Ocular insert with anchoring protrusions
First Claim
1. A flexible ocular insert device adapted for the controlled sustained release of an ophthalmic drug upon insertion into the upper or lower fornix of the eye, said device comprising an elongated body of a polymeric material in the form of a rod or tube containing a pharmaceutically active ingredient and with at least two anchoring protrusions extending radially outwardly from said body, said device having a length of at least 8 mm and a diameter including protrusions not exceeding 1.9 mm, wherein said device is sufficiently flexible to allow it to bend along the curvature of the eye within the upper or lower fornix upon being positioned so that the longitudinal axis of said device is generally parallel to the transverse diameter of the eyeball, said device being of a size and configuration such that, upon insertion into the upper or lower fornix, the device does not extend onto any visible portion of the eyeball, said device being independent of movement of the eye and remaining out of the field of vision so as to be well retained in place and imperceptible by a patient over a prolonged period of use, said protrusions acting to minimize lateral movement of the device within the fornix, whereby the device when inserted into the upper or lower fornix can be retained therein for more than seven days.
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Accused Products
Abstract
A flexible ocular insert device adapted for the controlled sustained release of an ophthalmic drug into the eye. In one embodiment, the device includes an elongated body of a polymeric material in the form of a rod or tube containing a pharmaceutically active ingredient and with at least two anchoring protrusions extending radially outwardly from the body. The device has a length of at least 8 mm and the diameter of its body portion including the protrusions does not exceed 1.9 mm. The sustained release mechanism may, for example, be by diffusion or by osmosis or bioerosion. The insert device is advantageously inserted into the upper or lower fornix of the eye so as to be independent of movement of the eye by virtue of the fornix anatomy. The protrusions may be of various shapes such as, for example, ribs, screw threads, dimples or bumps, truncated cone-shaped segments or winding braid segments. In a further embodiment, the polymeric material for the body is selected as one which swells in a liquid environment. Thus a device of smaller initial size may be employed. The present insert device is of a size and configuration such that, upon insertion into the upper or lower fornix, the device remains out of the field of vision so as to be well retained in place and imperceptible by a patient over a prolonged period of use. The device can be retained in the upper or lower fornix for 7 to 14 days or longer.
131 Citations
22 Claims
- 1. A flexible ocular insert device adapted for the controlled sustained release of an ophthalmic drug upon insertion into the upper or lower fornix of the eye, said device comprising an elongated body of a polymeric material in the form of a rod or tube containing a pharmaceutically active ingredient and with at least two anchoring protrusions extending radially outwardly from said body, said device having a length of at least 8 mm and a diameter including protrusions not exceeding 1.9 mm, wherein said device is sufficiently flexible to allow it to bend along the curvature of the eye within the upper or lower fornix upon being positioned so that the longitudinal axis of said device is generally parallel to the transverse diameter of the eyeball, said device being of a size and configuration such that, upon insertion into the upper or lower fornix, the device does not extend onto any visible portion of the eyeball, said device being independent of movement of the eye and remaining out of the field of vision so as to be well retained in place and imperceptible by a patient over a prolonged period of use, said protrusions acting to minimize lateral movement of the device within the fornix, whereby the device when inserted into the upper or lower fornix can be retained therein for more than seven days.
Specification
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- Resources
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Current AssigneeEscalon Ophthalmics Incorporated
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Original AssigneeEscalon Ophthalmics Incorporated
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InventorsWeiner, Alan L., Darougar, Sohrab
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Primary Examiner(s)Page, Thurman K.
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Assistant Examiner(s)Hulina, Amy
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Application NumberUS08/243,915Time in Patent Office294 DaysField of Search424/427, 424/428, 424/422, 424/429, 604/890.1US Class Current424/427CPC Class CodesA61F 9/0017 implantable in, or in conta...A61K 9/0051 Ocular inserts, ocular impl...
