Bausch + Lomb, the eye health major, has initiated late-stage trials of latanoprostene bunod (previously known as BOL-303259-X and NCX 116), which is licensed from France's Nicox, for the reduction of intraocular pressure in patients with glaucoma or ocular hypertension.
Latanoprostene bunod is a nitric oxide-donating prostaglandin F2-alpha analogue and will be evaluated in two Phase III studies, which will include approximately 800 patients. The primary endpoint is the reduction in mean IOP measured at specified time points during three months of treatment.
The move into late-stage studies follows promising Phase IIb data in 413 patients which showed that latanoprostene bunod at all four doses showed greater IOP reduction compared with Pfizer's Xalatan (latanoprost); the differences for two of the four doses reached statistical significance.
Cal Roberts, B + L's chief medical officer, said the drug "has the potential to become an important new treatment option for people suffering from elevated IOP due to glaucoma and ocular hypertension". Nicox chairman Michele Garufi noted that this is the company's first treatment licensed to a partner to enter into Phase III and "we are pleased with B + L's commitment to pursuing this programme in an area of significant therapeutic need".
The drug was originally licensed to Pfizer but the rights were bought back by Nicox in August 2009 and snapped up by B + L in March 2010, The Sophia Antipolis-based group stands to bank $162.5 million, plus tiered double-digit royalties and has the option to co-promote in the USA.