Ophthalmic - Contact Lens / Lens Care Products
The global nonclinical development of contact lens and contact lens care products is a challenging and multi-faceted endeavor, and one in which iuvo BioScience is uniquely positioned to provide consulting services and testing. Our team is experienced in development of nonclinical testing strategies, testing conduct, and preparation of regulatory submissions for daily wear and extended wear contact lenses, multipurpose contact lens care products, contact lens rewetting drops, as well as ancillary contact lens care products.
We are poised to work with you in multiple ways:
Screening Assays: Early during the development of your contact lens or contact lens care product, you may want a screening assessment to support further development. iuvo BioScience has a number of in vitro and in vivo screening assays designed specifically for rapid execution and expedient reporting to help provide the answers you need.
Biocompatibility: iuvo can provide guidance in the development of your biocompatibility assessment strategy according to the requirements of ISO 10993-1: 2009 (Cor Amd 1:2010). In addition to the core testing recommended by ISO 10993-1, iuvo also conducts the 22-day contact lens study in rabbits (ISO 9394:2013; MHLW), and the newly required cytotoxicity testing of contact lenses in combination with lens care solutions (ISO 18189:2016). More information on the ISO 10993-1 requirements are available here.
Contact Lens Care Product Performance Testing: A critical part of contact lens care product is demonstrating efficacy in accordance with the requirements of ISO 14729:2001 (Amd 1:2010) (regimen testing) and ISO 14730:2014 (antimicrobial preservative efficacy testing). iuvo’s microbiology team has established these rigorous studies for comprehensive testing with all required organisms.
Analytical Chemistry for Contact Lens Care Products: In the process of developing contact lens care products, specification for key product attributes, for example disinfectant levels, must be developed. The analytical chemistry team has the experience and expertise to help develop the methods and provide the analytical services to assure the quality of your product.
Contact Lens Care Product Stability Assessment: Similar to pharmaceutical products, contact lens care product are required to undergo rigorous testing for stability including various temperature/humidity settings and bottle orientation. The iuvo team can help design and execute your stability study, including performing analytical chemistry for determination of disinfectant levels and microbiology testing to assess product performance. More information on our stability servicers are located here.