(12) United States Patent (10) Patent No.: US 9,572,800 B2 Zarnitsyn Et Al
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USOO9572800B2 (12) United States Patent (10) Patent No.: US 9,572,800 B2 Zarnitsyn et al. (45) Date of Patent: Feb. 21, 2017 (54) METHODS AND DEVICES FOR THE A61K 31/573; A61K 2300/00; A61 K TREATMENT OF OCULAR DISEASES IN 2039/505; A61K 2039/54: A61K 45/06; HUMAN SUBJECTS A61K 47/12: A61K 47/26: A61K 47/38: A61 K9/0019; A61 K9/10; A61M (71) Applicant: Clearside Biomedical, Inc., Alpharetta, 2037/0023; A61M 37/0015; C07K 16/22 GA (US) See application file for complete search history. (72) Inventors: Vladimir Zarnitsyn, Atlanta, GA (US); (56) References Cited Samirkumar Patel, Atlanta, GA (US); Daniel White, Suwanee, GA (US); U.S. PATENT DOCUMENTS Glenn Noronha, Atlanta, GA (US); 2,187,259 A 1/1940 Barnhart Brian Burke, Cary, NC (US); Jennifer 3,477,432 A 11, 1969 Shaw Kissner, Alpharetta, GA (US) (Continued) (73) Assignee: CLEARSIDE BIOMEDICAL, INC., Alpharetta, GA (US) FOREIGN PATENT DOCUMENTS CN 1706365 12/2005 (*) Notice: Subject to any disclaimer, the term of this CN 1736474 2, 2006 patent is extended or adjusted under 35 (Continued) U.S.C. 154(b) by 0 days. OTHER PUBLICATIONS (21) Appl. No.: 15/086,485 Office Action for U.S. Appl. No. 1 1/743,535, mailed Aug. 19, 2010, (22) Filed: Mar. 31, 2016 7 pages. (65) Prior Publication Data (Continued) US 201670213662 A1 Jul. 28, 2016 Primary Examiner — Aradhana Sasan (74) Attorney, Agent, or Firm — Cooley LLP Related U.S. Application Data (57) ABSTRACT (63) Continuation of application No. 15/001,610, filed on Jan. 20, 2016, which is a continuation of application Methods and devices are provided for targeted non-Surgical administration of a drug formulation to the Suprachoroidal (Continued) space (SCS) of the eye of a human subject for the treatment (51) Int. C. of a posterior ocular disorder or a choroidal malady. In one A6 IK 9/00 (2006.01) embodiment, the method comprises inserting a hollow A6 IK 9/10 (2006.01) microneedle into the eye at an insertion site and infusing a drug formulation through the inserted microneedle and into (Continued) the suprachoroidal space of the eye, wherein the infused (52) U.S. C. drug formulation flows within the Suprachoroidal space CPC ......... A6 IK3I/4439 (2013.01); A61K 9/0019 away from the insertion site during the infusion. In one (2013.01); A61K 9/0048 (2013.01); embodiment, the fluid drug formulation comprises drug (Continued) nanoparticles or microparticles. (58) Field of Classification Search CPC ... A61K 31/4439; A61 K 9/0048: A61 K 9/16; 13 Claims, 40 Drawing Sheets 35tawitreat 338cios eit to figst to each; 83; US 9,572,800 B2 Page 2 Related U.S. Application Data D383,049 S 9, 1997 Concari et al. 5,667,491 9, 1997 Pliquett et al. No. 14/.441,151, filed as application No. PCT/ 5,681,825 10, 1997 Lindqvist et al. 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