Shares of Ocular Therapeutix, Inc. OCUL were up 3% following the company’s announcement of positive results from its third phase III trial on lead pipeline candidate Dextenza 0.4 mg for the treatment of post-surgical ocular inflammation and pain.
Notably, Ocular has outperformed the Zacks classified Medical Drugs industry in the last twelve months. In fact, the stock has improved 1.5% during this period, compared with a decline of 20.2% for the industry.
The multicenter, 1:1 randomized, parallel-arm, double-masked, vehicle-controlled study was designed to evaluate the safety and efficacy of Dextenza for the treatment of ocular inflammation and pain following the ophthalmic surgery.
Dextenza incorporates corticosteroid dexamethasone as an active pharmaceutical ingredient into a hydrogel-based drug-eluting intracanalicular depot.
The results show that 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 arm showed an absence of AC flare at day four after insertion. The trial met all other secondary endpoints with statistical significance with the exception of the endpoint for the absence of AC cells at day two.
Notably, Dextenza had earlier met the trial’s two primary efficacy endpoints, absence of ocular pain on day eight and absence of ocular inflammation on day 14 when compared to placebo.
The complete safety assessment data will be out by the first quarter of 2017. We note that this is the third phase III trial. Ocular plans to resubmit a New Drug Application (NDA) to the FDA for Dextenza for the treatment of ocular pain occurring after ophthalmic surgery early in the first quarter of 2017 based on the results from the first two phase III trials.
We remind investors that the company submitted a NDA to the FDA in Sep 2015. In Jul 2016, the company received a Complete Response Letter (CRL) from the FDA whereby the FDA raised concerns related to deficiencies in manufacturing process and controls identified during a pre-NDA approval inspection of our manufacturing facility in February 2016 that were documented on FDA Form 483.
Ocular is conducting the third phase III trial to support a label expansion strategy for Dextenza assuming a potential approval for post-surgical ocular pain by the FDA. The company plans to submit a supplemental NDA for Dextenza to broaden its label to include an indication for post-surgical inflammation upon approval for post-surgical ocular pain.
We note that the company is also evaluating Dextenza for allergic conjunctivitis. Private-held Icon Biosciences, Inc. is evaluating its late stage candidate, IBI-10090 for the treatment of inflammation associated with cataract surgery.
The other candidate in Ocular’s pipeline is OTX-TP which is being evaluated for the treatment of glaucoma and ocular hypertension. Competition is gearing up in the glaucoma market as well as with companies like Aerie Pharmaceuticals, Inc., AERI developing a Rho kinase/norepinephrine transport inhibitor. Aerie's two lead product candidates – Rhopressa and Roclatan – are once-daily lowering intraocular pressure (IOP)-lowering therapies with novel mechanisms of action (MOAs) to treat patients with glaucoma or ocular hypertension. On the other hand, Inotek Pharmaceuticals Corporation ITEK recently announced that its lead candidate trabodenoson failed to meet its primary endpoint for the treatment of primary open-angle glaucoma or ocular hypertension.
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Cambrex’s earnings estimates increased from $2.46 to $2.55 for 2016 and from $2.91 to $3.06 for 2017 over the last 90 days. The company posted a positive earnings surprise in three of the four trailing quarters with an average beat of 19.78%. Its share price has increased 26.7% in the last twelve months.
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