Patent SG-11201906729R-A (SG)
Title: Topical cyclosporine-containing formulations and uses thereof
Inventor: WEISS SIDNEY L
IPC: A61P27/02
Filed: 2017-02-28
Abstract: WO 17 / 15 1657 Al (12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (43) International Publication Date 8 September 2017 (08.09.2017) WIPO I PCT (10) International Publication Number WO 2017/151657 Al 111111111111110111011111111111010111110111011111111011111111111111111111111111110111111 Clin ica lly Sign ifican t Chang e from Base line ( >_ 1Omm) 15% p=0.128 (51) International Patent Classification: A61K 38/13 (2006.01) A61P 27/02 (2006.01) (21) International Application Number: PCT/US2017/020008 (22) International Filing Date: 28 February 2017 (28.02.2017) (25) Filing Language: English (26) Publication Language: English (30) Priority Data: 62/301,576 29 February 2016 (29.02.2016) US 62/302,058 1 March 2016 (01.03.2016) US 62/302,730 2 March 2016 (02.03.2016) US 62/311,177 21 March 2016 (21.03.2016) US (71) Applicant: OCULAR TECHNOLOGIES SARL [CH/CH]; Route de la Corniche 3B, 1066 Epalinges (CH). (72) Inventors; and (71) Applicants : WEISS, Sidney L. [US/US]; 6 Dawn Lane, Randolph, New Jersey 07869 (US). MITRA, Ashim K. [US/US]; 15065 Stearns Street, Overland Park, Kansas 66221 (US). MCNALLY, Eugene J. [US/US]; 3037 Bosshard Drive, Fitchburg, Wisconsin 53711 (US). (74) Agent: WOODHOUSE, Scott, M.; Medler Ferro Wood- house & Mills PLLC, 8201 Greensboro Drive, Suite 1060, McLean, VA 22102 (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, 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, SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW. (84) Designated States (unless otherwise indicated, for every kind of regional protection available): ARIPO (BW, GH, GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, ST, SZ, TZ, UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, RU, TJ, TM), European (AL, AT, BE, BG, CH, CY, CZ, DE, [Continued on next page] (54) Title: TOPICAL CYCLOSPORINE-CONTAINING FORMULATIONS AND USES THEREOF (57) : Provided herein are formulations for topical 20% ophthalmic formulations containing 0.087-0.093 wt% of cyclosporine, and methods of making and using such formu- lations. In some aspects and embodiments the formulations 1 7 9 may include a polyoxyl lipid or fatty acid, and/or a polyalkoxylated alcohol and may include nanomicelles. Also included herein are methods of treating or preventing dis- eases or conditions, such as ocular diseases or conditions. 10% - 5% - 0% OTX-101 0.09% ;.:,° OTX101 0.05% /ehicle Figure I WO 2017/151657 Al MIDEDIMOMOIDEIR010131EMOHIMMERVOIMIE DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, SM, TR), OAPI (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, GW, KM, ML, MR, NE, SN, TD, TG). Declarations under Rule 4.17: as to applicant's entitlement to apply for and be granted a patent (Rule 4.17(ii)) as to the applicant's entitlement to claim the priority of the earlier application (Rule 4.17(iii)) Published: with international search report (Art. 21(3))