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Eyes itching from allergies? Ocular’s Dextenza wins FDA approval as first monthly implant

Patients with itchy eyes caused by allergic inflammation often take eye drops multiple times per day. Thanks to an FDA approval, a monthly insert into the canaliculus of the eye will soon be available.

Monday, the FDA approved Ocular Therapeutix’s Dextenza to treat eye itching associated with allergic conjunctivitis, making it the first physician-administered insert that treats the disease for up to 30 days with one administration. The med is a preservative-free, resorbable hydrogel that contains the popular corticosteroid dexamethasone as its active ingredient.

In this use, Dextenza could reach $250 million in peak sales if it can capture 5% to 6% market share of the single-agent prescription steroid eye drug market, Jefferies analyst David Steinberg wrote in a Monday note to clients.

With prior FDA nods in 2018 and 2019, Dextenza was already approved to treat ocular inflammation and pain following eye surgery. Monday’s approval marks the first indication for Dextenza’s use in the doctor’s office instead of on the operating table.

In the second quarter, the drug recorded sales of $11.1 million, a 65% jump from the first quarter. For the new use, Jefferies’ Steinberg is projecting a modest ramp initially, or $14 million in 2022 sales.

But Ocular will be tapping into a big market in this new use, with an estimated 10 million people in the U.S. annually seeing a doctor for inflammatory responses caused by allergies, the company says. A steroid like dexamethasone is commonly used for severe forms of allergic conjunctivitis, but compliance is poor as patients need to dose the drug at home up to four times a day, Steinberg noted. Misuse or overuse of drugs may cause damage to the eye, he added.

In contrast, Dextenza “puts treatment back in the hands of physicians for those patients,” and it offers “a meaningful compliance advantage” over existing therapies, Steinberg said.

Dextenza proved its mettle in three studies in patients with a history of ocular allergies. In all three studies, individuals on Dextenza reported lower average eye itching on a five-point score after an allergen challenge compared with the control group at all time points over the course of the experiments up to 30 days.

Outside of Dextenza, Ocular Therapeutix is applying its hydrogel implant technology to several other pipeline products. These include another dexamethasone insert called OTX-DED for episodic dry eye disease.

The company is also testing OTX-TKI, which includes Pfizer’s VEGF inhibitor Inlyta, for wet age-related macular degeneration. But Ocular ran into a setback earlier this year when Regeneron pulled the plug on a collaboration to develop a sustained-release version of blockbuster anti-VEGF drug Eylea.