Novartis takes aim at Shire and Allergan with dry-eye drug

Novartis has taken an option to in-license a dry eye drug from US-based Lubris outside Europe.

Shire finally launched its Xiidra (lifitegrast) dry eye drug in the US last year after an initial rejection by the FDA, aiming to tap into a multi-billion dollar market where there are few approved prescription treatments.

Sun Pharma has also bought rights to a late-stage dry eye treatment, as pharma companies develop prescription drugs in a market where Allergan’s blockbuster Restasis (cyclosporine), was the main player before Xiidra came along.

Now Novartis’s eye division Alcon is trying to get in on the act with Lubris’ ECF843, a recombinant form of human lubricin.

According to Novartis, this is a new therapeutic approach and a potential first in class treatment.

A small phase 2 study showed the potential to provide instant relief of symptoms and improve signs of the disease.

ECF843 demonstrated the potential to provide immediate improvement of symptoms likely by increasing lubrication across various eye and tear surfaces together with an improvement in signs of dry eye within 28 days – without reporting treatment-related adverse events.

The decision makes sense for Novartis, which already has over-the-counter artificial tear products such as Systane to treat dry eye.

Deficiency in lubricin, a glycoprotein expressed in areas of high shear stress and friction including the tear film, is observed in dry eye patients.

Lubricin binds to and protects tissues of the ocular surface, the assumed mechanism of ECF843. ECF843 is thought to restore the tear film function, reduce friction and therefore relieve the signs and symptoms of dry eye.

Novartis did not reveal financial details of the transaction.

Although there are few approved treatments currently, if the drug makes it through development, Novartis could find itself competing in a more competitive market.

Private equity firm Auven Therapeutics in January sold its late-stage dry eye treatment Seciera (cyclosporine), an improved version of Allergan’s Restasis to India’s Sun Pharma, shortly after a phase 3 trial met its targets.

Sun Pharma paid $40 million upfront for Auven’s portfolio company, Ocular Technologies, which holds the rights to Seciera (cyclosporine) and will make further milestone payments.

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