New European approvals for Sinclair

Godalming UK-based Sinclair Pharma has received European Union regulatory approval for a new ophthalmology product for dry eye syndrome and two new line extension products in its key therapeutic areas of oral health and dermatology.

In the EU, its new drug for dry eye, SPHP700, has been approved as a Medical Device Class I (sterile). Sinclair noted that the current market leader in prescription dry eye products in the USA achieves annual sales of $100.0 million.

In addition, Decapinol Spray, a new presentation of Sinclair's gingivitis product Decapinol Rinse, which is already approved in the EU and USA, is now approved in the EU as a Medical Device Class IIa. Atopiclair Fluid, a new formulation of Sinclair's dermatitis drug Atopiclair, a hydrolipidic cream indicated for eczema and allergic skin reaction, was also cleared in the EU as a Medical Device Class IIa.