Eye treatment could be commercial breakthrough for ThromboGenics
Belgian biopharma company ThromboGenics could have a major product on its hands in the shape of new eye treatment.
The company has just released data from a second phase III trial of the drug, which treats vitreomacular adhesion (VMA) – a condition that causes serious eye problems such as macular hole and some forms of macular edema.
A ‘full thickness macular hole’ currently requires major eye surgery to prevent blindness, so a single intravitreal injection is a very appealing alternative for patients.
Vitreomacular adhesion is also associated with a worse prognosis in certain major eye conditions, including diabetic retinopathy and age-related macular degeneration (AMD).
The new data shows microplasmin met its primary endpoint, and also confirmed an earlier study, raising hopes that it could soon be ThromboGenics’ first drug to market.
Analysts Jeffries International forecast the drug could hit peak sales of $600 million, which would transform the fortunes of the company.
This forecast doesn’t include additional indications for the drug currently being tested in diabetic retinopathy (DR), age-related macular degeneration (AMD) and stroke, which would boost revenues further.
Dr Patrik De Haes, chief executive of ThromboGenics, said the results showed microplasmin has the potential to make a significant impact on the treatment of vitreoretinal disorders.
”Given the success of the overall phase III clinical programme, I am extremely confident that microplasmin has the potential to provide both patients and retina specialists with a highly attractive treatment option for a broad range of retinal disorders.”
Over the next few months, the data will be presented to the global retina community at a number of major international ophthalmology congresses.
The company is now building up its regulatory affairs and marketing departments in the US, and gearing up its manufacturing arrangements.
In 2009, the company made a loss of €14.1 million, but could soon see revenues rolling in if the drug gains marketing approval.
The company has two other significant drugs in its pipeline. The first of these is TB-402, a novel, long-acting anti-coagulant in phase II. The drug is being developed for the prevention of deep vein thrombosis (DVT) following orthopaedic surgery. The results of this study, which has recruited 315 patients, are due in the second quarter of 2010.
TB-402’s promise is that it requires just a single injection post surgery, which ThromboGenics believes could eventually make it part of the standard post-surgical approach to prophylaxis of DVT.
The company’s other significant candidate is TB-403, a cancer treatment that has completed its phase I studies. TB-403 was well tolerated with no reported dose limiting toxicity. Development is now set to progress, in combination with partners BioInvent and Roche.
The drug is an anti-PlGF antibody, which targets vascular endothelial growth factors (VEGF) in a similar way to Roche’s blockbuster treatment Avastin. The potential advantage of the anti-PlGF antibody is that it only targets cancer cells, and leaves blood vessels in healthy tissues unaffected.
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