Norway-based speciality pharmaceutical firm Photocure has reported positive results from a Phase III trial of Blue Light Flexible Cystoscopy (BLFC) with Cysview/Hexvix to detect patients at risk of bladder cancer recurrence.
Based on the firm’s photodynamic technology, Cysview is an optical imaging agent developed to improve the diagnosis and management of non-muscle invasive bladder cancer.
While Cysview is the tradename of the agent in Canada and the US, it is marketed under the brand name Hexvix in Europe.
The agent is selectively taken up by the bladder cancer cells and emits a bright pink glow during BLC.
The results indicated that the trial met the primary endpoint, which was to see a statistically significant improvement in the detection.
Carried out in a surveillance setting, the prospective, open, comparative, within-patient controlled Phase III compared the BLC+Cysview/Hexvix with white light (WL) alone in 304 patients in the US.
Photocure president and chief executive officer Kjetil Hestdal said: “We are very pleased with the strong results of this Phase III study and we appreciate the work from investigators and patients who participated in the study.
“There are approximately 1.4 million surveillance cystoscopies performed in the US annually. These results represent an important milestone for the potential improvement in the management of patients.
“Later this year, we intend to submit the data to the US Food and Drug Administration (FDA) to seek a label expansion for the indication of BLFC with Cysview in the surveillance setting.”
In addition to enhanced detection, BLC with Hexvix is claimed to result in complete resection, less residual tumours, and a decrease in the risk of recurrence and progression.