Guðrún Marta Ásgrímdóttir lyfjafræðingur
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1 Guðrún Marta Ásgrímdóttir lyfjafræðingur Nanóagnir Nýjar lyfjaferjur
2 Oculis ehf. Markmið Þróa og markaðssetja lyfjaferjur fyrir augnlyf til að bæta meðferð við augnsjúkdómum 2
3 Oculis ehf. Ávinningur af lyfjaferjum Augndropar í staðinn fyrir lyf gefið með sprautunál á skurðstofu Lyf gefið EINU SINNI á dag í stað 2-3svar á dag 3
4 Oculis stofnað 2003 Próf. Þorsteinn Loftsson og próf. Einar Stefánsson Eigendur eru stofnendur ásamt LSH og HÍ Tvö einkaleyfi í USA og umsókn í Evrópu Rekið á styrkjum Oculis ehf. Rannís, Landsbankinn, Átak til atvinnusköpunar 4
5 Oculis ehf. Þróun lyfjaforms og stöðugleikarannsóknir: Thorsteinn Loftsson PhD co-founder Maria Dolores Moya Ortega PhD Sunna Johannsdottir MSc Chutimon Muankaew MSc Phatsawee Jansook PhD Sergey Kurkov PhD Klínískar rannsóknir: Einar Stefánsson MD, PhD, co-founder Guðrún Ásgrímsdottir MSc, CEO Gauti Jóhannesson MD, PhD Birna Guðmundsdóttir MD María Soffía Gottfreðsdóttir MD Viðskiptaþróun: Pétur Stefánsson, MBA, CFO International collaborators in Japan, Germany, Sweden, USA, Netherlands, Denmark, Finland, Israel 5
6 Lyfjagjöf í augu Hefðbundnir augndropar minna en 5% fer inní augað Ekki hægt að nota fyrir bakhluta augans Oculis augndropar með nanóögnum Um 50% fer inní augað Lyf kemst að sjónhimnu 6
7 Klínískar rannsóknir DexNP - Dexamethasone augndropar notaðir í 2 sjúkdómum Sjónhimnubjúg í sykursýki (DME) Augnbólgu DorzNP - Dorzolamide augndropar notaðir við gláku 7
8 Styrkur dexamethasone í táravökva Kanínu rannsókn Klínísk rannsókn Maxidex Dex NP Aqueous dexamethasone/γcd microparticle eye drop suspension AUC x100
9 19 augu með langvinna DME (sjónhimnubjúg í sykursýki) DexNP augndropar við DME (sjónhimnubjúg í sykursýki)* Vika 1-4: DexNP 3 eða 6 sinnum á dag Vika 5-8: Fylgst með sjúklingum Mæld sjónskerpa, augnþrýstingur og þykkt sjónhimnu við 0, 4 og 8 vikur *Tanito et al, IOVS
10 Central macular thickness (µm) DexNP augndropar bæta sjón draga úr þykkt sjónhimnu í DME ETDRS stafir: 74 --> > Aukning 7.5 stafir 10
11 Bætt sjón í sjónhimnubjúg í sykursýki (ETDRS letters) Dex. augndropar nanóagnir 7.5 Ozurdex 6 Trimacinolone intravitreal 4-6 ILUVIEN implant Lucentis 6-9 VEGF-trap Laser
12 DexNP og augnbólga Rannsókn í gangi í Tel Aviv Rannsókn áætluð í Stokkhólmi 12
13 Glákulyf DorzNP einu sinni vs. Trusopt þrisvar IOP (mmhg) Dorzolamide-cyclodextrin Trusopt Time (hours) Dorz-NP einu sinni vs. Trusopt á 8 klst. fresti Dorz-NP = cyclodextrin nanóagnir dorzolamide augndropar Trusopt= dorzolamide augndropar *Gudmundsdottir et al ARVO 2012, JOPT online publication
14 Yfirlit yfir rannsóknir á DexNP augndropum DME DexNP vs. Placebo Japan - completed DexNP vs. TA. Japan - recruiting DexNP vs. TA. Mannheim - in wait Uveitis DexNP observational Israel - recruiting DexNP observational Stockholm - prepared Pharmacokinetics Tear film: DexNP, DorzNP. Reykjavik, - completed Vitreous DexNP, Rotterdam - prepared Post-op cataract, DexNP vs. Maxidex Uppsala - prepared Glaucoma surgery, DexNP vs. Mitamicin C. Reykjavik - recruiting Cornea neovasc., DexNP, Dusseldorf - in wait 14
15 Markaður Sjónhimnubjúgur í sykursýki og augnbólga Sjónhimnubjúgur í sykursýki er algengur sjúkdómur og tíðnin eykst hratt Árið 2013 voru 380 milljónir sykursjúkir milljónir hafa sjónhimnubjúg Uveitis er alvarlegur sjúkdómur ný tilfelli í USA á ári 15
16 Markaður - sjónhimnubjúgur í sykursýki - 7 stærstu svæðin (7MM) Prevalence of DME by country (2010, thousands) DME prevalence (treated patients) JAPAN; 507 3,600 SPAIN; 155 3,500 3,532 ITALY; 290 GERMANY; 281 USA; # patients (000) 3,400 3,300 3,200 3,100 3,182 3,385 FRANCE; 168 UK; 198 3,
17 Plan Novel non-invasive treatment for major eye disease Ljúka fasa 2 rannsóknum í DME og uveitis Undirbúa fasa 3 rannsóknir og skráningu Ljúka við þróun á umbúðum og stöðugleikarannsóknum Halda áfram með rannsóknir á nýjum lyfjaflokkum Ljúka fasa 3 rannsóknum í DME og uveitis Ljúka skráningu hjá EMA (hybrid) og FDA (505(b)(2)) Nýir lyfjaflokkar 17
18 Summary Lyfjaferjur fyrir fjölbreytta lyfjaflokka Lofandi niðurstöður úr fasa II Aukaverkanir lyfjanna vel þekktar minni áhætta Hjálparefni vel þekkt minni áhætta Einkaleyfi Góðir markaðsmöguleikar og hátt verð 18
19 Would you like an eye-drop or shall I stick a needle in your eye? 19
20 Back up 20
21 Intellectual property Thorsteinn Loftsson and Einar Stefánsson Cyclodextrin nanotechnology for ophthalmic drug delivery, US patent 7,892,040 B2, Feb 22, Oculis ehf. Thorsteinn Loftsson and Einar Stefánsson Cyclodextrin nanotechnology for ophthalmic drug delivery, US continuation/divisional application (Filed: 27 January 2011). Oculis ehf. Thorsteinn Loftsson and Einar Stefánsson, Cyclodextrin nanotechnology for ophthalmic drug delivery, Int. Appl. No. PCT/IB2006/ (Filed: 21 July 2006). Oculis ehf. Further patent applications are in preparation All patents owned by Oculis ehf. 21
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