APPARATUS AND FORMULATIONS FOR SUPRACHORIDAL DRUG DELIVERY

• US 20130245600A1
• Filed: 03/15/2013
• Published: 09/19/2013
• Est. Priority Date: 02/22/2006
• Status: Abandoned Application

• Current Assignee: Clearside Biomedical, Inc.
• Original Assignee: iScience Interventional Corporation
• Inventors: Yamamoto, Ronald, Conston, Stanley R., Sierra, David
• Application Number:
  US13/842,288
• Publication Number:
  US 20130245600A1
• Time in Patent Office: Days
• US Class Current: 604/506
• CPC Class Codes: A61F 9/0017 implantable in, or in contact with, the eye, e.g. ocular inserts
• CPC Class Codes: A61F 9/0026 Ophthalmic product dispenser attachments to facilitate positioning near the eye
• CPC Class Codes: A61F 9/007 Methods or devices for eye surgery
• CPC Class Codes: A61F 9/00736 Instruments for removal of intra-ocular material or intra-ocular injection, e.g. cataract instruments A61F9/008 takes precedence
• CPC Class Codes: A61K 31/717 Celluloses
• CPC Class Codes: A61K 31/718 Starch or degraded starch, e.g. amylose, amylopectin
• CPC Class Codes: A61K 31/722 Chitin, chitosan
• CPC Class Codes: A61K 31/728 Hyaluronic acid
• CPC Class Codes: A61K 31/737 Sulfated polysaccharides, e.g. chondroitin sulfate, dermatan sulfate A61K31/727 takes precedence
• CPC Class Codes: A61K 47/36 Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
• CPC Class Codes: A61K 9/0048 Eye, e.g. artificial tears
• CPC Class Codes: A61K 9/0051 Ocular inserts, ocular implants
• CPC Class Codes: A61K 9/14 Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles microspheres A61K9/16; microcapsules A61K9/50; nanocapsules, nanoparticles of the matrix type A61K9/51
• CPC Class Codes: A61K 9/1635 obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
• CPC Class Codes: A61M 2005/3103 Leak prevention means for distal end of syringes, i.e. syringe end for mounting a needle
• CPC Class Codes: A61M 2210/0612 Eyes
• CPC Class Codes: A61M 5/486 Indicating injection pressure

Abstract

Drug formulations, devices and methods are provided to deliver biologically active substances to the eye. The formulations are delivered into scleral tissues adjacent to or into the suprachoroidal space without damage to the underlying choroid. One class of formulations is provided wherein the formulation is localized in the suprachoroidal space near the region into which it is administered. Another class of formulations is provided wherein the formulation can migrate to another region of the suprachoroidal space, thus allowing an injection in the anterior region of the eye in order to treat the posterior region.

Claims

1. A method of administering drugs in the suprachoroidal space of the eye comprising the steps of placing a needle in scleral tissues toward the suprachoroidal space at a depth of at least half of the scleral thickness, and injecting a drug formulation through said needle into the sclera in close proximity to the inner boundary of the sclera such that said formulation dissects the scleral tissues adjacent to said suprachoroidal space and enters said suprachoroidal space.

7. The method according to any one of claim 1, 2, or 4 wherein the placing of the needle tip is guided by imaging surrounding tissues.

8. The method according to any one of claim 1, 2, or 4 wherein said needle comprises a sensor to guide the placement of the needle tip.

2. A method of administering drugs in the suprachoroidal space of the eye comprising the steps of placing a needle in scleral tissues toward the suprachoroidal space at a depth of at least half of the scleral thickness, and injecting a drug formulation through said needle into the sclera such that said formulation dissects the scleral tissues adjacent to said suprachoroidal space to enter said suprachoroidal space and flows toward the posterior region of said suprachoroidal space.

3. A method for administering drugs to an eye comprising:

injection of a drug formulation into the suprachoroidal space,

said drug formulation comprising a biologically active substance and a polymer excipient, wherein the drug formulation forms a layer between the choroid and sclera in the area of administration.

4. The method according to claim 3, wherein said injection comprises injection through a needle.

5. The method according to claim 3, wherein said biologically active substance comprises a steroid or non-steroidal anti-inflammatory agent to treat inflammation and edema.

6. The method according to claim 3 wherein said polymer excipient comprises a water soluble polymer.

9. A method for administering drugs to an eye comprising:

injection of a drug formulation into the suprachoroidal space,

said drug formulation comprising microspheres or microparticles with an outer diameter in the range of about 1 to 33 microns, and a polymer excipient,

wherein said microspheres or microparticles comprising a biologically active substance, wherein said polymer excipient acts to uniformly distribute the microspheres or microparticles administered to the suprachoroidal space.

10. A method for administering drugs to an eye comprising:

injection of a drug formulation into the suprachoroidal space,

said drug formulation comprising microspheres or microparticles with an outer diameter in the range of about 1 to 33 microns;

wherein said microspheres or microparticles comprise a biologically active substance,

wherein said microspheres or microparticles subsequently migrate posteriorly to treat a posterior region distant from the injection site.

11. The method according to 10 wherein said drug formulation additionally comprises a polymer excipient.