September 2016
Volume 57, Issue 12
Open Access
ARVO Annual Meeting Abstract  |   September 2016
Bimatoprost Sustained-Release Implants for Glaucoma Therapy: 12-Month Interim Results From a Phase 1/2 Clinical Trial
Author Affiliations & Notes
  • Shamira Perera
    Glaucoma , Singapore National Eye Centre, Singapore, Singapore
  • Richard A. Lewis
    Sacramento Eye Consultants, Sacramento, California, United States
  • William C Christie
    Scott & Christie and Associates, Pittsburgh, Pennsylvania, United States
  • Douglas G Day
    Coastal Research Associates, Roswell, Georgia, United States
  • E R Craven
    Wilmer Eye Institute, Baltimore, Maryland, United States
    King Khaled Eye Specialists Hospital, Riyadh, Saudi Arabia
  • Marina Bejanian
    Allergan plc, Irvine, California, United States
  • Susan S Lee
    Allergan plc, Irvine, California, United States
  • Margot L Goodkin
    Allergan plc, Irvine, California, United States
  • Jane Zhang
    Allergan plc, Bridgewater, New Jersey, United States
  • Michael R Robinson
    Allergan plc, Irvine, California, United States
  • Footnotes
    Commercial Relationships   Shamira Perera, Alcon (R), Allergan (C), Ellex (R), Ivantis (F); Richard Lewis, Aerie (C), Alcon Laboratories, Inc. (C), Allergan (C), Aquesys (C), AVS (C), Envisia (C), Glaukos Corporation (C), Ivantis (C), Oculeve (C), PolyActiva (C), ViSci (C), Zeiss (C); William Christie, Abbott Medical Optics Inc (C); Douglas Day, Allergan (C); E Craven, Alcon Laboratories, Inc. (C), Alcon Laboratories, Inc. (R), Allergan (C), Allergan (R), Allergan (F), Ivantis (F), Pfizer (C), Transcend Medical (F); Marina Bejanian, Allergan plc (E); Susan Lee, Allergan plc (E); Margot Goodkin, Allergan plc (E); Jane Zhang, Allergan plc (E); Michael Robinson, Allergan plc (E)
  • Footnotes
    Support  Allergan plc
Investigative Ophthalmology & Visual Science September 2016, Vol.57, No Pagination Specified. doi:
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      Shamira Perera, Richard A. Lewis, William C Christie, Douglas G Day, E R Craven, Marina Bejanian, Susan S Lee, Margot L Goodkin, Jane Zhang, Michael R Robinson; Bimatoprost Sustained-Release Implants for Glaucoma Therapy: 12-Month Interim Results From a Phase 1/2 Clinical Trial. Invest. Ophthalmol. Vis. Sci. 201657(12):.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose : A biodegradable bimatoprost sustained-release implant (BimSR) has been developed to address the problem of nonadherence to topical intraocular pressure (IOP)-lowering medication in the glaucoma population. This study evaluates the safety and IOP-lowering effect of BimSR.

Methods : Ongoing, phase 1/2, prospective, 24-month, dose-ranging, paired-eye trial in patients with open-angle glaucoma. After washout of previous IOP-lowering medication, patients (n=75) received an intracameral injection of BimSR (6, 10, 15, or 20 µg Generation 2 formulation) in the study eye and initiated topical bimatoprost 0.03% QD (bim) in the fellow eye. Rescue topical medication or a single repeat treatment with BimSR was allowed for failure to attain target IOP or <20% reduction in IOP, respectively, on consecutive visits ≥1 week apart, or if in the patient's best interest. The primary efficacy endpoint was IOP reduction from baseline. Safety measures included adverse events (AEs).

Results : BimSR provided rapid, sustained IOP lowering (Figure). Overall mean IOP reduction from baseline through week 16 (data censored at rescue/retreatment) was 7.2, 7.4, 8.1, and 9.5 mm Hg with the 6, 10, 15, and 20 µg dose strengths of BimSR and 8.4 mm Hg in pooled fellow eyes. BimSR controlled IOP without rescue/retreatment in 99%, 91%, 65%, and 41% of study eyes up to 4 weeks, 16 weeks, 7.5 months, and 12 months, respectively (Figure). At month 12, mean IOP reduction from baseline in study eyes ranged from 5.4 mm Hg (6 µg BimSR) to 9.0 mm Hg (20 µg BimSR) vs 8.2 mm Hg in pooled fellow eyes (data censored at rescue/retreatment). Conjunctival hyperemia was the most common ocular AE; in study eyes, it usually occurred within 2 days after the injection procedure and was transient. Conjunctival hyperemia with onset more than 2 days after the injection procedure was more common with topical bim than BimSR (21.3% vs 9.3% of eyes). Eyelash growth was reported in 5 (6.7%) fellow eyes and no study eyes.

Conclusions : All BimSR dose strengths were comparable with topical bim in overall IOP reduction through week 16. A single dose of BimSR controlled IOP up to 12 months in 41% of patients. BimSR was well tolerated; most AEs occurred soon after the injection procedure and were transient. The results support further clinical development of BimSR, and phase 3 trials are in progress.

This is an abstract that was submitted for the 2016 ARVO Annual Meeting, held in Seattle, Wash., May 1-5, 2016.

 

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