Biovitrum has initiated phase I trials for its glaucoma drug candidate that aims to improve over existing current treatments and satisfy the need in the market for new drugs with novel active mechanisms of action.
Glaucoma is a disease characterized by damage to the optic nerve and it is in most cases accompanied by an increased pressure within the eye. The disease leads to gradually impaired vision and blindness.
Glaucoma is the most common cause of blindness in the industrialised world. Biovitrum's glaucoma drug provided as eye-drops aims at lowering the intraocular pressure by increasing the outflow of aqueous humour.
The drugs currently used against glaucoma have limitations and combination therapies are common. For a large proportion of patients, surgical intervention is necessary when drug treatment fails to provide sufficient effect.
The clinical trials in Phase I include about 60 healthy volunteers and the study is scheduled to be completed during autumn 2005 with results available early next year.
A spokesman for BioVitrum told DrugResearcher.com: "The general opinion is that there is need in the market for new antiglaucoma agents if the compounds are well tolerated with a minimum of side effects."
"BVT 28949 has been shown to be effective in lowering intraocular pressure (IOP) by increasing the outflow facility acting on new targets. In addition the drug has exhibited neuroprotective potential," he added.
BVT 28949 is a specific and selective 5HT2a-receptor antagonist that increases aqueous humour outflow. While BVT 28949 is intended for primary open angle glaucoma (POAG), Biovitrum's scientists think that normotensive glaucoma can be treated by also lowering the IOP.
The spokesman added: "There are several drugs in use for the treatment of glaucoma. Latanoprost (xalatan), by Pfizer has in a short time become the golden standard for treatment. All drugs are effective, at least in most patients, for some time and/or in combination."
Glaucoma is the most frequent cause of blindness. The pharmaceuticals currently used against glaucoma are limited and combination therapies are common. For many patients, it is necessary to resort to surgery when the effects of drug treatment are insufficient.
Consequently, there is a need in the market for new drugs with new active mechanisms. As many as 60 million people are thought to suffer from glaucoma.
The market is growing by 10 per cent annually and is expected to reach a value of $4 billion (€3.2 billion) in 2010. Two therapeutic principles are applied in the treatment of glaucoma: inhibiting the production of aqueous humour or the reinstatement of its outflow.
New pharmaceuticals are being developed by Allergen, Alcon, InSite, Vision, Acadia, Santen and Sankyo.