The Bedford, Mass.-based company’s hydrogel plug, inserted into a patient’s tear duct, is designed to deliver a sustained dose of dexamethasone over 4 weeks following ophthalmic surgery. After the treatment is complete, the plug resorbs and exits the nasolacrimal system without the need for a removal procedure.
The retrospective patient experience study enrolled 25 patients who received treatment in the company’s Phase III trial of Dextenza. According to the data, all of the patients reported that the insert was comfortable and 96% felt that it was extremely or very convenient compared to topical eye drops. Patients were very satisfied with the product, with 88% saying that they would request Dextenza if they were to have cataract surgery again.
“We are encouraged by the experiences these patients shared, which add another dimension to the clinical results achieved in the Phase III clinical trials,” chief medical officer Dr. Jonathan Talamo said in prepared remarks. “If approved, we believe that Dextenza, which incorporates the company’s proprietary hydrogel platform technology, will offer an attractive alternative to the current post-operative standard of care of steroid eye drops for those recovering from ophthalmic surgery.”
Last week, Ocular shares fell after the biopharmaceutical company missed earnings expectations, but beat sales estimates on Wall Street with its 4th quarter results.
The company posted losses of -$-12.8 million, or -52¢ per share, on sales of $0.5 million for the 3 months ended Dec. 31, for bottom-line loss of -20.5% on sales growth of 17% compared with the same period last year.
Adjusted to exclude 1-time items, earnings per share were -52¢, behind consensus on The Street, where analysts were looking for sales of $0.48 million.
In January, Ocular resubmitted a New Drug Application to the FDA for Dextenza.