Compositions and methods for treating pterygium

A technology of pterygium and implant, applied in the field of compositions and methods for treating pterygium, capable of solving problems such as visual impairment

Active Publication Date: 2018-06-08
BOYUN BIOMEDICAL TECH GUANGZHOU CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Patients with pterygium often experience ocular discomfort, symptoms of congestion and are at risk of visual impairment if the lesion invades the visual axis

Method used

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  • Compositions and methods for treating pterygium
  • Compositions and methods for treating pterygium
  • Compositions and methods for treating pterygium

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0085] Example 1: Rabbit corneal suture model of neovascularization and hyperemia

[0086] Establish a rabbit corneal suture model to evaluate the effect of drugs on corneal neovascularization (Ko et al., Cornea.2013; 32(5):689-695; Pérez-Santonja et al., Am J Ophthalmol.2010;150(4):519 -528). The anti-angiogenic activity of nintedanib was investigated in this model.

[0087] Topical Ophthalmic Preparations

[0088] Topical compositions were prepared comprising 0.2% or 0.05% nintedanib in phosphate buffered saline (pH 7.4) containing 10% 2-hydroxypropyl beta cyclodextrin. In addition, a composition containing 0.05% sunitinib was prepared in the same vehicle as a positive control.

[0089] Animals and Treatment Procedures

[0090]Thirty-six female New Zealand White rabbits were used for the study. Briefly, five sutures were placed in the superior cornea of ​​the right eye of each animal on day 1 to induce neovascularization. Both eyes of the animals were treated as de...

Embodiment 2

[0107] Embodiment 2: human pterygium mouse model

[0108] A mouse model of human pterygium was described to assess the growth of human pterygium on the cornea of ​​immunodeficient mice (Lee et al., Graefes Arch Clin Exp Ophthalmol. 2014;252(4):609-18). This study examined the effect of several drugs on the growth of pterygium. The drugs were nintedanib, sunitinib, and mitomycin C.

[0109] Topical Ophthalmic Preparations

[0110] The analytes were prepared in phosphate buffered saline (pH 7.4) containing 10% 2-hydroxypropyl beta-cyclodextrin. Details of the formulations are disclosed in the following sections.

[0111] animal

[0112] Seven-week-old male athymic nude mice were acclimatized in filter-top closed cages under pathogen-free conditions.

[0113] Human pterygium primary cell culture

[0114] Human pterygium epithelial cells (hPEC) were isolated from specimens collected after surgical resection and cultured. All participants provided written informed cons...

Embodiment 3

[0135] Example 3: Formulation

[0136] Nintedanib Ophthalmic Solution

[0137] The drug product is an isotonic ophthalmic solution prepared in 2-hydroxypropyl beta-cyclodextrin or other similar cyclodextrin and a buffered solution (pH range from 5.5 to 8.0). Other viscosity builders, lubricants, preservatives may be added to enhance the functionality of the formulation. See Table 6 for the composition of the ophthalmic solution.

[0138] Table 6: Nintedanib Ophthalmic Solution

[0139]

[0140]

[0141] Nintedanib Ophthalmic Suspension

[0142] The drug product is an isotonic ophthalmic suspension prepared in sodium carboxymethylcellulose and buffer solution (pH range from 5.5 to 8.0). The drug particle size is reduced to less than 40 microns. Other viscosifiers, lubricants, solubilizers and preservatives may be added to enhance the functionality of the formulation suspension. The composition is shown in Table 7.

[0143] Table 7: Nintedanib Ophthalmic Suspension ...

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Abstract

Compositions and methods for inducing pterygium regression from visual axis / central cornea, stabilizing pterygium, treating hyperemia and symptoms in pterygium patients, and treating pterygium recurrence following pterygiectomy are disclosed. The methods include administration of a multikinase inhibitor, an antimetabolite or a combination thereof to patients in need thereof.

Description

[0001] claim of priority [0002] This application claims the benefit of U.S. Provisional Patent Application Serial No. 62 / 172,063, filed June 6, 2015, and U.S. Provisional Patent Application Serial No. 62 / 186,660, filed June 30, 2015, each of which is incorporated by reference in its entirety incorporated into this application. technical field [0003] The present disclosure relates to ophthalmic compositions and methods for treating primary and recurrent pterygium, and more particularly to methods for inducing pterygium prior to, concurrently with, or following pterygium surgery. Compositions and methods for regression of pterygium from visual axis / central cornea, stabilization of pterygium, reduction of ocular hyperemia and recurrence of pterygium. Background technique [0004] Pterygium is a disorder of the ocular surface in which abnormal epithelial and fibroblast growth extends from the nasal or temporal conjunctiva across the corneal limbus and onto the cornea. Pati...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61F9/00A61K38/45A61K39/395C12N9/12
CPCA61K45/00A61K9/08A61K31/404A61K9/06A61K9/107A61K31/407A61K31/496A61K9/10A61K9/0051A61P27/02A61P27/00A61K9/0048A61K47/34A61F9/0017A61F2210/0004A61K2300/00A61F9/00A61K45/06A61K47/26A61K31/403
Inventor J.倪
Owner BOYUN BIOMEDICAL TECH GUANGZHOU CO LTD
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