A new fluorescent imaging agent to assist detection of papillary cancer of the bladder has been adopted by Thomas Jefferson University Hospital in the USA.

Cysview (known in Europe as Hexvix) is licensed by GE Healthcare from Norwegian company Photocure ASA.

Used with patients who are known or suspected to have bladder cancer, it guides blue light fluorescence cytoscopy (pictured), which highlights cancerous lesions in the bladder.

The use of Cysview for cytoscopy has been shown to improve surgical outcomes relative to standard white light cytoscopy alone.

Bladder cancer, most commonly caused by smoking, is the fourth most common type of cancer in men and the eighth most common in women.

“Bladder cancer is difficult to detect,” said Dr Leonard Gomella, Associate Director for Clinical Affairs at the Kimmel Cancer Center at Thomas Jefferson University Hospital. “A missed diagnosis can result in delayed or incomplete treatment, which may lead to serious complications and a lower chance of survival.

“Cysview represents an important advance in diagnostic technology, enabling more accurate diagnosis of bladder tumours compared to the standard technique. By facilitating early diagnosis of bladder cancer, this innovative imaging agent can enable appropriate, timely treatment that may improve patients’ chances of survival.”

The FDA has approved Eli Lilly’s Cialis (tadalafil) to treat men with signs and symptoms of Benign Prostatic Hyperplasia (BPH) and Erectile Dysfunction (ED).

The drug works by inhibiting the phosphodiesterase type 5 enzyme (PDE5), helping to produce vascular relaxation and increase blood flow to the penis. These enzymes are also found in the prostate and bladder, where problems can occur with BPH.

Claus Roehrborn, Chairman of the Department of Urology at The University of Texas Southwestern Medical Centre, said: “Since many men who have ED also experience the signs and symptoms of BPH, a single medication approved to treat both may be a significant therapeutic option for men and physicians.”

The approval totals three indications: both ED and signs and symptoms of BPH separately, as well as for men who have both conditions.

Dave Ricks, Lilly USA President, said: “These additional indications for Cialis reinforce our commitment to providing medical innovation in the area of men's health.”

“We're encouraged that Cialis provides a new treatment option for men affected by both ED and the signs and symptoms of BPH,” commented Mr Ricks.

The FDA clearance was based on clinical research gathered from three placebo-controlled efficacy and safety studies involved 1,989 men.

BPH is a condition where the prostate enlarges, which can cause urinary problems. Approximately 50% of men between 40-70 years old suffer from erectile dysfunction. Several studies have shown that many men with ED also experience the symptoms of BPH.

Allergan has received FDA approval for prescription-only Botox (onabotulinumtoxinA) for injection to treat urinary incontinence.

The drug is intended to treat urinary incontinence resulting from neurogenic bladder due to stable sub-cervical spinal cord injury (SCI) or multiple sclerosis (MS) in adults who are intolerant to anticholinergic medication.

Scott Whitcup, Executive Vice President and Chief Scientific Officer at Allergan, said that Botox is the first neurotoxin to receive FDA approval for urinary incontinence.

The approval was based on results from two Phase II clinical trials, which demonstrated reductions in the frequency of episodes of urinary incontinence in patients treated with 200 Units of Botox neurotoxin compared to placebo within a two week period.

The drug recently received a positive opinion from the Irish Medicines Board for the same indication, with plans to gain approval in all 14 European Countries involved in the Mutual Recognition Procedure.

Allergan is a healthcare company which develops and commercialises pharmaceuticals, biologics, medical devices and over-the-counter consumer products.

Allergan’s Botox has received a positive opinion from the Irish Medicines Board for the treatment of urinary incontinence in adults with neurogenic detrusor overactivity (NDO).

The decision is based on a global Phase III study that showed Botox injections into the bladder muscle reduced involuntary contractions and increased bladder capacity.

Douglas Ingram, President of Allergan in Europe, Africa and the Middle East, stated that the drug is “a significant step towards improving daily functioning and overall quality of life”.

Allergan plans to gain approval for the use of Botox in all 14 European Countries involved in the Mutual Recognition Procedure.

The drug is intended to treat urinary incontinence resulting from neurogenic bladder due to stable sub-cervical spinal cord injury (SCI) or multiple sclerosis (MS).

In Europe, approximately 656,000 people live with MS and, on average, nearly 11,000 people are diagnosed with SCI per year.

Between 60-80% of people with MS and 75-80% of people with SCI will suffer from bladder dysfunction.

Allergan is a healthcare company which develops and commercialises pharmaceuticals, biologics, medical devices and over-the-counter consumer products.