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Biotech Stocks Facing FDA Decision In October 2021

Ocular Therapeutix
Ocular Therapeutix

The FDA decision on Dextenza in the additional indication as a treatment of ocular itching associated with allergic conjunctivitis is expected on October 18, 2021.

Dextenza, developed by Ocular Therapeutix Inc. (OCUL), is an intracanalicular insert designed to deliver the steroid dexamethasone to the ocular surface for up to 30 days without preservatives.

Eye drops containing antihistamines and steroids are widely used to treat itchy eyes.

If approved for the new proposed use, Dextenza could provide an office-based, physician administered, preservative-free method of steroid delivery that benefit patients with ocular itching associated with allergic conjunctivitis, according to the company.

Dextenza is already approved by the FDA for the treatment of ocular inflammation and pain following ophthalmic surgery.

The net product revenue of Dextenza for the second quarter of 2021 was $11.1 million, a nearly 700% increase over the second quarter 2020, and an approximately 65% sequential increase over the first quarter of 2021.

OCUL closed Wednesday’s trading at $10.14, down 3.34%.