Ocular implant containing a tyrosine kinase inhibitor
AssigneeOcular Therapeutix, Inc.
InventorsCharles D. BLIZZARD, Erica KAHN, Peter JARRETT, Rabia GURSES-OZDEN, Rami EL-HAYEK, Elizabeth BRAUN, Joseph IACONA, Chintan PATEL, Mark RANSBOTTOM, Olivia SHERMAN, William ISOM
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Abstract
The invention relates to a sustained release biodegradable ocular implant containing axitinib dispersed in a hydrogel for the treatment of a retinal disease for an extended period of time.
Claims22
1-110. (canceled)
A sustained release biodegradable ocular implant comprising a hydrogel and axitinib, wherein axitinib particles are dispersed within the hydrogel, wherein the percentage of axitinib released from the implant in an in vitro test performed at 35° C.±0.5° C. in 0.01N HCl with 0.25% cetyl trimethyl ammonium bromide (CTAB) in a USP apparatus 4 is:
- from about 10 to about 25% after 0.5 hours,
- from about 30 to about 50% after 2 hours,
- from about 60 to about 90% after 6 hours,
- from about 79 to about 100% after 10 hours,
- at least about 90% after 12 hours,
- or at least about 92% after 16 hours.
A sustained release biodegradable ocular implant comprising a hydrogel and axitinib, wherein axitinib particles are dispersed within the hydrogel, wherein the percentage of axitinib released from the implant in an in vitro test performed at 35° C.±0.5° C. in 0.01N HCl with 0.25% cetyl trimethyl ammonium bromide (CTAB) in a USP apparatus 4 is:
- from about 10 to about 25% after 0.5 hours,
- from about 30 to about 50% after 2 hours,
- from about 60 to about 90% after 6 hours,
- from about 79 to about 100% after 10 hours,
- at least about 90% after 12 hours,
- and at least about 92% after 16 hours.
A sustained release biodegradable ocular implant comprising a hydrogel and axitinib, wherein axitinib particles are dispersed within the hydrogel, wherein the percentage of axitinib released from the implant in an in vitro test performed at 35° C.±0.5° C. in 0.01N HCl with 0.25% cetyl trimethyl ammonium bromide (CTAB) in a USP apparatus 4 is:
- from about 12 to about 17% after 0.5 hours,
- from about 32 to about 42% after 2 hours,
- from about 62 to about 78% after 6 hours,
- from about 83 to about 97% after 10 hours,
- or at least about 94% after 16 hours.
A sustained release biodegradable ocular implant comprising a hydrogel and axitinib, wherein axitinib particles are dispersed within the hydrogel, wherein the percentage of axitinib released from the implant in an in vitro test performed at 35° C.±0.5° C. in 0.01N HCl with 0.25% cetyl trimethyl ammonium bromide (CTAB) in a USP apparatus 4 is:
- from about 12 to about 17% after 0.5 hours,
- from about 32 to about 42% after 2 hours,
- from about 62 to about 78% after 6 hours,
- from about 83 to about 97% after 10 hours,
- and at least about 94% after 16 hours.
A sustained release biodegradable ocular implant comprising a hydrogel and axitinib, wherein axitinib particles are dispersed within the hydrogel, wherein the percentage of axitinib released from the implant in an in vitro test performed at 35° C.±0.5° C. in 0.01N HCl with 0.25% cetyl trimethyl ammonium bromide (CTAB) in a USP apparatus 4 is:
- at least about 10% after 0.5 hours,
- at least about 30% after 2 hours,
- at least about 58% after 6 hours,
- at least about 75% after 10 hours,
- at least about 80% after 12 hours,
- or at least about 90% after 16 hours.
A sustained release biodegradable ocular implant comprising a hydrogel and axitinib, wherein axitinib particles are dispersed within the hydrogel, wherein the percentage of axitinib released from the implant in an in vitro test performed at 35° C.±0.5° C. in 0.01N HCl with 0.25% cetyl trimethyl ammonium bromide (CTAB) in a USP apparatus 4 is:
- at least about 10% after 0.5 hours,
- at least about 30% after 2 hours,
- at least about 58% after 6 hours,
- at least about 75% after 10 hours,
- at least about 80% after 12 hours,
- and at least about 90% after 16 hours.
A sustained release biodegradable ocular implant comprising a hydrogel and axitinib, wherein axitinib particles are dispersed within the hydrogel, wherein the percentage of axitinib released from the implant in an in vitro test performed at 35° C.±0.5° C. in 0.01N HCl with 0.25% cetyl trimethyl ammonium bromide (CTAB) in a USP apparatus 4 is:
- from about 50 to about 80 μg after 0.5 hours,
- from about 140 to about 200 μg after 2 hours,
- from about 270 to about 360 μg after 6 hours,
- from about 350 to about 450 μg after 10 hours,
- and at least about 410 μg after 16 hours.
Dependencies are inferred from the claim text.