Global drug development

Iris Pharma frequently acts as a development partner, actively collaborating with clients on all stages of the drug and device development process in ophthalmology. One-stop solution brings significant benefits for our customers in terms of flexibility and efficiency.

 

CASE STUDY 1

Project: Novel gel based formulations development of anti-glaucomateous timolol.

Sponsor: Mid-size European pharma.

Iris Pharma responsibilities:

  • design and execution of the ocular pharmacokinetic
  • ocular tolerability and efficacy rabbit studies to support the identification of the optimal formulation
  • Phase I and Phase III clinical trials

Iris Pharma study directors and management worked closely with the sponsor project leader and R&D senior management. In regular teleconferences and face-to-face meetings, both sides reviewed results and progress, and mapped out quarterly plans.

In addition, to control costs and timelines, we took on the development of a reliable snapshot test, presented in part in a poster at the 2009 ARVO Annual Meeting, to rapidly screen formulations at early stages of development, instead of conducting time-consuming full ocular pharmacokinetic studies.
We recommended a formulation for ocular GLP studies that we conducted to enable a first-in-man study that we performed, followed by a phase III clinical trial.

The product is now marketed in Europe.

 

CASE STUDY 2

Project: Ganciclovir gel development for treating ocular herpes.

Sponsor: Mid-size European pharma.

Iris Pharma responsibilities:

  • ocular preclinical tolerance studies:
    • ocular irritation
    • local anesthetic effects
  • preclinical distribution studies:
    • ocular pharmacokinetic after instillation in intact and deepithelialized eyes of pigmented rabbit
    • ocular autoradiography distribution and metabolism in blood, after instillation in pigmented rabbits with intact and deepithelialized corneas
  • local tolerance of ganciclovir compared with its vehicle after repeated administrations in 10 healthy volunteers
  • kinetics of ganciclovir in tears after repeated instillations in 6 healthy volunteers

Our experienced staff conducts preclinical and clinical studies that meet client specific needs and objectives.

The product is now sold in more than 30 countries.