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Ocular (OCUL) Gets FDA Nod for Label Expansion of Dextenza

Zacks Equity Research

Ocular Therapeutix, Inc. OCUL announced that the FDA approved a supplemental New Drug Application (sNDA) for Dextenza.

The drug is now approved for the treatment of ocular inflammation following ophthalmic surgery as an additional indication.

We remind investors that the FDA approved the company’s new drug application (NDA) for Dextenza for intracanalicular use to treat ocular pain post ophthalmic surgery last December.

With this upside, Dextenza is now approved for the treatment of both ocular inflammation and pain after ophthalmic surgery.

The approval of the sNDA was supported by three phase III randomized, vehicle-controlled studies wherein patients received Dextenza or a vehicle immediately upon completion of cataract surgery. Results showed that treatment with Dextenza had a higher proportion of patients, who were pain free on post-operative Day 8 than the vehicle group.

Dextenza is also being evaluated for allergic conjunctivitis.

Shares of Ocular have rallied 11% year to date compared with the industry’s growth of 9.1%.

 

Ocular is also developing OTX-TP (intracanalicular travoprost insert) for the reduction of intraocular pressure (IOP) in patients with glaucoma and ocular hypertension.  However, in May 2019, Ocular announced that its phase III program on OTX-TP for lowering IOP in patients with primary open-angle glaucoma or ocular hypertension did not meet the primary endpoint.

Ocular’s pipeline also includes OTX-TIC, an intracameral travoprost implant for the reduction of IOP in patients with glaucoma and ocular hypertension when greater IOP reduction is needed, and OTX-TKI, an intravitreal injection by fine gauge needle of a hydrogel, anti-angiogenic formulation of a tyrosine kinase inhibitor (TKI), for the treatment of wet AMD (age-related macular degeneration).

Moreover, Ocular has a collaboration deal with Regeneron Pharmaceuticals, Inc., REGN for the development and potential commercialization of products containing its extended-delivery hydrogel in combination with Regeneron’s VEGF inhibitor, Eylea.

Additionally, Ocular markets ReSure Sealant, a hydrogel ophthalmic wound sealant, approved by the FDA to seal corneal incisions following cataract surgery.

However, competition is stiff in the ophthalmology market with the likes of Aerie Pharmaceuticals AERI in the fray.

Zacks Rank

Ocular currently carries a Zacks Rank #3 (Hold).  A better-ranked stock in the same space is Eisai Co. ESALY, carrying a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Eisai’s earnings per share estimates have inched up to $1.96 for 2019 in the past 90 days.

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