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Ocular Therapeutix to detail more Phase 3 data

April 25, 2017

Ocular Therapeutix, Inc. (NASDAQ: OCUL) today announced new data to be presented from its most recent Phase 3 study evaluating the efficacy and safety of DEXTENZA™ (dexamethasone insert, 0.4mg) for intracanalicular use, for the treatment of ocular pain and inflammation following cataract surgery, at the upcoming American Society of Cataract and Refractive Surgery (ASCRS) Annual Meeting, being held May 5-9, in Los Angeles, Calif.

The U.S. Food and Drug Administration (FDA) has assigned a target action date under the Prescription Drug User Fee Act (PDUFA) of July 19, 2017 for the potential approval of DEXTENZA™ for the treatment of ocular pain following ophthalmic surgery.

“We believe that DEXTENZA, which utilizes Ocular’s proprietary hydrogel platform technology to provide sustained release of steroid therapy for up to 30 days, has the opportunity to offer an attractive alternative to the current post-operative standard of care for those recovering from ophthalmic surgery,” said Jonathan H. Talamo, M.D., Chief Medical Officer of Ocular Therapeutix. “The new data to be presented highlight the efficacy and safety profile of DEXTENZA for the treatment of ocular pain and inflammation following cataract surgery, and underscore the Company’s efforts to help address the needs of patients currently using steroid eye drops, which are associated with compliance issues.”

Additional presentations will be made regarding recent positive results of a patient experience study of DEXTENZA as well as the importance of the assessment of pain. The Company will also present information surrounding its ongoing Phase 3 clinical development program with OTX-TP (travoprost insert) for the treatment of glaucoma and ocular hypertension.

Poster Presentations:

  • Safety and Efficacy of an Extended Release Dexamethasone Insert for Treatment of Ocular Inflammation and Pain after Surgery: Phase 3 Study – May 7th from 2:16 PM – 2:21 PM at the L.A. Convention Center – Meeting Room Level, 409A
  • Evaluating the Patient Experience After Implantation of a 0.4 mg Sustained Release Dexamethasone Intracanalicular Insert – May 7th from 2:11 PM – 2:16 PM at the L.A. Convention Center – Meeting Room Level, 409AB
  • Preservatives in Topical Ophthalmic Medications Used After Ocular Surgery – May 7th from 1:56 PM – 2:01 PM at the L.A. Convention Center – Meeting Room Level, 409AB
  • Adherence to Medical Therapy for Glaucoma: Review of the Literature – May 7th from 8:43 AM – 8:48 AM at the L.A. Convention Center – Meeting Room Level, 410

E-poster Presentations:

  • The Importance of Pain Assessment Following Ophthalmic Surgery
  • A Phase 3 Clinical Development Program for OTX-TP, a Novel Sustained Release Travoprost Intracanalicular Depot, for the Treatment of Patients with Open Angle Glaucoma or Ocular Hypertension

About DEXTENZA™ (dexamethasone insert, 0.4mg) for Intracanalicular Use

DEXTENZA 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 a supplement to its NDA for DEXTENZA to broaden its label to include a post-surgical ocular inflammation indication. DEXTENZA is also in Phase 3 development for the treatment of ocular itching associated with allergic conjunctivitis.

About Ocular Pain and Inflammation Following Ophthalmic Surgery

Ocular pain and inflammation are common side effects following ophthalmic surgery. Physicians prescribe anti-inflammatory drugs, such as 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. According to US Census data, by the year 2020 it is estimated that the number of Americans diagnosed with cataracts is expected to rise to approximately 30 million, representing a 32% increase over current prevalence estimates.

According to Market Scope, approximately 3.9 million cataract cases and over 5.6 million ocular surgeries were performed in the United States in 2016.


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