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Intraocular drug delivery device and associated methods

An eye and copolymer technology, applied in the field of ophthalmology, can solve problems such as poor drug permeability

Inactive Publication Date: 2019-10-15
UNIV OF UTAH RES FOUND
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Existing literature and experience show that drug penetration is poor after topical administration, while higher systemic concentrations imply frequent systemic adverse events

Method used

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  • Intraocular drug delivery device and associated methods
  • Intraocular drug delivery device and associated methods
  • Intraocular drug delivery device and associated methods

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0073] Standard clear phacoemulsification and intraocular lens (Acrysof SA60AT; Alcon) implantation were performed on 35 rabbits. At each surgery, an intraocular device containing the active agent was inserted into the lens capsule of each rabbit. Rabbits were divided into 4 groups according to the active agent in the intraocular device. The device is loaded with 5-15 mg of Avastin, Timolol, Brimonidine or Latanoprost. Each group was evaluated to determine intraocular device and lens stability, capsular fibrosis, and healing of the cataract wound and anterior segment. A subset of eyes were assessed weekly for inflammation for 4 weeks and harvested at 1 month for histopathological assessment of capsule and CDR integrity.

Embodiment 2

[0075] The procedure and setup described in Example 1 was repeated, except that aqueous humor and vitreous aspiration were performed biweekly, and drug concentrations were determined by HPLC and / or ELISA. In each drug group, half of the eyes were harvested at one month and the other half at two months. This was done as follows: Immediately after the rabbit was sacrificed and the eye was enucleated, the eye was frozen in liquid nitrogen to prevent perturbation and redistribution of the drug in the ocular tissue. Eyes were then sectioned in triplicate (aqueous humor, vitreous, and retina / choroid layers) to assess anatomic toxicity and tissue drug concentrations. Retrieve the intraocular device and assess the amount of remaining drug. Compare the distribution curve of intraocular device with 2.5mg / 0.1cc conventional intravitreal injections in order to directly compare different delivery methods.

[0076] At 2 and 4 months, rabbit eyes from the remaining subgroups were enuclea...

Embodiment 3

[0078] Following lens extraction (phacoemulsification), three intraocular devices were implanted in the eyes of New Zealand White rabbits under general anesthesia. Two of the devices were loaded with Avastin and one was loaded with the contrast agent Galbumin as a control. Proper intraocular device placement was verified by MRI and clinical examination.

[0079] Rabbits were sacrificed 1 week after implantation and eyes were removed and assayed. Avastin concentrations of 24-48mcg / mL were detected by ELISA in the retina and vitreous, but not in control rabbit eyes. Figure 5 The amount of Avastin measured for each eye area at 1 week post-implantation is shown.

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Abstract

Devices, systems, and methods for delivery of an active agent from the lens capsule to a posterior segment of the eye of a subject can include an intraocular active agent delivery device including anactive agent dispersed within a biodegradable active agent matrix. The active agent includes dexamethasone and the delivery device is adapted to fit within a lens capsule or ciliary sulcus of an eye.The delivery device can be inserted into the lens capsule or ciliary sulcus of an eye during cataract surgery or for treatment of uveitis.

Description

technical field [0001] The present invention relates to systems, methods and devices for the sustained and targeted (topical) delivery of pharmaceutically active agents into the eye of a subject. Accordingly, the present invention relates to the fields of polymer chemistry, materials science, polymer science, drug delivery, formulation science, pharmaceutical science and medicine, especially ophthalmology. Background technique [0002] Age-related macular degeneration (AMD) and glaucoma are the two leading causes of blindness in the United States and worldwide. Current glaucoma therapies often require polypharmacy, where subjects are often prescribed several topical agents that must be applied to the eye at varying frequencies, in some cases as many as 3 or 4 times per day. These dosing regimens are often difficult for subjects to follow consistently, and many individuals develop the need for surgery, such as intraocular shunt or trabeculectomy - with significant attendant ...

Claims

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Application Information

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IPC IPC(8): A61K31/573A61K9/00A61K9/20
CPCA61K9/0051A61K31/498A61K31/5377A61K31/5575A61K31/573A61P41/00A61K47/34A61K47/38A61L27/18A61L27/54A61L27/58A61L2400/06A61L2400/12A61L2430/16C07K16/22A61K2039/505C07K2317/24C07K2317/76C08L67/04A61F9/0017A61K9/0087A61K47/12A61K39/395A61K31/4709A61K31/196A61K31/407A61P27/02A61F2250/0067
Inventor B·K·阿姆霸提B·K·加勒S·R·彻纳马内尼
Owner UNIV OF UTAH RES FOUND
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