According to the company, microplasmin offers a more patient-friendly and lower cost solution to the treatment of retinal disorders compared to the more traditional method of vitrectomy.
Additionally, it is thought that microplasmin may hold the potential to treat Diabetic Retinopathy (DR) and Age-related Macular Degeneration (AMD) where vitreomacular adhesion contributes to the patient’s condition.
“To treat these retinal disorders you usually need to perform eye surgery, but we can avoid the need to perform eye surgery in a third of cases, with one 125mg injection into the back of the eye” Dr Patrik De Haes, CEO of ThromboGenetics, told in-PharmaTechnologist.
ThromboGenics say the drug is the first readily manufactured form of the molecule, available on a proprietary basis, and claim “There is no similar product that we are aware of that with one injection in a lifetime, can cure retinal disorders in 40 per cent of all cases,”
Microplasmin; a truncated form of human protein plasmin
Under the agreement MSD Biologics, part of the Merck BioManufacturing network, will continue to produce bulk microplasmin, a truncated form of human protein plasmin, and a naturally occurring enzyme that dissolves protein formations, crucial to blood clot formation.
This production will take place at MSD’s Billingham, UK facility, which has been approved by the US FDA and the EMA, therefore helping ThromboGenics meet its commercial needs for bulk drug substance of the therapeutic agent.
“We’re interested in the long term supply of microplasmin,” said De Haes, adding, “This accounts for 70 per cent of the value of our company.”
ThromboGenics’ lead drug candidate has already completed two Phase III clinical trials in 650 patients in the US and Europe with vitreomacular adhesion (VMA), and resulted in “four in every ten being completely cured in terms of retinal disorders,” said De Haes.
Having declared his intentions to submit a Biologics License Application (BLA) to the FDA and Marketing Authorisation Application (MAA) to the EMA by mid-2011, De Haes suggested that microplasmin may reach the market by mid-2012, and will eventuallybe marketed at retinal surgeons and retinal specialists.