Ocular Therapeutix, Inc. OCUL announced the initiation of patient enrolment in the third phase III study on Dextenza (sustained release dexamethasone) for the treatment of post-surgical ocular inflammation and pain.
The prospective, multicenter, randomized, parallel-arm, double-masked, vehicle-controlled study will evaluate Dextenza on patients undergoing clear corneal cataract surgery. Top-line efficacy data is expected in late 2016.
We remind investors that last month, a New Drug Application (NDA) for Dextenza was submitted to the FDA for the treatment of patients with ocular pain following ophthalmic surgery. Moreover, the company intends to submit a supplemental NDA (sNDA) after gaining the initial NDA approval. This sNDA will be submitted for the treatment of post-surgical inflammation, if the ongoing study results are positive.
Apart from the abovementioned study, Dextenza is being evaluated in a phase III study for the treatment of allergic conjunctivitis and in a phase II study for the treatment of inflammatory dry eye. Top-line data from both the studies are expected in the fourth quarter of 2015.
According to information provided by the company, in the U.S., approximately 5.3 million ocular surgeries were performed in 2014.
We note that InSite Vision Incorporated’s INSV BromSite is currently under FDA review for the treatment of inflammation and prevention of ocular pain in the post-cataract surgery setting. A response from the FDA is expected by Apr 10, 2016.
Meanwhile, drugs like Allergan plc’s AGN Acuvail and Novartis AG’s NVS Durezol are presently approved for the treatment of inflammation and pain associated with ocular surgery.
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