Related Area
One-stop shop solution
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.
- preclinical development (proof-of concept, GLP studies, in vivo models)
- preclinical formulation
- bioanalytical testing services
- clinical services (phase I, phase II, phase III, phase IV, post-marketing surveys)
- strategic consulting in the ocular drug development process.
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.
