Ocular launches lead product Dextenza in USA

1 July 2019

Ophthalmology specialist Ocular Therapeutix (Nasdaq: OCUL) has launched its lead product in the USA for the treatment of ocular inflammation and pain following ophthalmic surgery.

Dextenza (dexamethasone ophthalmic insert) is the first intracanalicular insert – a product with a novel route of administration that enables the delivery of drug to the surface of the eye – that has been approved in the USA. This avoids the need for a burdensome, monthly regimen of steroid eye drops.

The US Food and Drug Administration (FDA) originally granted approval to Dextenza, following issues with its submission, in November 2018 for the treatment of ocular pain following ophthalmic surgery, and then two weeks ago, the agency approved a supplemental New Drug Application (sNDA) to treat ocular inflammation following ophthalmic surgery, making it the only sustained release steroid product to be available in both indications.

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