Road map
Next steps
In vivo testing
01.
Pre-clinical test – animal testing:
The first stage of this study will be done with InEye® placebo (without drugs) on pets to validate this technology for veterinary use. The goals of this study are the assessment of the safety and suitability of the technology, i.e., the tolerability, the toxicity, the accidental expulsion and other events directly or indirectly related with the use of the insert.
A second stage will include rabbits as animal model.
02.
Clinical test with placebo:
The tests will be performed on healthy volunteers prior to the Phase II Clinical Trials with InEye® containing drugs for a specific treatment. This study’s outcome will be the last proof of concept before the evaluation of the in vivo drug release kinetics and the corresponding therapeutic effect in comparison with the standard treatment with eye drops.
Scale-up
01.
Polymer synthesis:
With the critical process parameters defined for the polymer synthesis, we are now ready to increase the batch size to pilot production scale. We will use the most accurate, reliable and fast production process, with the adequate in-process controls considering the polymer critical quality attributes for the intended use, with minimum waste and through solvent-free processes.
02.
InEye® manufacturing:
Knowing the quality target product profile for InEye®, different production lines following a quality-by-design strategy are being planned.
The production of GMP batches will be mandatory for the clinical trials.
