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UPDATE 2-FDA review says Aerie glaucoma drug effectively lowers eye pressure; shares jump
2017年10月11日 / 下午1点34分 / 9 天前

UPDATE 2-FDA review says Aerie glaucoma drug effectively lowers eye pressure; shares jump

(Adds share price, background)

By Toni Clarke

Oct 11 (Reuters) - Aerie Pharmaceuticals Inc’s experimental glaucoma treatment Rhopressa is effective in lowering eye pressure a preliminary review by the U.S. Food and Drug Administration, has concluded, sending Aerie’s shares up as much as 19 percent.

The review, posted on Wednesday on the FDA’s website, comes two days ahead of a meeting of outside experts who will advise the agency on whether the treatment should be approved.

Glaucoma, a condition caused by damage to the optic nerve, is the second-leading cause of blindness in the world. It is expected to affect more than 4 million Americans by 2030, up from 2.7 million today.

The FDA said it agreed with Aerie’s overall conclusion that Rhopressa, when given once a day, effectively lowers pressure inside the eye. Elevated eye pressure can cause glaucoma. However, the agency said the product was less effective when given twice a day in people with the highest pressure.

The disease is typically treated with a class of drugs known as prostaglandins that lower eye pressure. These include Pfizer Inc’s Xalatan, known generically as latanoprost, Novartis AG’s Travatan and Allergan Plc’s Lumigan. Rhopressa was tested against an older drug called timolol.

Rhopressa is the first in a new class of treatments. It also lowers eye pressure, but does so by targeting the trabecular network, the main drain through which fluid flows out of the eye. It is intended to reduce the risk of changes in eyelash length and pigmentation.

Aerie has a second product in development, Roclatan, which combines Rhopressa and latanoprost and could be even more effective than Rhopressa alone. The company plans to file for approval for Roclatan later this year or early next year.

Analysts on average expect the two products to generate annual sales of roughly $900 million by 2023, according to Thomson Reuters data. Aerie’s shares rose 13 percent to $62.60 in morning trading. Earlier they rose to a year high of $65.89.

The FDA is scheduled to make its decision by Feb. 28, 2018. (Reporting by Toni Clarke in Washington; Editing by Chizu Nomiyama and Frances Kerry)

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