Small molecule delivery with implantable therapeutic device

• US 10,166,142 B2
• Filed: 08/03/2012
• Issued: 01/01/2019
• Est. Priority Date: 01/29/2010
• Status: Active Grant

• Current Assignee: Forsight Vision4, Inc. (Roche Holding AG)
• Original Assignee: Forsight Vision4, Inc. (Roche Holding AG)
• Inventors: De Juan, Jr., Eugene, Alster, Yair, Farinas, Kathleen Cogan, MacFarlane, K. Angela, Reich, Cary J., Campbell, Randolph E., Erickson, Signe
• Primary Examiner(s): Lee, Brandy S
• Application Number:
  US14/236,863
• Publication Number:
  US 20140358125A1
• Time in Patent Office: 2,342 Days
• CPC Class Codes: A61F 2250/0031 made from both resorbable and non-resorbable prosthetic parts, e.g. adjacent parts
• CPC Class Codes: A61F 2250/0068 the pharmaceutical product being in a reservoir
• CPC Class Codes: A61F 9/0017 implantable in, or in contact with, the eye, e.g. ocular inserts
• CPC Class Codes: A61K 31/382 having six-membered rings, e.g. thioxanthenes thiothixene A61K31/496
• CPC Class Codes: A61K 31/407 condensed with other heterocyclic ring systems, e.g. ketorolac, physostigmine
• CPC Class Codes: A61K 31/519 ortho- or peri-condensed with heterocyclic rings
• CPC Class Codes: A61K 9/0051 Ocular inserts, ocular implants
• CPC Class Codes: F04C 2270/041 Controlled or regulated

Abstract

A therapeutic device that can release a therapeutic agent comprising a porous structure coupled to a container comprising a reservoir. The reservoir can comprise a volume sized to release therapeutic amounts of the therapeutic agent for an extended time when coupled to the porous structure and implanted in a patient. The porous structure may comprise a first side coupled to the reservoir and a second side to couple to the patient to release the therapeutic agent. The length of the channels extending from the first side to the second side may comprise an effective length greater than a distance across the porous structure from the first side to the second side. The therapeutic device may comprise a penetrable barrier to inject therapeutic agent into the device when implanted in the patient.

Claims

1. An implantable therapeutic device to treat an eye, the implantable therapeutic device comprising:

a refillable, reservoir chamber;

a retention structure comprising;

a narrow portion arranged to fit within an incision through the sclera of the eye, wherein the narrow portion has a cross-section taken perpendicular to a longitudinal axis of the device, the cross-section having a first distance across that is greater than a second distance across such that the cross-section of the narrow portion has an elongate shape compared to a shape of a cross-section of the reservoir chamber taken perpendicular to the longitudinal axis of the device; and

an extension between the narrow portion and a proximal end of the reservoir chamber;

a septum extending through the retention structure and at least a portion of the extension, the septum configured to be penetrated for filling the reservoir chamber from outside the eye; and

a rigid, porous structure formed of sintered particles and coupled to a distal end region of the reservoir chamber away from the retention structure,

wherein the porous structure and the reservoir chamber are tuned to release therapeutic amounts of a commercial formulation of a drug for an extended time compared to when the commercial formulation of the drug is applied directly to the eye, wherein the extended time is at least about one month,

wherein the reservoir chamber has a volume sized to contain the commercial formulation of the drug to provide the therapeutic amounts each day of the at least about one month,

wherein the drug is dorzolamide and the therapeutic amounts released each day of the at least about one month are within a range from about 1 ug/day to about 100 ug/day.

2. The device of claim 1, wherein the porous structure and the reservoir chamber are configured to release a substantially constant amount of dorzolamide within the range for at least about 90 days.

3. The device of claim 1, wherein a release rate index (RRI) of the device is within a range from about 0.002 to about 0.2.

4. The device of claim 1, wherein the volume of the reservoir chamber is within a range from about 10 uL to about 100 uL.

5. The device of claim 1, wherein the suspension is a dorzolamide suspension comprising an amount of dorzolamide within a range from about 30 ug to about 20 mg injected into the therapeutic device implanted in the eye or from about 1 mg to about 10 mg injected into the therapeutic device implanted in the eye.