Eye research closes in on blockbuster drugs

Most blockbuster medicines, that is to say drugs with sales of $1bn and more a year, fall into three categories: anti-inflammatory wonder drugs that treat everything from arthritis to psoriasis, cancer therapies and treatments for diabetes. A fourth is becoming increasingly important to “big pharma” — ophthalmology or, more simply, eyecare.

Few illnesses correlate more closely with an ageing population than eye diseases. By 2022, the world’s fifth best-selling drug with $7.7bn in annual revenues is expected to be Eylea, made by Regeneron, the large New York biotech group, says a recent report from research group Evaluatepharma. Eylea is used to treat one of the most common eye conditions, known as wet AMD that, with age, causes a breakdown of the macula, a small area of light-sensitive tissue at the back of the retina.

Left untreated, wet AMD can lead to a permanent loss of central vision. It affects about 4 per cent of white adults over 75, rising to 14 per cent for those of 80 and over. It is less common in black, Hispanic and Asian people.

The number of patients with AMD is set to rise steeply over the next few decades as people live longer, says the US National Eye Institute. It forecasts that by 2050, the number of Americans with the condition will have risen from about 2m in 2010 to almost 5.5m.

As with many new drugs, Eylea is administered by injection. Regeneron has been able to steal market share with the product because it needs to be injected only every eight weeks. This compares with four for Lucentis, which is sold in a partnership between Swiss pharma groups Novartis and Roche.

Allergan, one of the biggest players in eyecare, is developing Abicipar, now in the final stages of clinical testing and with blockbuster sales potential, analysts say. It might be administered as infrequently as every three months. “If you’re going to be poked in the eye, it’s quite an advantage,” says David Nicholson, Allergan’s head of R&D.

When late-stage trials of Abicipar began in 2014, Allergan looked to the global AMD market being about $10bn by 2019. That was predicated on high prices: Eylea costs about $1,800 per injection and Lucentis $2,000. It is unclear whether cash-strapped healthcare systems will pay for such costly drugs, especially when other, less expensive alternatives are at hand. Avastin, a cancer chemotherapy made by Roche, can be used to treat wet AMD. Since it is priced to be used in large tumour-killing quantities — and only tiny amounts need to be injected into the eye — it costs just $50 per average treatment every four weeks, says the American Academy of Ophthalmology.

Diseases of the eye correlate closely with an ageing population

The UK is debating whether doctors should routinely use Avastin “off label”, that is to say deploying the drug to treat wet AMD even though it has never been tested or approved for the condition. The UK’s Royal College of Ophthalmologists says switching from Lucentis or Eylea to off-label Avastin would save the National Health Service £100m a year.

Allergan is best-known for its wrinkle smoothing treatment Botox but its next top seller is Restasis for dry eyes. Restasis generated $1bn in sales last year.

It too faces competition from Shire, the Anglo-Irish drugmaker which in July won regulatory approval for Xiidra. Unlike Restasis, Xiidra is intended not just for patients who are suffering symptoms of dry eye, such as difficulty producing tears, but also for those with signs of the condition — meaning they do not realise they have it but are diagnosed after being examined by a doctor.

Shire reckons some 16m Americans display either symptoms or signs of dry eye and analysts expect Xiidra to become a blockbuster, in part by stealing share from Allergan. Andrew Baum, an analyst at Citi, forecasts peak annual sales of $2.5bn by 2030.

The biggest threat to established ophthalmology companies may come from smaller companies. New York biotech group Ophthotech is developing the drug Fovista for AMD, which has been shown to provide a significant improvement in vision when added to Lucentis. Analysts at investment bank Leerink say the drug has huge potential to become a “foundation therapy” for AMD sufferers. Recognising the threat, Novartis and Roche have jointly secured rights to sales outside the US in a deal worth up to $1bn.

New companies such as Spark Therapeutics are investigating gene therapies to stave off blindness. Such smaller groups could win a big slice of the eyecare market, which is set to grow by 10 per cent a year from $13.7bn today to $26bn by 2022, says GBI Research.