February 12, 2017: Biotechnology firm Ocular Therapeutix’s stock is surging higher on rising money flow after the company announced on January 23, 2017, that it had resubmitted an NDA for Dextenza. Ocular Therapeutix announced on January 23, 2017, that it has resubmitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for DEXTENZA™ (dexamethasone insert) 0.4 mg, for the treatment of ocular pain occurring after ophthalmic surgery. DEXTENZA is a product candidate administered by a physician as a bioresorbable intracanalicular insert and designed for drug release to the ocular surface for up to 30 days.
Ocular Therapeutix resubmitted the NDA in response to a complete response letter (CRL) the Company received from the FDA in July 2016, which identified items pertaining to deficiencies in manufacturing process and controls. The Company expects to receive an indication of the scope and timing of the FDA’s review of the Company’s NDA resubmission within approximately 30 days. The Company believes that the FDA review period of the NDA resubmission will be up to two months if a Class 1 (minor review) designation is received and up to six months if a Class 2 (major review) designation is received. Class 1 or 2 designation is dependent on whether an FDA re-inspection of the Ocular Therapeutix manufacturing facility will be a condition of NDA approval.
We had a situation where Ocular Therapeutix was derailed on their plans for bringing Dextenza to market. Now, the company appears to be working through the FDA issues and so the stock is under accumulation again at these lower levels.
February 9, 2017: Cantor Fitzgerald initiates coverage of Ocular Therapeutix with an Overweight rating and a price target of $35.
January 4, 2017: Ocular Therapeutix announced additional positive secondary endpoint results from its most recent successful phase 3 clinical trial of DEXTENZA (dexamethasone insert) 0.4 mg, for the treatment of post-surgical ocular inflammation and pain. DEXTENZA is a product candidate administered by a physician as a bioresorbable intracanalicular insert and designed to release drug to the ocular surface for up to 30 days.
The secondary endpoint, the absence of anterior chamber (AC) flare, an indicator of inflammation, was statistically superior to placebo at all measured time points. Approximately 46% of patients in the DEXTENZA treatment group were shown to have an absence of AC flare at day 4 after insertion, which Ocular believes provides further support of the early onset anti-inflammatory effect of DEXTENZA. Additional secondary efficacy endpoints included differences in the absence of AC cells and ocular pain on days 2, 4, 14, and 30 after insertion. As previously reported, all of these secondary endpoints were met with statistical significance with the exception of the endpoint for the absence of AC cells at day 2.
As also previously announced, DEXTENZA successfully met the trials two primary efficacy endpoints, absence of ocular pain on day 8 and absence of ocular inflammation on day 14 when compared to placebo. In this Phase 3 clinical trial, for which the complete safety assessment will be available in the first quarter of 2017, no treatment-related serious adverse events were observed. DEXTENZA has exhibited a favorable safety profile and has been well tolerated in all clinical trials, regardless of indication.
Ocular Therapeutix Stock Chart
Founded in 2006, Ocular Therapeutix is a biopharmaceutical company focused on the development and commercialization of innovative therapies for diseases and conditions of the eye. The foundation of Ocular Therapeutix’s pipeline is based on its proprietary, bioresorbable hydrogel technology that uses polyethylene glycol, or PEG, as a key component. The most advanced product candidate, currently in Phase 3 clinical development, is a drug-eluting intracanalicular depot containing the steroid dexamethasone for the treatment of ocular inflammation and pain following cataract surgery. Ocular also is evaluating a sustained released prostaglandin analog that can deliver treatment up to 90 days for the reduction of intraocular pressure for patients with glaucoma or ocular hypertension. All product candidates in the development pipeline are designed to replace weeks or months of dosing using existing pharmaceuticals and biologics with as little as a single dose administration. Earlier-stage product candidates are focused on the treatment of allergic and bacterial conjunctivitis and the company is also investigating intravitreal injections for wet age-related macular degeneration (AMD).