Ocular Therapeutix, Inc. OCUL announced that it has submitted a supplemental new drug application (sNDA) for Dextenza (dexamethasone ophthalmic insert) to the FDA. The company is looking to expand Dextenza’s label for the treatment of patients with ocular inflammation following ophthalmic surgery. The FDA will complete its review in the second half of 2019.
Dextenza received the FDA approval for post-surgical ocular pain during the fourth quarter of 2018. With this nod, the drug became the first FDA-approved intracanalicular insert that delivers dexamethasone for treating ocular pain post ophthalmic surgery for up to 30 days with a single administration.
Shares of Ocular were up 2.5% in after-hours trading after the announcement of this news. Meanwhile, the stock has lost 18.6% in the past year, narrower than the industry’s decline of 31.5%.
The sNDA was based on positive data from two previous phase III studies and another multicenter, randomized, controlled phase III program, which evaluated the safety and efficacy of Dextenza.
We would like to remind investors that another product in Ocular’s portfolio is ReSure Sealant, a hydrogel sealant approved by the FDA to seal corneal incisions following cataract surgery. The drug is the first and the only surgical sealant to be approved by the FDA for ophthalmic use.
Another interesting candidate in Ocular’s portfolio is OTX-TP, which is being examined in phase III study for the treatment of glaucoma and ocular hypertension. Two other phase I candidates in Ocular’s portfolio are OTX-TIC and OTX-TKI, presently being investigated for reducing intraocular pressure in patients with glaucoma and ocular hypertension and to treat VEGF induced retinal leakage for an extended duration, respectively.
Zacks Rank & Stocks to Consider
Ocular currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the same sector include BioSpecifics Technologies Corp BSTC, Hikma Pharmaceuticals Plc HKMPF and Cumberland Pharmaceuticals Inc. CPIX, each sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here .
BioSpecifics’ earnings estimates have been revised 16.8% upward for 2019 over the past 60 days. The stock has soared 45.3% in the past year.
Hikma’s earnings estimates have moved 6.9% north for 2019 over the past 60 days. The stock has surged 41.7% in a year.
Cumberland’s loss per share estimates has been narrowed 48.9% for 2019 in the last 60 days.
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