Shares of Ocular Therapeutix Inc. (OCUL) have gained more than 14% over the last four trading days.
The Company is focused on developing drug products based on its proprietary hydrogel platform technology for the treatment of eye diseases.
The most advanced product candidate in Ocular's pipeline is Dextenza, a dexamethasone-releasing punctum plug, for treatment of ocular inflammation and pain following cataract surgery.
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Dextenza is administered as a one-time, bioabsorbable intracanalicular plug for release of sustained release dexamethasone, an ophthalmic corticosteroid, to the ocular surface.
The FDA refused to approve Dextenza last July, raising concerns pertaining to manufacturing process and controls.
After taking corrective actions, the Company resubmitted the New Drug Application for Dextenza in January of this year, which was accepted for review - with a decision date set for July 19, 2017.
A patient experience study of Dextenza, conducted with 25 patients, the results of which were announced yesterday, reveals that all patients were comfortable with the intracanalicular insert.
According to the study results, 96% felt the insert was extremely or very convenient compared to topical eye drops on a tapered schedule and 92% reported the highest level of overall product satisfaction, with 88% saying they would request the insert if they were to undergo cataract surgery again.
Dextenza is also being explored as a potential treatment for allergic conjunctivitis.
A phase III trial of Dextenza in allergic conjunctivitis, the results of which were reported in October 2015, achieved the primary endpoint of treatment of ocular itching associated with allergic conjunctivitis. The study did not meet the primary endpoint of conjunctival redness, an endpoint typically included in phase III trials for allergic conjunctivitis but not been required for approval.
Another phase III trial of Dextenza in allergic conjunctivitis, initiated in November 2015, did not achieve the primary endpoint of ocular itching associated with allergic conjunctivitis. The trial results were reported on June 6, 2016, and the stock got pounded that day - losing more than 40% of its value.
Ocular is planning to initiate a non-significant risk device study in the middle of 2017 to confirm the effect on efficacy of the placebo insert used in previous studies compared with a rapidly resorbing placebo insert. If all goes well, and the results are favorable, the Company plans to conduct an additional phase III clinical trial to further evaluate Dextenza for the treatment of allergic conjunctivitis.
Another product in the pipeline is OTX-TP for the treatment of glaucoma and ocular hypertension, which is under phase III testing.
The phase III program of OTX-TP is designed to have two trials, and enrollment is underway in the first of two planned trials.
The second phase III study of OTX-TP for the treatment of glaucoma and ocular hypertension is expected to commence in the second half of 2017.
If approved, OTX-TP may potentially become the first non-invasive, sustained release therapy for the treatment of glaucoma, says Ocular.
The Company has one marketed product - ReSure Sealant - for sealing clear corneal incisions following cataract surgery. Stitches were the only option for stopping fluid from leaking through the incision before ReSure was approved.
Made of two liquid solutions, a polyethylene glycol solution and a trilysine amine solution, ReSure forms the sealant gel when the two solutions are mixed together. ReSure was approved by FDA in January 2014, and its sales commenced in the first quarter of 2014.
Key Financial Data
-- Product sales of ReSure Sealant in 2016 rose to $1.9 million in 2016 from $1.4 million in 2015.
-- Net loss widened to $44.7 million or $1.80 per share in 2016 from $39.75 million or $1.71 per share in 2015.
-- The Company, which ended December 31, 2016 with cash of $68.1 million, completed a registered underwritten public offering of $25 million of shares of its common stock in January of this year.
Shares of Ocular have gained a modest 19% year-to-date, and trade around $9.90. With four months to go for the FDA decision, the stock price may experience a run-up into the catalyst.
by RTT Staff Writer
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