Who We Are

A leading global contract research organization (CRO) focusing exclusively on ophthalmology.

Iris Pharma has expertise in all ophthalmic indications, and supports clients ranging from small start-ups to large pharmaceutical companies and from newcomers to experts in eye therapy. We work to move forward products that directly or indirectly affect eye health. We support our clients in every step of the process – from preclinical studies to clinical development – ensuring that the preclinical development program supports the intended clinical trial design and therapeutic use.

History

The origins of Iris Pharma date back to the late 1980s. Founder Dr. Pierre-Paul Elena – a former research officer at the France-based Laboratoires Dulcis-Allergan, which specialized in ophthalmic prescription drugs – identified a niche in the field of ocular drug development and recognized the pharmaceutical industry's growing need for preclinical outsourcing. Thus, Dr. Elena founded Iris Pharma as a contract research organization (CRO) in 1989.

Over the years, Iris Pharma has emerged as a worldwide leader in ocular drug and device development. Today Iris Pharma has nearly 70 scientists, veterinarians, ophthalmologists, pharmacists, and highly qualified staff working at two sites in La Gaude and Paris, France.

 

Expert Network & Partnerships

Iris Pharma relies primarily on our expert staff and our own laboratory and animal housing facilities in order to deliver the most flexibility and efficiency at all stages of the drug and device development process.

Nevertheless, during our 25 years in the field of ophthalmology, we have built solid relationships with key opinion leaders, internationally renowned ophthalmologists and pharmacologists, and well-established investigative sites. We have also made several strategic alliances and partnerships with internationally respected companies, in order to:

  • Offer international clinical trials when requested
  • Deliver quality work in a shortened timeline, as needed
  • Provide services related to our core business such as data management, pharmacovigilance, and systemic toxicokinetics studies

 

 The expert network is critical for our clients to achieve success in launching new ophthalmic drugs and devices.

 

Case Studies

Iris Pharma has facilitated the translation of 45 ocular drugs and medical devices from the laboratory to marketing approval - in Europe and the United States - for glaucoma, dry eye, ocular inflammation, infection and allergy. These two case studies illustrate our collaboration on all stages of the drug and device development process in ophthalmology. 

 

Novel gel-based formulations: Development of anti-glaucomateous timolol

Sponsor: Mid-size European pharmaceutical company

Iris Pharma responsibilities:

  • design and execution of the in vivo 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's 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, Iris Pharma 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.

 

Ganciclovir (GCV) gel development for treating acute herpetic keratitis

Sponsor: Mid-size International pharmaceutical company.

Iris Pharma responsibilities:

  • ocular preclinical tolerance of GCV gel when applied topically to the eye, evaluated in animals for:
    • ocular irritation
    • local anesthetic effects
  • preclinical distribution through the anterior segment disease-targeted ocular tissues after topical application of GCV gel:
    • ocular pharmacokinetic after application in intact and de-epithelialized eyes of pigmented rabbit
    • ocular autoradiography distribution and metabolism in blood, after application in pigmented rabbits with intact and de-epithelialized 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 conducted preclinical and clinical studies with an anti-viral therapy that met client specific needs and objectives.

The product is now sold in more than 30 countries within Europe, Asia, Africa, and North America.

 

Quality Assurance

Iris Pharma is developing and implementing quality management systems focused on continual improvement and efficiencies, as well as customer satisfaction. A dedicated team oversees the effectiveness of these systems, evaluating and confirming that the services provided by Iris Pharma are carried out in compliance with applicable guidelines and regulations -- including Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) --  and with customers' expectations.

Each year, more than 100 quality assurance audits are carried out for internal purposes, including audits of subcontractors and providers. 

 

 Since 1995, Iris Pharma has been satisfactorily inspected by the French competent authority (ANSM) every two years with regards to GLP compliance.

quality assurance