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Ocular Therapeutix™ Reports Second Quarter 2016 Financial Results and Provides Corporate Update

Conference call today at 8:30 am Eastern Time

BEDFORD, Mass.--(BUSINESS WIRE)-- Ocular Therapeutix, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the development and commercialization of innovative therapies for diseases and conditions of the eye, today announced financial results for the second quarter ended June 30, 2016.

“The second half of 2016 will be a busy time for Ocular Therapeutix (OCUL) as we prepare to initiate the first of two planned Phase 3 clinical trials with OTX-TP for the treatment of glaucoma and ocular hypertension during the third quarter,” said Amar Sawhney, Ph.D., President, Chief Executive Officer and Chairman. “Regarding our NDA for DEXTENZA for the treatment of post-surgical ocular pain, labeling discussions with the FDA are ongoing, and as we just announced, we are working to resolve the one remaining open manufacturing observation identified by the FDA in connection with their facility inspection. We will continue to work collaboratively with the FDA so they can finalize their review of our NDA, and we remain committed to bringing DEXTENZA to market.”

Recent Highlights and Anticipated Near-Term Milestones for Key Development Programs

DEXTENZA for the treatment of post-surgical ocular inflammation and pain

  • A New Drug Application (NDA) for DEXTENZA (dexamethasone insert) 0.4 mg, for intracanalicular use in the treatment of ocular pain occurring after ophthalmic surgery is pending with the U.S. Food and Drug Administration (FDA).
    • In July 2016, Ocular Therapeutix received a complete response letter (CRL) from the FDA that identified issues pertaining to deficiencies in the manufacturing process and controls, originally identified during a pre-NDA approval inspection of the Company’s manufacturing facility. The CRL for DEXTENZA did not identify efficacy or safety concerns with respect to the clinical data provided in the NDA nor any need for additional clinical trials for the approval of the NDA.
    • The FDA recently issued a letter noting that the corrective actions detailed in the Company’s responses as a whole appear to address the ten inspectional observations raised in the Form 483 with one exception which relates to the proposed process for identity testing of an incoming inert gas component used in the DEXTENZA manufacturing process. The FDA also requested that the Company provide evidence (e.g., a final report) when migration to automatic integration of analytical testing is complete, which is anticipated during the third quarter of 2016.
    • Should the FDA grant marketing approval for DEXTENZA for the treatment of ocular pain occurring after ophthalmic surgery by the end of 2016, the Company expects to apply for a pass-through reimbursement code used in the hospital and ambulatory surgery center setting and launch this product in the first half of 2017.
  • Ocular Therapeutix has completed enrollment in a third Phase 3 clinical trial for DEXTENZA for post-surgical ocular inflammation and pain.
    • The Company expects topline results from the trial to be available in the fourth quarter of 2016.
    • If the Company obtains favorable results from this third Phase 3 trial and subject to approval of the NDA for post-surgical ocular pain by the FDA, the Company intends to submit an NDA supplement for DEXTENZA aiming to broaden the label to include a post-surgical inflammation indication.

DEXTENZA for the treatment of allergic conjunctivitis

  • To date, the Company has conducted two Phase 3 clinical trials for DEXTENZA for the treatment of allergic conjunctivitis. The first trial met the primary endpoint for ocular itching. In June 2016, the Company reported that the second trial did not meet the single primary efficacy endpoint of ocular itching.
  • Following the second Phase 3 trial, a meeting was held with the FDA to discuss the results. Pending receipt of written feedback from the FDA, the Company will provide further guidance on the clinical development path forward for this indication at a later time.

DEXTENZA for the treatment of dry eye disease

  • Ocular Therapeutix has completed a Phase 2 clinical trial of DEXTENZA for the treatment of dry eye. In this trial, signs of total corneal staining decreased by a statistically significant level from baseline in the DEXTENZA group compared to placebo group.
  • A range of objective and subjective measures (signs and symptoms, respectively) and potential clinical trial designs are being evaluated for additional clinical development in dry eye-related indications.

OTX-TP (sustained release travoprost) for the treatment of glaucoma and ocular hypertension

  • Ocular Therapeutix plans to initiate the first of two planned Phase 3 clinical trials for OTX-TP (sustained release travoprost) for the treatment of glaucoma and ocular hypertension during the third quarter of 2016.
    • The primary efficacy endpoint will be the reduction of intraocular pressure (IOP) from baseline in the OTX-TP treatment...

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