title: Bimatoprost Sustained-Release Implants for Glaucoma Therapy: 6-Month Results From a Phase I/II Clinical Trial.
abstract: OBJECTIVE
  To evaluate the safety and intraocular pressure (IOP)-lowering effect of a biodegradable bimatoprost sustained-release implant (Bimatoprost SR).
  
  
  METHODS
  Phase I/II, prospective, 24-month, dose-ranging, paired-eye controlled clinical trial.
  
  
  METHODS
  At baseline following washout, open-angle glaucoma patients (n = 75) were administered Bimatoprost SR (6 μg, 10 μg, 15 μg, or 20 μg) intracamerally in the study eye; the fellow eye began topical bimatoprost 0.03% once daily. Rescue topical IOP-lowering medication or a single repeat treatment with implant was allowed. The primary endpoint was IOP change from baseline. The main safety measure was adverse events. Results through month 6 are reported.
  
  
  RESULTS
  Bimatoprost SR provided rapid, sustained IOP lowering. Overall mean IOP reduction from baseline through week 16 in study eyes was 7.2, 7.4, 8.1, and 9.5 mm Hg with the 6-μg, 10-μg, 15-μg, and 20-μg dose strengths of implant, respectively, vs 8.4 mm Hg in topical bimatoprost-treated pooled fellow eyes (data censored at rescue/retreatment). Rescue/retreatment was not required in 91% and 71% of study eyes up to week 16 and month 6, respectively. Adverse events in study eyes usually occurred within 2 days after the injection procedure and were transient. Conjunctival hyperemia with onset later than 2 days after the injection procedure was more common with topical bimatoprost than Bimatoprost SR (17.3% vs 6.7% of eyes).
  
  
  CONCLUSIONS
  Bimatoprost SR demonstrated favorable efficacy and safety through 6 months. All dose strengths were comparable to topical bimatoprost in overall IOP reduction through week 16. A single administration controlled IOP in the majority of patients for up to 6 months.
authors.affiliation: Sacramento Eye Consultants, Sacramento, California. Electronic address: rlewiseyemd@yahoo.com.
authors.forename: Richard A
authors.initials: RA
authors.lastname: Lewis
authors.affiliation: Scott & Christie and Associates, Pittsburgh, Pennsylvania.
authors.forename: William C
authors.initials: WC
authors.lastname: Christie
authors.affiliation: Coastal Research Associates, Roswell, Georgia.
authors.forename: Douglas G
authors.initials: DG
authors.lastname: Day
authors.affiliation: Wilmer Eye Institute, Baltimore, Maryland; King Khaled Eye Specialists Hospital, Riyadh, Saudi Arabia.
authors.forename: E Randy
authors.initials: ER
authors.lastname: Craven
authors.affiliation: Keystone Research, Ltd, Austin, Texas.
authors.forename: Thomas
authors.initials: T
authors.lastname: Walters
authors.affiliation: Allergan plc, Irvine, California.
authors.forename: Marina
authors.initials: M
authors.lastname: Bejanian
authors.affiliation: Allergan plc, Irvine, California.
authors.forename: Susan S
authors.initials: SS
authors.lastname: Lee
authors.affiliation: Allergan plc, Irvine, California.
authors.forename: Margot L
authors.initials: ML
authors.lastname: Goodkin
authors.affiliation: Allergan plc, Bridgewater, New Jersey.
authors.forename: Jane
authors.initials: J
authors.lastname: Zhang
authors.affiliation: Allergan plc, Irvine, California.
authors.forename: Scott M
authors.initials: SM
authors.lastname: Whitcup
authors.affiliation: Allergan plc, Irvine, California.
authors.forename: Michael R
authors.initials: MR
authors.lastname: Robinson
mesh_terms: D020341:Absorbable Implants; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000959:Antihypertensive Agents / Q000008:administration & dosage; D000069580:Bimatoprost / Q000008:administration & dosage*; D003692:Delayed-Action Preparations; D004311:Double-Blind Method; D004343:Drug Implants; D005260:Female; D005500:Follow-Up Studies; D005902:Glaucoma, Open-Angle / Q000188:drug therapy* / Q000503:physiopathology; D006801:Humans; D007429:Intraocular Pressure / Q000187:drug effects*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011474:Prosthesis Design; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000959:Antihypertensive Agents; D003692:Delayed-Action Preparations; D004343:Drug Implants; D000069580:Bimatoprost