Allergan’s multidose Restasis nabs FDA approval, heads to battle with Shire’s Xiidra

It’s not exactly going to be smooth sailing for Allergan’s multidose bottle version of dry-eye med Restasis. As it finally gets the green light from the FDA, a new challenge named Xiidra lies ahead.

The Allergan blockbuster works to reverse low natural tear production, a symptom that might be found among those with chronic dry eye disease--and the newly approved version turns the same formulation of single-vial Restasis, launched in 2003, into a multidose bottle. It also uses a patented unidirectional valve and air filter technology in place of a preservative. The new Restasis bottle uses less plastic than a package of single-use vials and will be available for the same price. 

The product ran into a regulatory setback early this March, as the FDA handed the Dublin drugmaker a complete response letter, asking for additional CMC information.

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Restasis was pretty comfortable with its monopoly status until Shire decided to enter the game with its dry-eye candidate lifitegrast, which is currently marketed under the brand name Xiidra. Allergan has been counting on the new multidose Restasis to give it a boost against the newcomer. 

It was quite a regulatory journey for Xiidra, too. Last October, the FDA handed the Irish biopharma a complete response letter of its own, saying the company had to provide more clinical work to convince the agency of the drug’s quality. It was almost a year later when Shire finally got what it wished for--an FDA approval for Xiidra for the treatment of both the signs and symptoms of dry eye disease.

Shire has since touted Xiidra as a first-of-its-kind eye drop approved in the U.S., since Restasis is only intended for “tear production,” not dry eye disease, even though the previous is one of the possible symptoms of the latter.

And now, with its new marketing strategies in place accompanying the launch of Xiidra, Shire seems determined to grab a share from Allergan’s blockbuster, despite a later entrance. About two months ago, it allied with actress Jennifer Aniston in promoting its new eye health and disease education campaign called “eyelove,” and even though the campaign does not specifically promote the product, it’s still good publicity for Shire.

On the other hand, Allergan, as a well-established player in the field, has recruited actress Marisa Tomei as spokesperson for Restasis marketing and has been downplaying the threat posed by Shire.

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