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Ocular Therapeutix Touts Study Findings for Dextenza Following Cataract Surgery.

M2 PHARMA-March 16, 2017-Ocular Therapeutix Touts Study Findings for Dextenza Following Cataract Surgery

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- US-based biopharmaceutical company Ocular Therapeutix, Inc. (NASDAQ: OCUL) has announced positive results of a patient experience study of Dextenza (dexamethasone insert) 0.4 mg for intracanalicular use.

The study, published in Patient Preference and Adherence, evaluated the overall patient experience and perceived value of Dextenza following cataract surgery.

Dextenza is a hydrogel-based drug-eluting intracanalicular insert that incorporates the US Food and Drug Administration -approved corticosteroid, dexamethasone, as the active ingredient.

Inserted non-invasively through the punctum, Dextenza resides within the canaliculus and delivers dexamethasone to the ocular surface for approximately 30 days.

Following the completion of treatment, Dextenza resorbs and exits the nasolacrimal system without need for removal.

The goal associated with Dextenza is to reduce the patient burden of administration of topical eye drops following ophthalmic surgery by enabling the physician to control the entire course of steroid therapy with a single administration.

The extended release benefit of Dextenza replaces the need for patients to administer steroid eye drops in a complex, tapering, several-times-a-day regimen over the course of a month. In parallel, Dextenza aims to remove the issues commonly associated with non-compliance of post-operative medications following ophthalmic surgery.

A New Drug Application for Dextenza is currently under review by the FDA for the treatment of ocular pain occurring after ophthalmic surgery. The FDA has set a PDUFA target action date for July 19, 2017.

The patient experience retrospective study was conducted with 25 patients who had received active treatment in the company's Phase 3 clinical trials of Dextenza for the treatment of post-surgical ocular pain and inflammation.

According to the company, patients reported that the intracanalicular insert was comfortable.

Ninety-six percent felt the insert was extremely or very convenient compared to topical eye drops on a tapered schedule. Ninety-two percent reported the highest level of overall product satisfaction, with eighty-eight percent saying they would request the insert if they were to undergo cataract surgery again.

Ninety-two percent of patients surveyed said they would recommend Dextenza to friends or family members.

In the company's third and most recent Phase 3 clinical trial, Dextenza successfully met the two primary efficacy endpoints, absence of ocular pain on day 8 and absence of ocular inflammation on day 14, when compared to placebo.

Dextenza has exhibited a favorable safety profile and has been well tolerated in all clinical trials, regardless of indication.

Subject to the approval of the NDA for post-surgical ocular pain by the FDA, Ocular Therapeutix intends to submit an NDA supplement for Dextenza to broaden its label to include a post-surgical inflammation indication.

Dextenza (dexamethasone insert) 0.4mg for intracanalicular use is placed through the punctum, a natural opening in the eye lid, into the canaliculus and is designed to deliver dexamethasone to the ocular surface for up to 30 days.

Following treatment, Dextenza resorbs and exits the nasolacrimal system without need for removal. The company has completed three Phase 3 clinical trials with Dextenza for the treatment of post-surgical ocular inflammation and pain.

In January, Ocular Therapeutix resubmitted an NDA to the FDA for Dextenza for the treatment of ocular pain occurring after ophthalmic surgery. The FDA has set a PDUFA target action date for July 19, 2017.

Subject to the approval of the NDA for post-surgical ocular pain by the FDA, Ocular Therapeutix intends to submit an NDA supplement for Dextenza to broaden its label to include a post-surgical inflammation indication.

Dextenza is also in Phase 3 development for the treatment of ocular itching associated with allergic conjunctivitis.

Ocular pain and inflammation are common side effects following ophthalmic surgery. Physicians prescribe topical corticosteroids as part of the standard of post-operative care.

If left untreated, inflammation of the eye may result in further ocular complications, which in some cases may cause permanent loss of vision.

Ocular Therapeutix's lead product candidate, Dextenza (dexamethasone insert) 0.4mg for intracanalicular use has completed Phase 3 clinical development for the treatment of ocular pain and inflammation occurring after ophthalmic surgery.

The FDA has accepted the company's NDA resubmission for Dextenza for the treatment of ocular pain occurring after ophthalmic surgery and has established a target PDUFA date of July 19, 2017. Ocular Therapeutix is also pursuing additional indications for Dextenza.

OTX-TP (travoprost insert) is in Phase 3 clinical development for glaucoma and ocular hypertension. Ocular Therapeutix is also evaluating injectable drug delivery depots for back-of-the-eye diseases.

Ocular Therapeutix's first product, ReSure Sealant, is FDA-approved to seal corneal incisions following cataract surgery.

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Date:Mar 16, 2017
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