September 2016
Volume 57, Issue 12
Open Access
ARVO Annual Meeting Abstract  |   September 2016
Topline Results From Prospective, Double-masked, Placebo Controlled Phase 2 Clinical Study Evaluating Luminate® (ALG-1001) in Patients with Symptomatic Focal Vitreomacular Adhesion
Author Affiliations & Notes
  • Baruch D Kuppermann
    Ophthalmology, Gavin Herbert Eye Institute, Irvine, California, United States
  • David S Boyer
    Retina Vitreous Associates, Los Angelos, California, United States
  • Peter K Kaiser
    Ophthalomology, Cole Eye Institute, Cleveland, Ohio, United States
  • Jeffrey S Heier
    Ophthalmic Consultants of Boston, Boston, Massachusetts, United States
  • Peter A Campochiaro
    Ophthalmology, Wilmer Eye Institute, Baltimore, Maryland, United States
  • Hugo Quiroz-Mercado
    Ophthalmology, University of Colorado, Denver, Colorado, United States
  • Julia Kornfield
    Chemical Engineering, California Institute of Technology, Pasadena, California, United States
  • Lisa Karageozian
    Allegro Ophthalmics, LLC, San Juan Capistrano, California, United States
  • Mohamed A Genead
    Allegro Ophthalmics, LLC, San Juan Capistrano, California, United States
  • Hampar L Karageozian
    Allegro Ophthalmics, LLC, San Juan Capistrano, California, United States
  • Vicken H Karageozian
    Allegro Ophthalmics, LLC, San Juan Capistrano, California, United States
  • Footnotes
    Commercial Relationships   Baruch Kuppermann, Alimera (C), Allegro (C), Allergan (C), Genentech (C), Glaukos (C), GSK (F), Novartis (C), Ophthotech (C), Regeneron (C), ThromboGenics (C); David Boyer, Allegro Ophthalmics (C); Peter Kaiser, Allegro Ophthalmics (C); Jeffrey Heier, Allegro Ophthalmics (C); Peter Campochiaro, Allegro Ophthalmics (C); Hugo Quiroz-Mercado, Allegro Ophthalmics (C); Julia Kornfield, Allegro Ophthalmics (C); Lisa Karageozian, Allegro Ophthalmics (C); Mohamed Genead, Allegro Ophthalmics (E); Hampar Karageozian, Allegro Ophthalmics (E); Vicken Karageozian, Allegro Ophthalmics (E)
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science September 2016, Vol.57, No Pagination Specified. doi:
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      Baruch D Kuppermann, David S Boyer, Peter K Kaiser, Jeffrey S Heier, Peter A Campochiaro, Hugo Quiroz-Mercado, Julia Kornfield, Lisa Karageozian, Mohamed A Genead, Hampar L Karageozian, Vicken H Karageozian; Topline Results From Prospective, Double-masked, Placebo Controlled Phase 2 Clinical Study Evaluating Luminate® (ALG-1001) in Patients with Symptomatic Focal Vitreomacular Adhesion. Invest. Ophthalmol. Vis. Sci. 201657(12):.

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      © 2017 Association for Research in Vision and Ophthalmology.

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Abstract

Purpose : To investigate the safety and efficacy of Luminate (ALG-1001), a synthetic anti-angiogenic and vitreolytic oligopeptide, administered intravitreally in patients with focal vitreomacular adhesion (VMA) or vitreomacular traction (VMT).

Methods : Patients were randomly assigned to four groups. Group 1 received intravitreal Luminate 2.0 mg, Group 2 received Luminate 2.5 mg, Group 3 received Luminate 3.2 mg, and Group 4 (control) received an intravitreal injection of balanced salt solution. Intravitreal injections were administered monthly until VMA or VMT release was achieved for a total of 90 days with three maximum injections. VMA or VMT release was determined by optical coherence tomography (OCT) images read by Duke Reading Center. The primary endpoint of this study was observation of pharmacologic resolution of VMA by OCT, with VMA defined as vitreous adhesion to the macula within a 6mm central retinal field determined on OCT.

Results : One hundred and six patients from approximately 20 sites in the United States and Europe were included in this analysis. Sixty-five percent of patients treated with the 3.2 mg dose of Luminate achieved release of VMA or VMT by Day 90 (p=0.0129), compared to 21% of those in the 2.5 mg group, 23% in the 2.0 mg group, and 10% of those in the placebo control group. For all groups, 48% of all releases occurred after the first injection, 32% occurred after the second injection, and 20% of all releases occurred after the third injection. The most commonly reported AEs were conjunctival hyperemia and sub-conjunctival hemorrhage at the injection site. There was no incidence of drug toxicity or significant intraocular inflammation, no afferent pupillary defects, and no evidence of retinal tears or detachments among all groups.

Conclusions : Data from this phase 2 VMA/VMT trial demonstrated that Luminate met its primary endpoint of VMA or VMT release. Luminate was well-tolerated in all Luminate dosing groups.

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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