Regional EuroTimes
Date Posted 17/06/2009
Pipeline filled with investigational agents for dry AMD
Experience with anti-VEGF therapies for exudative age-related macular degeneration (AMD) indicates they act as temporising agents, and so preventing significant disease-related vision loss depends ultimately on identifying therapies for treating dry AMD. Dry AMD is a target of numerous pharmacologic entities now in development.
In a morning symposium on AMD at the 17th Congress of the European Society of Ophthalmology in Amsterdam, The Netherlands, Philip Rosenfeld MD, PhD, reviewed three that are currently in clinical trials.
NT-501 (Neurotech Pharmaceuticals) is a novel intraocular implant containing ciliary neurotrophic factor (CNTF)-producing cells encapsulated in a proprietary platform that slowly releases the protein over a period of one to two years. Gram for gram, CNTF is the most powerful neuroprotective agent yet identified, and it has been shown in extensive animal testing to protect photoreceptors, explained Dr Rosenfeld, professor of ophthalmology, Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, FL.
In a randomised, double-masked, Phase 2 study including 51 eyes with vision impairment secondary to atrophic AMD, the top line result showed the highest of two CNTF doses tested significantly increased retinal volume compared with sham control. There was not a significant treatment benefit on visual acuity or evidence of an effect on geographic atrophy lesion size.
“It is clear the technology works in releasing the protein, but it is unclear if the treatment will be beneficial. However, a Phase 3 study enrolling 300 patients is planned,” said Dr Rosenfeld.
Inhibition of the complement cascade represents another strategy being investigated for the treatment of dry AMD. POT-4 (Potentia Pharmaceuticals), an inhibitor of complement component 3 (C3), is being investigated in an ongoing multicentre Phase 1 dose-escalation study with planned follow-up to one year. Injected as a liquid, POT-4 forms into a gel-like deposit in the vitreous that persists for six months to provide sustained C3 inhibition.
Patients enrolled in the Phase 1 study have advanced exudative AMD. Imaging evaluations provide evidence that POT-4 treatment suppresses edema, presumably by shutting down the production of VEGF, said Dr Rosenfeld.
Eculizumab (Soliris, Alexion Pharmaceuticals) is another complement inhibitor that is being evaluated as a treatment for dry AMD in a study enrolling patients with high-risk drusen and geographic atrophy. Currently approved in Europe and the US, this drug is administered by intravenous infusion and inhibits C5.
“Systemic therapy for AMD is probably not a viable strategy, but this is an important study because eculizumab provides a positive control for systemic inhibition of complement. If successful, it will demonstrate the importance of complement inhibition in treating AMD, although if the treatment fails, there may be a variety of reasons to explain the lack of benefit other than that complement inhibition is not affecting the disease process,” said Dr Rosenfeld.
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