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Re: DewDiligence post# 6870

Friday, 01/21/2005 3:52:14 AM

Friday, January 21, 2005 3:52:14 AM

Post# of 257302
isolution: What is your opinion of the InnoRx device?

In the family of local delivery for the eyes, there is the implant subgroup, ie CDS/B&L with Vitrasert (non biodegradable intravitreal implant), Oculex/Allergan with Posurdex (biodegradable implant inserted into anterior or posterior chamber) and InnoRx (coated device implanted through the sclera).

None of these is a miracle solution as always.
First point to adress is to find a stable drug to be incorporated into these devices. It is a good point to be able to achieve more or less constant drug release over extended period of time, but the drug itself has to be stable over this period. This unfortunatly exclude a lot of interesting drug. Drug stability is one of the main issue.

Second point is the formulation work to do to link the drug to the implant. Vitrasert is the easiest for it is a small container, InnoRx based on Surmodics technology and background seems also fine, also for the drug is simply mixed with a matrix, and similar to Allergan that is less experimented. But sometime, for various ingredient incompatibility, formulation can be very complicated.

Third point is surgical placement, InnoRx device seems to be the easiest, Allergan is quite simple also, the worse is B&L for you have to reopen every once in a while to replace/remove the implant. Every time you puncture an eye you have the known risks of bleeding, retinal detachment and endophtalmitis.

Fourth point is side effect of the implant. Once implanted, I don't see much problem with Allergan and B&L except inflammatory reaction due to natural immune system, also some local inflammation due to the sutures (except if the implant carry an antiinflammatory) that can potentially lead to small neovascularisation. The major hurdle for me is the InnoRx. I was interested for a while with the catheter business which are inserted into the circulation. Long-term catheter have well-know side-effect mostly due to the puncture created by the catheter that leads to infections (path between catheter outside diameter and tissues like skin) and leaks (after a certain period of time, tissues surrounding the catheter get loose their elasticity). On that point, I feel very much concerned with InnoRx corkscrew, especially when you know that sclera is not elastic.

Fifth point is side effect due to the drug itself. Long term local realase of certain drug lead to local side-effects as it applies for the whole body. For example, corticoids lead to cataract and IOP rise. The ability to control or modulate the delivery can be an advantage. None of the implants are capable of some modulation without having to remove it.

To conclude, InnoRx implant looks very interesting but definitively less sexy when presented this way.

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