Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Implant or insert
Patent
1994-11-02
1995-10-31
Page, Thurman K.
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Implant or insert
424 9467, 514912, 514913, 514915, 606 6, 606 4, 604 8, 604 9, 604 10, 604294, 351245, 351246, 356125, 356127, A61F 200
Patent
active
054627397
DESCRIPTION:
BRIEF SUMMARY
The present invention concerns a device and method of application for pinpoint delivery of micro-quantities of pharmaceutical compositions such as collagenase to a predetermined location on the outer hard coat of the eye, resulting in increased permeability at that location. The method is useful in the treatment of glaucoma when applied to the limbus, by increasing outflow facility. When treating other ocular disorders, the method may be applied at other locations of the sclera to enhance penetration into the eye of periocularly administered drugs.
BACKGROUND OF THE INVENTION
Collagen is the major constituent of the tissues forming the eye coat (Collagenase, Mandel, I. "Collagenase comes of age", p.1, Gordon and Breech, Science Publishers, Inc. 1972). Enzymes such as collagenase, which degrade collagen, are of importance in controlling conditions involving the collagen-rich tissue.
The use of enzymes in the medical field is well known. For example, alpha-chymotrypsin was used to lyse zonules in cataract surgery (I.C.C.E), hyaluronidase is used extraocularly as a means for spreading local anesthesia more effectively through tissue, and Tissue Plasminogen Activator has been proposed for clot-removal and filtering bleb reformation. The use of proteolytic enzymes as biopolymeric dry composition for treatment of wounds has been reported in U.S. Pat. No. 4,613,502. Detoxified agents such as enzymes obtained from snake venom have been used in the treatment of ocular disorders as disclosed in U.S. Pat. No. 3,869,548. Another bacterial extract, the toxin from Clostridium botulinus was proposed by Scott (J. Ped. Opthal. 17;21) in 1980 for use in ophthamology replacing strabismus surgery.
The use of collagenase has been disclosed in the art. Processes for production of collagenase from the bacterium Clostridium histolyticum have been disclosed in U.S. Pat. Nos. 3,705,083 and 3,821,364. Processes for preparing other collagenase preparations have been disclosed in U.S. Pat. Nos. 3,267,006 and 3,677,900. Collagenase has been used in the treatment of herniated intervertebral disc and such treatment is disclosed in U.S. Pat. No. 3,678,158. Use of collagenase as an adjunct to vitrectomy with membranectomy was proposed in U.S. Pat. No. 3,678,158. Use of collagenase has been described as an inhibitor of collagen-induced platelet aggregation and to be useful in selective degradation of collagen in the eye to remove scar tissue (European Patent Application No. 233,908). Collagenase obtained from Vibrio alginolyticus is said to be useful to prevent formation of deep scars during healing of burns and other lesions and has been proposed to treat dental caries, dental pulp and skin burns (U.S. Pat. No. 4,732,758). Soviet Union Patent No. 1,286,195 describes a method of treatment of glaucoma involving the formation of paths of outflow of intraocular fluid by direct injection of a proteolytic enzyme, leucozyme, into the sclera 3 mm posteriorly to the limbus.
The following brief discussion concerning basic ocular histology, anatomy and ophthalmic surgery serves to describe the collagen rich composition of the sclera and limbus, their involvement in ocular diseases such as glaucoma and the problems facing ophthalmic surgeons who are concerned with the treatment of it. Basically the hard outer layer of the mammal/an eyeball is formed by the opaque white sclera (83%) continued anteriorly by the cornea (16%) and posteriorly by the optic nerve sheath (<1%). These are densely collagenous hypocellular structures composed of (75%) of hydroxyproline-rich collagen, elastic tissue and mucopolysaccharides. The collagen fiber diameter varies between 28-300 nm with a periodicity of 64 nm. Embedded in mucopolysaccharide rich substance, the bundles are approximately parallel to the surface which in the cornea have a strict layering, responsible for its vital transparency. In the sclera and sclerocorneal junction the inner collagen bundles near, the Schlem canal are relatively inactive metabolically, having no intrinsic capillary bed and only a
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Dan Jacov
Yaron Arieh
Page Thurman K.
Webber Pamela S.
Yeda Research and Development Co. Ltd.
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