Ocular Therapeutix 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.
The 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 postoperative standard of care for those recovering from ophthalmic surgery,” Jonathan H. Talamo, MD, Chief Medical Officer of Ocular Therapeutix, said in a company news release. “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.
- 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
- 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