A new eye drop to treat moderate to severe dry eye could hit the international market as early as next year.
The aqueous solution, named Seciera, has started its Food and Drug Administration (FDA) Phase 3 confirmatory trial, with approximately 700 patients enrolled.
The medication’s patent owner, Auven Therapeutics, said it hoped to file FDA marketing approval in early 2017.
The company told OT it also planned to a complete a European Medicines Agency trial next year, with approval anticipated in 2018.
The drops contain a patented formulation of cyclosporine in nanomicelles – spheres of molecules at the nanometre scale – that gives enhanced penetration into the eye.
Auven co-founder, Dr Peter Corr, said that the medication previously showed a large reduction in ocular surface inflammation compared to the placebo in the Phase 2B/3 trials.
He added: “We anticipate this trial will demonstrate conclusively Seciera’s ability to offer significant improvement in tear production and decrease in ocular surface inflammation … We look forward to announcing top-line results during the fourth quarter of 2016.”Auven has great hopes for the eye drops, with a commercial assessment estimating ophthalmologist prescription rates meant sales could top $1bn a year. In the UK, cyclosporine eye drop formulations are available through hospital eye departments, but not currently through optometrists qualified to independently prescribe.
Image credit: National Eye Institute