US-based biopharmaceutical firm Ocular Therapeutix has started patient enrolment in a third Phase III clinical trial of Dextenza (sustained release dexamethasone) 0.4mg Intracanalicular Depot, to treat post-surgical ocular inflammation and pain.
Recently, the company submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) seeking approval for Dextenza for this indication.
The NDA was filed based on the results of the company’s two previously completed Phase III trials and follows a Pre-NDA clinical meeting with the FDA in April 2015.
The company currently aims to submit a supplement to the NDA to treat post-surgical inflammation as part of its label expansion strategy for Dextenza if it obtains favourable results from this third Phase III trial and subject to receiving approval of the pain indication according to the initial NDA.
Ocular Therapeutix president, chief executive officer and chairman Amar Sawhney said: "This is an important step for Ocular as we continue to execute on our label expansion strategy for Dextenza and we look forward to offering patients this innovative alternative to steroid eye drop therapy."
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A total of 436 patients undergoing clear corneal cataract surgery at 20 sites throughout the US are being enrolled in this prospective, multicenter, randomized, parallel-arm, double-masked, vehicle-controlled Phase III trial.
In the trial, patients will be randomised to either Dextenza or a placebo vehicle after their surgery.
Primary endpoints in the trial are absence of anterior chamber cells at day 14 and reduction of pain at day eight.
Based on data from the two previously conducted trials and following a Pre-NDA clinical meeting, the company has modified the trial design such as 1:1 patient randomisation of treatment and placebo groups instead of a 2:1 randomisation.
The major modifications carried out in the trial include exclusion of patients who are being treated with high dosage levels of oral nonsteroidal anti-inflammatory drugs, or NSAIDs; and improvement of the training and guidance to the on-site clinical investigators regarding adherence to study protocols, including the appropriate use of rescue medications.
Top-line efficacy results from this trial are expected to be available in late-2016.
