ThromboGenics NV, an integrated biopharmaceutical company focussed on developing and commercialising innovative ophthalmic medicines, announces that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for a new ready-diluted formulation of Jetrea (ocriplasmin).

Jetrea is approved in the EU for the treatment of vitreomacular traction (VMT), including when associated with macular hole of diametre less than or equal to 400 microns. VMT is an age-related progressive, sight-threatening condition that may lead to visual distortion, decreased visual acuity and central blindness.

The introduction of the new formulation of Jetrea will eliminate the preparatory dilution steps prior to injection. At the point of administration into the eye, the strength, potency, composition and pharmaceutical form of the ready-diluted formulation remain identical to the currently available formulation after dilution.

Dr. Patrik De Haes, chief executive officer, of ThromboGenics, says, “We are very pleased that the CHMP has provided a positive recommendation for our new ready-diluted formulation of Jetrea. With this new formulation, it will be easier and more convenient for retina physicians to use this novel pharmacological option for the treatment of patients with VMT. We anticipate a final approval decision from the European Commission within the next 2 to 3 months paving the way for the eventual introduction of this new formulation across all 28 European Union Member States plus Iceland and Norway.”

ThromboGenics’ partner Alcon, who is commercialising Jetrea outside the US, will be responsible for planning the launch of the new ready-diluted formulation.