Allergan has more to smile about with tear stimulating device
Allergan is to set to file a new medical device which treats dry eye disease by stimulating the production of tears.
The company already a major ophthalmology business, and will add to this with its new Oculeve Intranasal Tear Neurostimulator.
The handheld device is inserted into the nose and helps restore tear production in people with chronic dry eye disease, a condition suffered by an estimated 25 million people worldwide.
The company has announced that two pivotal trials of the device each met their primary and secondary efficacy endpoints, and says the results mean a premarket submission for the device is on-track for Food and Drug Administration (FDA) filing in the second half of 2016.
Allergan’s dry eye treatment Restasis (cyclosporine ophthalmic emulsion) is its second biggest selling drug (after Botox), earning $1.04 billion in 2015, and the new device will complement its top-seller.
The company is expecting US approval of a multi-dose preservative free formulation of Restasis in the second half of 2016.
Other major developments in its eye care division is the filing of XEN45, an ocular stent to treat glaucoma, expected in the second half of 2016.
Finally, phase 3 trial enrolment for Bimatoprost SR, a drug eluting implant for glaucoma, is expected to be completed by early 2017.
The good news from its eye care division is part of a major bounce Allergan has enjoyed in recent weeks – despite the planned merger with Pfizer being called off in April.
Allergan has just reported better-than-expected Q1 profits 16 profits, and the announcement that it would buy back up to $10bn in company stock lifted its share price by 10% last week.
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