ThromboGenics NV has announced that the FDA has accepted its Investigational New Drug (IND) Application for its CIRCLE study, a Phase II, randomized, double-masked, sham-controlled, multi-center study that will evaluate the efficacy and safety of multiple doses of ocriplasmin in inducing total posterior vitreous detachment (PVD) in subjects with non-proliferative diabetic retinopathy (NPDR).
CIRCLE will evaluate JETREA® for the treatment of patients with moderately to very severe NPDR and its potential to reduce their risk of progression to Proliferative Diabetic Retinopathy (PDR). The phase II study will be conducted in clinical sites in the United States as well as in several European countries.
ThromboGenics and its clinical advisors believe that by using JETREA® to generate a PVD, the development of PDR and its sequelae may be prevented. PVD induction eliminates the scaffold for which new blood vessels may bleed into the vitreous. This belief is reinforced by the fact that the complications of PDR are less in patients who have a PVD.
A recent report from the American Academy of Ophthalmology has projected that the prevalence of individuals with vision threatening diabetic retinopathy in the United States will be around 1.34 million persons by 2020.
ThromboGenics remains on track to recruit the first patient in the United States around year-end 2015.
Dr Patrik De Haes, ThromboGenics’ CEO, said: “The FDA acceptance of our IND is a key step in our plans to develop JETREA® for patients with diabetic retinopathy, a very significant indication where there is a clear need for improved treatment options and where we believe this novel medicine can meet a major unmet medical need. Today’s FDA news also allows us to reconfirm that our Phase II CIRCLE trial in this indication remains on track to initiate around year-end.”