Bayer begins phase 3 trial testing aflibercept in infant blindness
Bayer has begun a late-stage trial of its blockbuster aflibercept eye drug to prevent blindness in premature infants.
The anti-vascular endothelial growth factor (VEGF) treatment is being developed for the new indication of retinopathy of prematurity (ROP).
ROP occurs in premature infants as result of incomplete or abnormal development of blood vessels serving the retina.
This can cause scarring and retinal detachment leading to visual impairment and irreversible blindness.
The phase 3, multi-centre, randomised trial is designed to assess efficacy, safety and tolerability of intravitreal aflibercept for the treatment of ROP.
Around 100 infants will be enrolled in 34 countries and will be randomised to receive intravitreal aflibercept or laser photocoagulation.
The World Health Organisation and the International Agency for the Prevention of Blindness has made childhood blindness, including ROP, a priority for their VISION 2020 joint global initiative.
Already marketed by Bayer and development partner Regeneron as Eylea, the drug has been on the market since 2011 when it was approved for wet age-related macular degeneration.
Since then it has been approved in other ophthalmology indications including diabetic retinopathy and diabetic macular oedema.
Last year the FDA also approved a 12-weekly dosing schedule, allowing patients fewer visits to the clinic than with the previous four or eight-week dosing schedules.
The drug works by blocking the growth of new blood vessels, which grow up being the retina to cause impaired vision in diseases such as wet AMD.
Under the joint development deal Regeneron maintains exclusive rights to Eylea in the US.
Bayer has licensed the exclusive marketing rights outside the US, where the companies share equally the profits from sales of Eylea, except for Japan where Regeneron receives a percentage of net sales.
In the US alone last year, sales were more than $4 billion, although there is competition from the likes of Novartis with its Lucentis (ranibizumab), and off-label use of Roche’s cancer drug Avastin (bevacizumab).
Dr Joerg Moeller, Bayer’s head of R&D, said: “Childhood visual impairment and blindness can have far-reaching consequences, affecting all aspects of a child’s development. We have initiated this phase 3 study to evaluate the potential of providing physicians with an additional treatment for premature infants with ROP.”
Roche and Novartis are also working on next generation eye drugs, and Regeneron is working with US biotech Ocular Therapeutix to develop an extended-delivery VEGF drug using its bioresorbable hydrogel technology.
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