US20150258120A1 - Methods and devices for the treatment of ocular diseases in human subjects - Google Patents

Methods and devices for the treatment of ocular diseases in human subjects Download PDF

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US20150258120A1
US20150258120A1 US14/441,151 US201314441151A US2015258120A1 US 20150258120 A1 US20150258120 A1 US 20150258120A1 US 201314441151 A US201314441151 A US 201314441151A US 2015258120 A1 US2015258120 A1 US 2015258120A1
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drug
microneedle
eye
scs
antibody
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Vladimir ZARNITSYN
Samirkumar Patel
Daniel White
Glenn Noronha
Brian Burke
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Clearside Biomedical Inc
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Clearside Biomedical Inc
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Assigned to CLEARSIDE BIOMEDICAL, INC. reassignment CLEARSIDE BIOMEDICAL, INC. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: BURKE, BRIAN, NORONHA, GLENN, PATEL, Samirkumar, WHITE, DANIEL, ZARNITSYN, Vladimir
Publication of US20150258120A1 publication Critical patent/US20150258120A1/en
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Assigned to CLEARSIDE BIOMEDICAL, INC. reassignment CLEARSIDE BIOMEDICAL, INC. RELEASE BY SECURED PARTY (SEE DOCUMENT FOR DETAILS). Assignors: SILICON VALLEY BANK
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    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/4427—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems
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    • A61K31/573—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
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    • C—CHEMISTRY; METALLURGY
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    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/22—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against growth factors ; against growth regulators
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    • A61M2037/0061—Methods for using microneedles

Definitions

  • FIG. 20B is a cross sectional image of a rabbit eye following suprachoroidal injection of 3.2 mg triamcinolone (left) or vehicle (right).
  • Posterior segment of eyes injected with LPS IVT and low dose TA in SCS (Group 3). Scale bar: 200 ⁇ m.
  • G Anterior segment of eyes injected with LPS IVT and high dose TA in SCS (Group 4). Scale bar: 1 mm.
  • H Posterior segment of eyes injected with LPS IVT and high dose TA in SCS (Group 4). Arrows indicate presence of TA in SCS. Scale bar: 200 ⁇ m.
  • I. Anterior segment of eyes injected with LPS IVT and low dose TA IVT (Group 5). Scale bar: 1 mm.
  • J Posterior segment of eyes injected with LPS IVT and low dose TA IVT (Group 5). Scale bar: 200 ⁇ m.
  • the microneedle device for non-surgically delivering drug to the suprachoroidal space of the eye of a human subject comprises a hollow microneedle.
  • the device may include an elongated housing for holding the proximal end of the microneedle.
  • the device may further include a means for conducting a drug formulation through the microneedle.
  • the means may be a flexible or rigid conduit in fluid connection with the base or proximal end of the microneedle.
  • the means may also include a pump or other devices for creating a pressure gradient for inducing fluid flow through the device.
  • the conduit may in operable connection with a source of the drug formulation.
  • the source may be any suitable container. In one embodiment, the source may be in the form of a conventional syringe.
  • the source may be a disposable unit dose container.
  • the posterior ocular disorders amenable for treatment by the methods, devices, and drug formulations described herein may be acute or chronic.
  • the ocular disease may be acute or chronic uveitis.
  • Uveitis can be caused by infection with viruses, fungi, or parasites; the presence of noninfectious foreign substances in the eye; autoimmune diseases; or surgical or traumatic injury.
  • the suprachoroidal drug dose sufficient to achieve a therapeutic response in a human subject treated with the non-surgical SCS drug delivery method is less than the intravitreal, parenteral, intracameral, topical, or oral drug dose sufficient to elicit the identical or substantially identical therapeutic response.
  • the suprachoroidal drug dose is at least 10 percent less than the oral, parenteral or intravitreal dose sufficient to achieve the identical or substantially identical therapeutic response.
  • the suprachoroidal dose is about 10 percent to about 25 percent less, or about 10 percent to about 50 percent less than the oral, parenteral, intracameral, topical, or intravitreal dose sufficient to achieve the identical or substantially identical therapeutic response.
  • This delivery method can be particularly advantageous with ocular tissues, where it is desirable for the insertion and withdrawal process to occur over as short a period as possible to minimize patient discomfort—in contrast to transdermal microneedle patch applications, where patches may more likely be worn (with microneedles inserted) over an extended period without patient discomfort.
  • the efficacy of the drug for example infliximab (Remicade®)
  • infliximab can be measured, for example, by observing changes in retinal thickness, inflammation, visual acuity, photophobia, typical time between flares, corneal ulceration, and/or edema.
  • the efficacy of the drug for example nepafenac
  • OCT optical coherence tomography
  • a method for treating a patient for multi-focal choroiditis comprises non-surgically administering a drug formulation comprising an effective amount of a MFC treating drug to the SCS of one or both eyes of the patient in need of MFC treatment.
  • the drug formulation is administered, in one embodiment, with one of the microneedles described herein.
  • the intraocular elimination half life (tin) of the angiogenesis inhibitor administered to the SCS is greater than the intraocular t 1/2 of the angiogenesis inhibitor, when the identical dosage of the angiogenesis inhibitor is administered intravitreally, intracamerally, topically, parenterally or orally.
  • the mean intraocular maximum concentration (C max ) of the angiogenesis inhibitor when the identical dosage of the angiogenesis inhibitor is administered to the SCS via the methods described herein, is greater than the intraocular C max of the angiogenesis inhibitor, when the identical dosage is administered intravitreally, intracamerally, topically, parenterally or orally.
  • the mean intraocular area under the curve (AUC 0-t ) of the PDGF antagonist when administered to the SCS via the methods described herein, is greater than the intraocular AUC 0-t of the PDGF antagonist, when the identical dosage of the PDGF antagonist is administered intravitreally, intracamerally, topically, parenterally or orally.
  • the drug is a steroid or a non-steroid anti-inflammatory drug (NSAID).
  • the anti-inflammatory drug is an antibody or fragment thereof, an anti-inflammatory peptide(s) or an anti-inflammatory aptamer(s).
  • the delivery of the anti-inflammatory drug to the suprachoroidal space results in benefits over administration of the same drug delivered via oral, intravitreal, intracameral, topical and/or a parenteral route of administration.
  • the therapeutic effect of the drug delivered to the suprachoroidal space is greater than the therapeutic effect of the same drug, delivered at the same dosage, when the drug is delivered via oral, intravitreal, topical or parenteral route.
  • Scanco ⁇ CT40 desktop conebeam system Scanco Medical AG, Brüttisellen, Switzerland
  • TA triamcinolone acetonide
  • FIG. 33 shows the mean TA concentration in plasma, ⁇ SD, as measured in 8 rabbits. Systemic exposure to TA following suprachoroidal administration was minimal with a mean C max of 12 ng/mL on Day 1.

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US14/441,151 2012-11-08 2013-11-08 Methods and devices for the treatment of ocular diseases in human subjects Abandoned US20150258120A1 (en)

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US201261724144P 2012-11-08 2012-11-08
US201261734872P 2012-12-07 2012-12-07
US201261745237P 2012-12-21 2012-12-21
US201361773124P 2013-03-05 2013-03-05
US201361785229P 2013-03-14 2013-03-14
US201361819388P 2013-05-03 2013-05-03
US201361873660P 2013-09-04 2013-09-04
US201361898926P 2013-11-01 2013-11-01
US14/441,151 US20150258120A1 (en) 2012-11-08 2013-11-08 Methods and devices for the treatment of ocular diseases in human subjects
PCT/US2013/069156 WO2014074823A1 (en) 2012-11-08 2013-11-08 Methods and devices for the treatment of ocular diseases in human subjects

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US15/001,610 Continuation US9636332B2 (en) 2012-11-08 2016-01-20 Methods and devices for the treatment of ocular diseases in human subjects
US15/454,636 Continuation US20180028516A1 (en) 2012-11-08 2017-03-09 Methods and devices for the treatment of ocular diseases in human subjects

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US14/441,151 Abandoned US20150258120A1 (en) 2012-11-08 2013-11-08 Methods and devices for the treatment of ocular diseases in human subjects
US15/001,610 Active US9636332B2 (en) 2012-11-08 2016-01-20 Methods and devices for the treatment of ocular diseases in human subjects
US15/086,485 Active US9572800B2 (en) 2012-11-08 2016-03-31 Methods and devices for the treatment of ocular diseases in human subjects
US15/454,636 Abandoned US20180028516A1 (en) 2012-11-08 2017-03-09 Methods and devices for the treatment of ocular diseases in human subjects
US15/673,073 Active US9931330B2 (en) 2012-11-08 2017-08-09 Methods and devices for the treatment of ocular diseases in human subjects
US15/830,727 Abandoned US20180092897A1 (en) 2012-11-08 2017-12-04 Methods and devices for the treatment of ocular diseases in human subjects
US16/041,067 Abandoned US20180325884A1 (en) 2012-11-08 2018-07-20 Methods and devices for the treatment of ocular diseases in human subjects
US16/124,407 Abandoned US20190240208A1 (en) 2012-11-08 2018-09-07 Methods and devices for the treatment of ocular diseases in human subjects
US16/737,010 Abandoned US20200383965A1 (en) 2012-11-08 2020-01-08 Methods and devices for the treatment of ocular diseases in human subjects
US17/314,272 Pending US20210260047A1 (en) 2012-11-08 2021-05-07 Methods and devices for the treatment of ocular diseases in human subjects

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US15/001,610 Active US9636332B2 (en) 2012-11-08 2016-01-20 Methods and devices for the treatment of ocular diseases in human subjects
US15/086,485 Active US9572800B2 (en) 2012-11-08 2016-03-31 Methods and devices for the treatment of ocular diseases in human subjects
US15/454,636 Abandoned US20180028516A1 (en) 2012-11-08 2017-03-09 Methods and devices for the treatment of ocular diseases in human subjects
US15/673,073 Active US9931330B2 (en) 2012-11-08 2017-08-09 Methods and devices for the treatment of ocular diseases in human subjects
US15/830,727 Abandoned US20180092897A1 (en) 2012-11-08 2017-12-04 Methods and devices for the treatment of ocular diseases in human subjects
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