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Special delivery looks good
THE human eye is a truly amazing instrument. But one of its great strengths - its relative isolation from the rest of the body - is also a real problem for the treatment of eye diseases.
Delivering drugs that can treat problems at the back of the eye, such as macular degeneration, is particularly difficult.
Large and possibly toxic doses are needed when they are delivered through eye drops or intravenously.
Which is where Australian listed drug delivery company pSivida comes in.
Chief executive Dr Paul Ashton said he was "very encouraged" by a recent 12-month safety and efficacy study of its Iluvien product.
The key point about Iluvien is not the drug it contains -- well-known corticosteroid FA (fluocinolone acetonide) -- but in the manner of delivery.
The drug is contained in a tiny, slow-release device that can fit inside a needle. It is injected into the eye where it releases a very low dose of the drug over several years.
The 12-month study produced no adverse effects for low-dose patients while 23.5 per cent of high-dose patients recorded a rise in intraocular pressure.
Those figures are an improvement on earlier results recorded by Retisert, a larger insert developed by pSivida which is surgically implanted into the eye.
pSivida is also working on a nanotechnology delivery system which would be even smaller again.
Reducing side-effects is one thing, but it is treating the debilitating effect of diseases such as diabetic macular edema that is the very positive flip side.
Dr Ashton said many macular degeneration sufferers got a marked improvement.
A larger Phase 3 trial produced an improvement of 15 letters or better on a standard eye chart for 27.3 per cent on a higher dose and 23.1 per cent for the lower dose.
That sort of marked eyesight improvement is particularly important in treating patients with diabetes, who can be quite young when their vision is first affected.
One early trial patient, a young diabetic, went from being close to legally blind to getting back 20/40 eyesight.
"The main alternative treatment is with a laser and this delivery method produces much better results than that," said Dr Ashton.
The company hopes to file a new drug application with the US Food and Drug Administration next year.
Despite its innovative drug delivery technology, like most life sciences companies pSivida has come through a rocky patch on the ASX.
It licensed the only two FDA-approved, back-of-the-eye treatments for chronic eye disease to Bausch & Lomb while licensing partner Alimera Sciences is progressing the diabetic macular edema treatment.
Major shareholder Pfizer has the rights for all other opthalmic applications, which could be significant given the potential to treat other back-of-the-eye diseases.
Dr Ashton said the company was fortunate to have no debt with the prospect of significant royalty income in the short to medium term.
Last year pSivida raised $82 million from partner Alimera in exchange for increasing its equity stake in future treatment profits to 80 per cent.
