue.
Section 103 Obviousness Analysis (PHOSITA)
Field of Art
Pharmaceutical compositions and methods for treating corneal endothelial diseases, specifically involving targeted drug delivery and formulation techniques in ophthalmology
Person of Ordinary Skill (PHOSITA) Profile
A pharmaceutical scientist or medical researcher with expertise in drug delivery systems, ophthalmological treatments, and formulation technologies, holding at least a PhD or equivalent professional experience in pharmaceutical development
Obviousness Rationale
A person having ordinary skill in the art would recognize that the PTD's variations represent predictable extensions of the source patent's core compound and treatment method. The proposed delivery enhancements and combination strategies are logical progressions in pharmaceutical development, addressing known limitations in drug administration and efficacy. These modifications represent standard optimization techniques routinely employed by skilled practitioners to improve therapeutic outcomes.
Obvious Combinations & Variations
Original Patent Information
| Patent Number | US 11,857,544 |
|---|---|
| Title | Composition or method including (t)ew-7197 for treating or preventing corneal endothelial diseases |
| Assignee(s) | SENJU PHARMACEUTICAL CO., LTD., THE DOSHISHA |