Bayer eye drug succeeds in long-term study

pharmafile | February 21, 2012 | News story | Research and Development, Sales and Marketing Bayer, Lucentis, aflibercept, wet AMD 

Bayer’s eye drug aflibercept has succeeded in a long-term study in patients with a common eye condition. 

The Phase III trial studied patients with macular oedema due to central retinal vein occlusion (CRVO) for one year with Bayer’s aflibercept.

The GALILEO study showed that after treatment with the drug, patients with CRVO could see more letters in an eye chart than those on placebo. 

The results specifically showed that 60% of patients on aflibercept gained at least 15 letters of vision from baseline, compared to just 32% of patients receiving placebo injections. 

Patients receiving the drug also gained on average 16.9 letters of vision, compared to a mean gain of 3.8 letters for patients receiving the sham injections.

This confirms the results seen in the shorter 24-week COPERNICUS study from last year. 

Aflibercept is a VEGF trap-eye that works by inhibiting the binding and activation of VEGF receptors, and is being developed in conjunction with US biotech firm Regeneron. 

The firm was granted FDA approval for aflibercept (branded as Eylea) in November for wet age-related macular oedema (AMD). 

Regeneron has already submitted a supplemental biologics license application in the US for CRVO, and has been granted an FDA action date of 23 September.

Bayer, who holds the rights to the drug outside of the US, plans to file the drug with the EMA in the second half of 2012 for CRVO. 

It submitted the drug for a licence in wet AMD in Europe last year, and expects a decision within the coming months. 

Aflibercept is shaping up to rival Roche and Novartis’ eye drug Lucentis (ranibizumab) that is licensed for wet AMD, CRVO and diabetic macular oedema across a number of markets.

Lucentis made $1.4 billion in US sales last year and Eylea is forecast to reach around $1.1 billion in peak annual sales. 

Kemal Malik, head of global development at Bayer, said: “The results of GALILEO and COPERNICUS are encouraging for patients with central retinal vein occlusion as they show a durable improvement in visual acuity after one year of treatment with VEGF trap-eye.”

Ben Adams 

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