Ocular Therapeutix presented new data from its most recent phase 3 study evaluating the safety and efficacy of Dextenza (dexamethasone insert) 0.4 mg for the treatment of ocular pain and inflammation following cataract surgery. The data were released at the American Society of Cataract and Refractive Surgery Annual Symposium (ASCRS) in Los Angeles.
The FDA has set a target action date under the Prescription Drug User Fee Act (PDUFA) of July 19, 2017 for a decision regarding the potential approval of Dextenza for the treatment of ocular pain following ophthalmic surgery.
Primary endpoints included absence of anterior chamber (AC) cells (a sign of inflammation) at Day 14 and absence of pain at Day 8. Topical NSAIDs were not permitted. Both endpoints were statistically superior to placebo, with more than 52% of patients receiving Dextenza having no AC cells at Day 14 compared to 31.1% of placebo subjects. Additionally, 79% of patients in the Dextenza group reported no pain at Day 8 compared to 61.3% of the placebo group. Statistical superiority of Dextenza was also noticed at Day 2 for the absence of ocular pain and Day 4 for the absence of AC cells. There were no treatment-related serious adverse events (SAEs) and Dextenza was well tolerated in all clinical trials. No patients experienced any adverse events resulting in study withdrawal.
A cross-sectional, qualitative survey, commissioned by Ocular Therapeutix, evaluating patient experience of Dextenza among 25 patients from U.S. phase 3 investigational clinical trials was also presented at the ASCRS meeting. In the survey, 92% of patients reported the highest level of overall satisfaction with the product, and would recommend Dextenza to family and friends. Further, 96% of patients reported the highest level of satisfaction with regard to convenience. Additionally, 84% of patients reported that they would be willing to pay more for Dextenza and would request Dextenza again.
“Dextenza’s safety and efficacy profile, combined with a positive patient experience, provide a strong foundation for offering an alternative to current postoperative steroid eye drops, which are associated with compliance issues,” Amar Sawhney, PhD, President, Chief Executive Officer and Chairman of Ocular Therapeutix, said in a company news release. “If approved, Dextenza may reduce the patient burden of administering topical eye drops following ophthalmic surgery by enabling physicians to control the entire course of steroid therapy with a single administration.”
The company also presented data on the importance of pain assessment following ophthalmic surgery; preservatives in topical ophthalmic medications used after ocular surgery; a literature review on medical adherence for glaucoma; and the evaluation of a Phase 3 clinical development program for OTX-TP, a sustained release travoprost intracanalicular insert for the treatment of glaucoma and ocular hypertension.
Phase 3 Study Design
This prospective, 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 cataract surgery. The study enrolled 438 patients who were undergoing clear corneal cataract surgery at 21 sites throughout the United States. Immediately following surgery, patients were randomized to insertion of either Dextenza or a placebo vehicle. Primary efficacy endpoints evaluated the differences between the Dextenza treatment group and the placebo group for the absence of anterior chamber cells at day 14 and absence of pain at day 8. Secondary efficacy endpoints included absence of anterior chamber cells, absence of ocular flare, and absence of ocular pain across relevant time points during the 30-day treatment period.