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Compositions and methods for improving the success of glaucoma surgery using nintedanib

A technology for nintedanib and glaucoma, applied in the field of improving the success rate of glaucoma surgery

Active Publication Date: 2022-03-04
BOYUN BIOMEDICAL TECH GUANGZHOU CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Current treatments for reducing failure are still inadequate and need improvement

Method used

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  • Compositions and methods for improving the success of glaucoma surgery using nintedanib
  • Compositions and methods for improving the success of glaucoma surgery using nintedanib
  • Compositions and methods for improving the success of glaucoma surgery using nintedanib

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0050] Embodiment 1: Rabbit glaucoma surgery model

[0051]A rabbit model of glaucoma surgery was used to demonstrate the success of glaucoma filtering surgery using the methods disclosed in the present invention. In particular, the established glaucoma filtration surgery model in rabbits was used to study the effect of 0.2% nintedanib solution on postoperative wound healing events. Surgical procedures were as described by Wong et al. (Wong et al., Invest Ophthalmol Vis Sci. 2003;44(3):1097-1103). Briefly, a partially torn 8-0 silk corneal traction suture was placed over and the eye was pulled down. The fornix-based conjunctival flap was lifted, after which blunt dissection of the subconjunctival space was performed approximately 5 mm along the limbus, and 8 mm posteriorly. A partially torn scleral incision was made 3 to 4 mm posterior to the limbus using a microretinal knife (MVR) and a scleral tunnel to the corneal stroma was created. A 22-gauge, 25-mm intravenous cannula...

Embodiment 2

[0056] Example 2: Nintedanib Topical Ophthalmic Preparation as Adjuvant Therapy for Glaucoma Filtration Surgery

[0057] In a clinical study, topical nintedanib 0.2% was administered as adjuvant therapy to increase the success of trabeculectomy. The effect of topical nintedanib 0.2% on the success rate of trabeculectomy was investigated in a randomized, double-blind, placebo-controlled, 12-month trial. The study design was as described by Vandewalle et al. (Vandewalle et al., Br J Ophthalmol. 2014, Jan;98(1):73-8).

[0058] Patients with medically uncontrolled open-angle glaucoma undergoing planned primary trabeculectomy will be enrolled and randomized to receive one drop of nintedanib three times daily or a placebo solution. Treatment starts immediately after surgery and will continue for 1 month. Approximately 150 patients were enrolled in this study.

[0059] Surgery will be performed by an experienced surgeon under general or retrobulbar anesthesia using a modified Moor...

Embodiment 3

[0064] Example 3: Formulation

[0065] Nintedanib Ophthalmic Solution

[0066] 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 1 for the composition of the ophthalmic solution.

[0067] Table 1 Nintedanib Ophthalmic Solution

[0068]

[0069]

[0070] Nintedanib Ophthalmic Suspension

[0071] 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 2.

[0072] Table 2 Nintedanib Ophthalmic Suspension

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Abstract

This application disclosed a composition and method that use Nidanbu to improve the success rate of glaucoma filtration surgery.Nidyb can be used alone or in the eye or implanted eye preparations or combined with anti -metabolic drugs.

Description

[0001] claim of priority [0002] This application claims the benefit of U.S. Provisional Patent Application Serial No. 62 / 344,878, filed June 02, 2016, and U.S. Provisional Patent Application Serial No. 62 / 344,870, filed June 02, 2016, each of which is incorporated by reference in its entirety incorporated into this application. technical field [0003] The present disclosure relates to ophthalmic compositions comprising nintedanib and methods of using the same to improve the success of glaucoma surgery. Background technique [0004] Glaucoma refers to a group of eye conditions that damage the optic nerve, usually caused by abnormally elevated intraocular pressure. One way to lower eye pressure in glaucoma is to have surgery to create drains in the eye. This type of surgery is called glaucoma filtering surgery (eg, trabeculectomy). During glaucoma surgery, a piece of tissue in the drainage corner of the eye is removed, creating the opening. This new opening forms a drai...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61F9/00A61F9/007
CPCA61K9/0048A61K31/496A61P27/06Y02A50/30A61K9/0051A61K45/06A61P41/00A61P27/02A61K31/365A61K31/404A61K31/407A61K31/416A61K31/4412A61K31/4439A61K31/444A61K31/4709A61K31/506A61K31/513A61K31/517A61K31/519A61K31/52A61K31/675A61K47/02A61K47/10A61K47/183A61K47/186A61K47/26A61K47/36A61K47/40A61K9/08A61K9/107
Inventor J.倪R.杨
Owner BOYUN BIOMEDICAL TECH GUANGZHOU CO LTD
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