April 2009
Volume 50, Issue 13
ARVO Annual Meeting Abstract  |   April 2009
A Model-Based Dose-Response Meta-Analysis of Single Agent Intraocular Pressure (IOP) Therapies Used to Evaluate Efficacy of a Potential New Therapy (PF-03187207) in Glaucoma Patients
Author Affiliations & Notes
  • D. Nickens
    Pfizer, San Diego, California
  • J. Mandema
    Quantitative Solutions, Menlo Park, California
  • R. Courtney
    Pfizer, San Diego, California
  • S. Raber
    Pfizer, San Diego, California
  • C. Bosworth
    Pfizer, San Diego, California
  • Footnotes
    Commercial Relationships  D. Nickens, Pfizer, E; J. Mandema, Quantitative Solutions, E; R. Courtney, Pfizer, E; S. Raber, Pfizer, E; C. Bosworth, Pfizer, E.
  • Footnotes
    Support  Supported by Pfizer Inc.
Investigative Ophthalmology & Visual Science April 2009, Vol.50, 2479. doi:
  • Views
  • Share
  • Tools
    • Alerts
      This feature is available to authenticated users only.
      Sign In or Create an Account ×
    • Get Citation

      D. Nickens, J. Mandema, R. Courtney, S. Raber, C. Bosworth; A Model-Based Dose-Response Meta-Analysis of Single Agent Intraocular Pressure (IOP) Therapies Used to Evaluate Efficacy of a Potential New Therapy (PF-03187207) in Glaucoma Patients. Invest. Ophthalmol. Vis. Sci. 2009;50(13):2479.

      Download citation file:

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

  • Supplements

Purpose: : Evaluate/characterize the dose-response of PF-03187207 (PF-207) for IOP using a model-based meta-analysis of single agent IOP therapies including prostaglandin analogues and timolol.

Methods: : Summary level data of randomized controlled clinical trials from published literature, FDA regulatory documents and sponsor reports were used to create a database of single agent IOP lowering compounds. An Emax model was used to characterize the efficacy (IOP change from baseline) profile of the compounds and was evaluated as a function of dose, time of day, time of dose administration (QAM, QPM, BID) and baseline IOP. The models were subsequently updated with data on PF-207 from a dose-ranging (0.003% to 0.04%), active-controlled (latanoprost 0.005%), randomized, double-masked, parallel-group study in adult subjects with primary open-angle glaucoma or ocular hypertension.

Results: : The meta-analysis database included 31 trials with summary data on 6516 patients on 30 unique treatment regimens for bimatoprost, latanoprost, travoprost, timolol and placebo. Placebo response was estimated at -2.01 mmHg (baseline IOP 25 mmHg). No significant difference was found in the Emax (estimated at -6.27 mmHg) of the prostaglandin analogues (baseline IOP 25 mmHg). QPM administration had greater IOP reduction when compared to QAM or BID. Values of median effective dose (ED50,%/day) for IOP were estimated as 0.36%, 0.002%, 0.00098%, and 0.00062% for timolol, bimatoprost, latanoprost and travoprost, respectively. The updated model included PF-207 data for 215 randomized patients. ED50 and Emax values for PF-207 were estimated to be 0.0054%/day and -6.90 mmHg, respectively.

Clinical Trial: : www.clinicaltrials.gov NCT00441883

Keywords: clinical (human) or epidemiologic studies: biostatistics/epidemiology methodology • intraocular pressure 

This PDF is available to Subscribers Only

Sign in or purchase a subscription to access this content. ×

You must be signed into an individual account to use this feature.