Intraocular drug delivery systems and methods of use
Inventors
Cable, II, Craig Alan • Kahook, Malik Y. • Absalonson, Ryan • Sussman, Glenn R.
Assignees
University of Colorado Boulder • University of Colorado Colorado Springs • Spyglass Pharma Inc
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Publication Number
US-12193972-B2
Publication Date
2025-01-14
Expiration Date
Abstract
Embodiments of the instant disclosure relate to intraocular drug delivery devices for and methods of, delivering at least one therapeutic agent to an eye of a subject. Methods include implanting an intraocular implant into the eye and adjacent to a fluid-permeable membrane of the eye of the patient. Intraocular implants are supported in a position at a surface of the fluid-permeable membrane. Intraocular implants include a drug delivery component having at least one therapeutic agent embedded within a non-bioerodible, non-biodegradable polymer matrix. Devices and methods disclosed herein can further include delivering the at least one therapeutic agent to the eye of the subject according to a near zero-order elution rate of the at least one therapeutic agent.
Core Innovation
The invention relates to an intraocular implant for implantation within an eye of a subject. The implant comprises an implant body including a scaffold and at least one haptic extending outwardly from the scaffold, where the at least one haptic is configured to support a position of the implant body within the eye. A drug delivery component is configured to couple to the implant body.
The drug delivery component comprises a core and a solid non-bioerodible membrane fully encapsulating the core. The core comprises at least one therapeutic agent embedded within a biocompatible, non-bioerodible polymer, and the solid non-bioerodible membrane is configured to permit and control a rate of elution of the at least one therapeutic agent from the core through the solid non-bioerodible membrane by diffusion.
The document further addresses maintaining near constant daily release behavior by configuring the diffusion-controlled membrane to function as a diffusion-controlled, near zero-order/steady-state elution system, including fixed or constant daily release rate embodiments. Stabilization of relative movement between the implant and the drug component is discussed using haptic retention and fixation concepts, including outwardly extending haptics and attachment structures.
The document also describes implantation-adjacent placement relative to a fluid-permeable ocular membrane, notably the capsular bag, along with cartridge-style replacement of depleted drug components over time.
Claims Coverage
The independent claim provided defines an intraocular implant with two integrated elements: an implant body with outward haptics for positioning support, and a diffusion-controlled drug delivery component having a core fully encapsulated by a solid non-bioerodible membrane. Dependent claims further narrow positioning site, therapeutic agent scope, and diffusion-control parameters.
Outward haptics for position support of an intraocular implant
An implant body including a scaffold and at least one haptic extending outwardly from the scaffold, where the at least one haptic is configured to support a position of the implant body within the eye.
Drug core fully encapsulated by a solid non-bioerodible diffusion membrane
A drug delivery component configured to couple to the implant body, the drug delivery component comprising a core and a solid non-bioerodible membrane fully encapsulating the core, the core comprising at least one therapeutic agent embedded within a biocompatible, non-bioerodible polymer.
Diffusion-controlled elution through a solid non-bioerodible membrane
The solid non-bioerodible membrane is configured to permit and control a rate of elution of the at least one therapeutic agent from the core through the solid non-bioerodible membrane by diffusion.
Fixed or constant daily release rate of therapeutic agent
The intraocular implant is configured so that its drug elution occurs at a fixed or constant daily release rate.
Diffusion membrane thickness as a diffusion control parameter
A solid non-bioerodible membrane having a thickness of about 15.0 microns to about 2.0 mm.
Membrane pore size constrained relative to manufacturing pores
A solid non-bioerodible membrane with pores that are not larger than the pores existing during manufacturing of a solid sheet.
Ciliary sulcus positioning using dual haptics
An intraocular implant includes a first and a second haptic configured to retain the intraocular implant within a ciliary sulcus of the eye.
Therapeutic agent scope within the drug core
At least one therapeutic agent selected from specified therapeutic classes, including agents that lower intraocular pressure, antibiotic and anti-inflammatory agents, chemotherapeutic and nerve-regeneration agents, steroids, antioxidants, anti-proliferative/anti-mitotic agents, aptamers, complement factors, antibodies, and pharmaceutically acceptable salts or combinations thereof.
Across the provided claim set, the invention focuses on integrating an intraocular implant body with outward haptics for positioning support together with a drug delivery component where a therapeutic-agent core is fully encapsulated by a solid non-bioerodible membrane. The membrane controls diffusion-based elution, with dependent claims narrowing elution behavior to fixed or constant daily release and further constraining diffusion via membrane thickness and pore-size relationships, while expanding therapeutic-agent scope and specifying example anatomical positioning.
Stated Advantages
Near constant daily release behavior via diffusion-controlled, near zero-order/steady-state elution.
Fixed or constant daily release rate of therapeutic agent.
Documented Applications
Intraocular drug delivery adjacent to a fluid-permeable ocular membrane, including the capsular bag.
Therapeutic use for glaucoma, including bimatoprost.
Therapeutic use for inflammation, infection, and macular degeneration.
Replacement over time using cartridge-style replacement of depleted drug components.
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