Irritation test - Dermal Filler - 52-week implantation study

#1
All,

For the Irritation test, it is common to observe the erythema / edema for 3 days after injection of the filler into the rabbit according to the ISO10993-10 guidelines.

In the case of high viscoelastic materials such as our products, the initial irritation is severe and long-term. Therefore, it is known that the period of irritation is measured by adjusting the test period and observing for 2 to 4 weeks.

In the 2017 FDA-approved Teoxane RHA4 filler, no irritation was observed 26 days after injection and a 52-week implantation study confirmed the onset of degradation.

Our nonclinical development department commented that our products could also be requested for data on systemic toxic effects during irritation if the irritation result is similar to RHA4 and lasts for 4 weeks and then decreases It is judged.

The nonclinical development team comments that our products can also be requested for data on local and system effects during irritation if the irritation results are similar to RHA4 for 4 weeks and then decreased.

In addition, from the results of our product's efficacy test, which remained without size change for more than 6 months under the skin, we need an additional 52-week implantation study to confirm the degradation.

We are planning to prepare a dossier for CE certification.

Would it be better to do the 52-week implantation study to moniter the degradation? (Kindly share any regulation or guideline for me)

Thank you for your help in advance.
 
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