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Nasolacrimal Drainage System Implants for Drug

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Nasolacrimal Drainage System Implants for Drug (19) TZZ Z_ZZ_T (11) EP 2 010 096 B1 (12) EUROPEAN PATENT SPECIFICATION (45) Date of publication and mention (51) Int Cl.: of the grant of the patent: A61F 9/00 (2006.01) A61F 9/007 (2006.01) 19.07.2017 Bulletin 2017/29 A61K 31/215 (2006.01) (21) Application number: 07759961.1 (86) International application number: PCT/US2007/065789 (22) Date of filing: 02.04.2007 (87) International publication number: WO 2007/115259 (11.10.2007 Gazette 2007/41) (54) NASOLACRIMAL DRAINAGE SYSTEM IMPLANTS FOR DRUG THERAPY IMPLANTATE MIT NASOLAKRIMALEM DRAINAGESYSTEM FÜR MEDIKAMENTÖSE THERAPIE IMPLANTS À SYSTÈME DE DRAINAGE NASOLACRYMAL POUR THÉRAPIE MÉDICAMENTEUSE (84) Designated Contracting States: • REICH, Cary AT BE BG CH CY CZ DE DK EE ES FI FR GB GR Los Gatos, California 95032 (US) HU IE IS IT LI LT LU LV MC MT NL PL PT RO SE • RAPACKI, Alan SI SK TR Redwood City, California 94025 (US) Designated Extension States: • GIFFORD, Hanson, S. AL BA HR MK RS Woodside, California 94062 (US) • DEEM, Mark (30) Priority: 31.03.2006 US 787775 P Mountain View, California 94041 (US) 26.12.2006 US 871864 P (74) Representative: HGF Limited (43) Date of publication of application: 1 City Walk 07.01.2009 Bulletin 2009/02 Leeds LS11 9DX (GB) (73) Proprietor: Mati Therapeutics Inc. (56) References cited: Austin, TX 78746 (US) EP-A1- 0 606 188 EP-A1- 2 097 044 EP-A2- 2 046 437 FR-A1- 2 747 033 (72) Inventors: FR-A1- 2 841 770 US-A- 5 283 063 • DE JUAN, JR., Eugene US-A1- 2004 092 911 US-A1- 2004 208 910 San Francisco, California 94117 (US) US-A1- 2006 020 248 US-A1- 2006 020 248 • BOYD, Stephen Murrieta, California 92562 (US) Note: Within nine months of the publication of the mention of the grant of the European patent in the European Patent Bulletin, any person may give notice to the European Patent Office of opposition to that patent, in accordance with the Implementing Regulations. Notice of opposition shall not be deemed to have been filed until the opposition fee has been paid. (Art. 99(1) European Patent Convention). EP 2 010 096 B1 Printed by Jouve, 75001 PARIS (FR) 1 EP 2 010 096 B1 2 Description provide improved drug delivery implants that overcome at least some of the above mentioned shortcomings. [0001] The present application is related to implants for use in or near the nasolacrimal drainage system, with BRIEF SUMMARY OF THE INVENTION embodiments providing canalicular implants, lacrimal 5 sac implants, punctal plugs and punctal plugs with drug [0008] The invention relates to a system as described delivery capabilities. in claim 1. Where in the following the word invention is [0002] A variety of challenges face patients and phy- used and/or features are presented as optional this sicians in the area of ocular drug delivery. In particular, should be interpreted in such way that protection is the repetitive nature of the therapies (multiple injections, 10 sought for the invention as claimed. The present inven- instilling multiple eye drop regiments per day), the asso- tion provides improved implant devices and systems for ciated costs, and the lack of patient compliance may sig- insertion into a punctum of a patient. In many embodi- nificantly impact the efficacy of the therapies available, ments, the implant device can be reliably retained in the leading to reduction in vision and many times blindness. eye such that the therapeutic agent can be delivered for [0003] Patient compliance in taking the medications, 15 an extended period of time. for example instilling the eye drops, can be erratic, and [0009] In a first aspect the invention provides a punctal in some cases, patients may not follow the directed treat- plug having a bore in which is placed a drug core insert, ment regime. Lack of compliance can include, failure to the drug core insert comprising a drug sheath comprising instill the drops, ineffective technique (instilling less than polyimide and/or another material that is substantially im- required), excessive useof the drops (leadingto systemic 20 permeable to the drug, the sheath housing a drug core side effects), and use of non-prescribed drops or failure which comprises the drug and materials to provide sus- to follow the treatment regime requiring multiple types of tained release of the therapeutic agent and an end of the drops. Many of the medications may require the patient drug core insert being exposed to contact a tear or tear to instill them up to 4 times a day. film fluid to permit diffusion of the drug into the tear of the [0004] In addition to compliance, the cost of at least 25 eye. some eye drop medications is increasing, leading some [0010] In a second aspect, there is provided a drug patients on limited incomes to be faced with the choice delivery system characterised in that it comprises a mod- of buying basic necessities or instead getting their pre- ular system that includes a drug core insert and a silicone scriptions filled. Many times insurance does not cover punctum plug that can accommodate the drug insert, the the total cost of the prescribed eye drop medication, or 30 drug insert being adapted to be placed in the bore of the in some cases eye drops containing multiple different punctum plug and being held in place via an interference medications. fit between the outer diameter of the drug insert and the [0005] Further, in many cases, topically applied med- inner diameter of the silicone plug bore, the drug core ications have a peak ocular effect within about two hours, insert comprising a drug sheath comprising polyimide after which additional applications of the medications 35 and/or another material that is substantially impermeable should be performed to maintain the therapeutic benefit. to the drug, the sheath housing a drug core which com- In addition, inconsistency in self-administered or ingest- prises the drug and materials to provide sustained re- ed medication regimes can result in a suboptimal thera- lease of the therapeutic agent and an end of the drug py. PCT Publication WO 06/014434 (Lazar) may be rel- core insert being exposed to contact a tear or tear film evant to these and/or other issues associated with eye 40 fluid to permit diffusion of the drug into the tear of the eye. drops. US 6,375,972 and US2004/208910 disclosed a [0011] A third aspect of the invention resides in an im- sustained release device for ocular delivery of drugs. The plant for insertion into a punctum of a patient, the implant device includes an inner core, a tube which encloses a comprising: portion of the core and a permeable member or plug that closes an otherwise exposed portion of the core. 45 a drug core having a distal end and a proximal end, [0006] One promising approach to ocular drug delivery the distal end of the drug core having a cross section is to place an implant that releases a drug in tissue near suitable for insertion through a punctum, the drug the eye. Although this approach can offer some improve- core comprising a therapeutic agent deliverable into ment over eye drops, some potential problems of this the eye; and approach may include implantation of the implant at the 50 a sheath disposed over a portion of the drug core, desire tissue location, retention of the implant at the de- the sheath body being made from a material that is sired tissue location, and sustaining release of the drug substantially impermeable to the therapeutic agent, at the desired therapeutic level for an extended period of time. For example in the case of glaucoma treatment, characterised in that the sheath defines at least one ex- undetected and premature loss of an implant can result 55 posed surface of the drug core, the at least one exposed in no drug being delivered, and the patient can potentially surface of the drug core located near the proximal end suffer a reduction in vision, possibly even blindness. to contact a tear or tear film fluid and release the thera- [0007] In light of the above, it would be desirable to peutic agent at therapeutic levels over a sustained period 2 3 EP 2 010 096 B1 4 when the implant is implanted for use, the rate of migra- [0016] In many embodiments, the sheath body may tion of the therapeutic agent largely being controlled by comprise a layer disposed over the drug core to inhibit the exposed surface area of the drug core that is not release of the therapeutic agent through the layer. The covered by the sheath body. drug core can release the therapeutic agent through the [0012] A fourth aspect of the invention is a drug core 5 exposed surface. The drug core may release the thera- insert for placing in a bore of a punctal plug, the drug peutic agent at therapeutic levels throughout a time pe- core insert comprising a drug sheath comprising polyim- riod of at least one week when the implant is implanted ide and/or another material that is substantially imper- with the surface exposed to the tear or tear film fluid. The meable to the drug, the sheath housing a drug core which drug core can comprise inclusions of the agent and the comprises the drug and materials to provide sustained 10 agent is soluble in the drug core to provide a substantially release of the therapeutic agent and an end of the drug uniform release rate when the drug core is implanted.
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