FIG. 10B Dition
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) ( 2 (51) International Patent Classification: SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, A61K 31/245 (2006.01) A61K 45/06 (2006.01) TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW. A61K 38/48 (2006.01) (84) Designated States (unless otherwise indicated, for every (21) International Application Number: kind of regional protection available) . ARIPO (BW, GH, PCT/US20 19/03093 1 GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, ST, SZ, TZ, UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, RU, TJ, (22) International Filing Date: TM), European (AL, AT, BE, BG, CH, CY, CZ, DE, DK, 06 May 2019 (06.05.2019) EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, LV, (25) Filing Language: English MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, SM, TR), OAPI (BF, BJ, CF, CG, Cl, CM, GA, GN, GQ, GW, (26) Publication Language: English KM, ML, MR, NE, SN, TD, TG). (30) Priority Data: 62/672,161 16 May 2018 (16.05.2018) US Published: 62/724,769 30 August 2018 (30.08.2018) US — with international search report (Art. 21(3)) 62/780,404 17 December 2018 (17. 12.2018) US 16/246,618 14 January 2019 (14.01.2019) US 62/839,738 28 April 2019 (28.04.2019) US (72) Inventor; and (71) Applicant: PEYMAN, Gholam A. [US/US]; 10850 W. Tropicana Circle, Sun City, AZ 8535 1 (US). (74) Agent: O'REILLY III, Patrick Francis; The Law Of¬ fice of Patrick F. O'Reilly III, LLC, 1509 Lafayette Drive, Columbus, OH 43220-3869 (US). (81) Designated States (unless otherwise indicated, for every kind of national protection available) : AE, AG, AL, AM, AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DJ, DK, DM, DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, HR, HU, ID, IL, IN, IR, IS, JO, JP, KE, KG, KH, KN, KP, KR, KW, KZ, LA, LC, LK, LR, LS, LU, LY, MA, MD, ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, (54) Title: METHOD OF TREATING, REDUCING, OR ALLEVIATING A MEDICAL CONDITION IN A PATIENT (57) Abstract: A method of treating, reducing, or alleviating a medical condition in a patient is disclosed herein The method includes adminis¬ ¬ n ¬ n¬ n s, n¬ s, ¬ r¬ h¬ ts s nerve regeneration, prevents scarring, and/or alleviates the medical con¬ FIG. 10B dition. TITLE OF THE INVENTION METHOD OF TREATING, REDUCING, OR ALLEVIATING A MEDICAL CONDITION IN A PATIENT CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This patent application claims priority to U.S. Provisional Patent Application No. 62/672,161, entitled “Drug Delivery Implant And A Method Using The Same”, filed on May 16, 2018; U.S. Provisional Application No. 62/724,769, entitled “Method Of Treating, Reducing, Or Alleviating A Medical Condition In A Patient”, filed on August 30, 2018; U.S. Provisional Application No. 62/780,404, entitled “Method Of Corneal And Scleral Inlay Crosslinking And Preservation”, filed on December 17, 2018; U.S. Provisional Application No. 62/839,738, entitled “Method Of Treating, Reducing, Or Alleviating A Medical Condition In A Patient”, filed on April 28, 2019; and U.S. Nonprovisional Patent Application No. 16/246,618, entitled “Methods For Treatment Of Dry Eye And Other Acute Or Chronic Inflammatory Processes”, filed on January 14, 2019; the disclosure of each of which is hereby incorporated by reference as if set forth in their entirety herein. STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT [0002] Not Applicable. NAMES OF THE PARTIES TO A JOINT RESEARCH AGREEMENT [0003] Not Applicable. INCORPORATION BY REFERENCE OF MATERIAL SUBMITTED ON A COMPACT DISK [0004] Not Applicable. BACKGROUND OF THE INVENTION 1. Field of the Invention [0005] The invention generally relates to a method for treating, reducing, or alleviating a medical condition in a patient. More particularly, the invention relates to a method for treating, reducing, or alleviating a medical condition in a patient that involves an inflammatory process, and that may be treated using a drug delivery implant. 2. Background [0006] Conventional ocular drug delivery systems include medication dissolved or suspended in a physiological solutions applied as drops to the cornea and conjunctiva bathing the superficial structure of the eye. The drops can have also particulate matter for faster tissue penetration or slow release of medication potentially lasting 1-2 days or months, etc. The medication, when applied as drops, partially penetrates the barrier of the corneal epithelium and reaches in sufficient concentration in the aqueous fluid of the anterior chamber. The aqueous is constantly produced in the eye from the ciliary body epithelium in the back or the iris in the posterior chamber and moves through the pupil in the anterior chamber, and is removed from the eye through the trabecular meshwork located in the angle of the eye between the iris and the cornea. A part of the aqueous mixes with the vitreous. In general, topically-applied medication reaches the back of the eye in lower concentrations and slower than when injected in the vitreous cavity. [0007] The injection of medication in the eye cavity, in the form of solution or micro particulates, can bypass the ocular barrier and effectively treat the retinal and choroidal diseases, for months. Therefore, they have to be reinjected frequently in chronic disease of the eye. [0008] The polymeric slow release systems release the medication inside the eye and have been implanted in the vitreous cavity, over or under the retina, providing medication only to the back of the eye for a period of 3 months to a year. [0009] In general, a drug delivery device has been implanted in most places of the eye, except in the cornea. A non-biodegradable device can be injected in the vitreous cavity if they are very small otherwise, they can move around scratching the retina or move to the anterior chamber damaging the comeal endothelial cells. However, they can be sutured in the sclera with their anchoring section, while the drug delivery section is located inside the eye, i.e., in the vitreous cavity to release the medication. [0010] These devices, in general, initiate a foreign body response associated with fibroblast cell migration around the device, and the device becomes encapsulated, making the amount of drug release unpredictable through the thick fibrotic scar tissue. [0011] Similarly, stem cellular drug delivery devices, such as ciliary body neurotrophic factors that produce needed factors for the retinal survival in certain degenerative diseases can be only be implanted inside the vitreous cavity where it is considered an immune- privileged space. Otherwise, it becomes encapsulated by the scar tissue and become less effective. The vitreous cavity is considered an immune privileged space meaning that blood vessels have no access to it to produce a cellular immune response that would attack and destroy the stem cells or surround a device with a fibrous membrane which would make the system useless. [0012] To date, in general, the cornea has not been considered a suitable location to implant a slow release drug delivery device because of concern that it becomes vascularized affecting the transparency of cornea, which is vital for passing the light through it to reach the photoreceptors of the retina creating sensation of vision. [0013] Therefore, it is apparent that a need exists for a drug delivery implant and a method using the same that is capable of effectively delivering medications to the cornea of the eye and to parts of the body other than the cornea of the eye. [0014] Further, it is known that on the cell surface membrane, Wnt proteins bind to receptors of the Frizzled and LRP protein families causing accumulation of beta-catenin in the cytoplasm and its translocation in the nucleus that forms a complex with transcriptional cofactor (TCF) to activate the transcription of Wnt targeted genes. [0015] The Wnt pathway is considered canonical when it is dependent on beta-catenin, or non-canonical when it is independent. The canonical Wnt/p-catenin plays an important role in the expression of several inflammatory molecules during acute or chronic inflammatory diseases affecting mucosal surfaces of the body. [0016] It is known that innate immunity protects the host cells from invasion and infection and development of an adaptive immune response. However, uncontrolled inflammation causes damage to the tissue. [0017] Conventional oral medication or topical medications used for the mucosa have contained steroids, systemic medication, such as hormonal therapy and or omega-3 oil along with systemic medications, have unwanted side effects and are not tolerated by many patients. [0018] As such, an improved treatment method is needed for an inflammatory process that involves the conjunctiva, sclera, optic nerve, nasal, oral and throat including dry eye syndrome, mucosal form of lichen planus, psoriasis, and inflammatory bowel diseases, plantar fasciitis, skin form of lichen planus or chronic pain caused by inflammatory disease affecting the nerves such as in diabetes or after surgery or trauma, etc. BRIEF SUMMARY OF EMBODIMENTS OF THE INVENTION [0019] Accordingly, the present invention is directed to a drug delivery implant and a method using the same that substantially obviates one or more problems resulting from the limitations and deficiencies of the related art. [0020] In accordance with one or more embodiments of the present invention, there is provided a method of treating, reducing, or alleviating a medical condition in a patient.