Date: 2015-04-06
Type of information: Results
phase: 3a
Announcement: resullts
Company: Ocular Therapeutix (USA - MA)
Product: OTX-DP (sustained release dexamethasone)
Action
mechanism: glucocorticoid agonist. OTX-DP is a product candidate placed in the canaliculus and designed to deliver dexamethasone to the ocular surface for approximately four weeks. Following treatment, OTX-DP resorbs and exits the nasolacrimal system without need for removal.
Disease: ocular inflammation pain following cataract surgery
Therapeutic area: Ophtalmological diseases
Country: USA
Trial
details: Two prospective, multicenter, randomized, parallel-arm, double-masked, vehicle-controlled Phase 3 clinical trials, referred to as the Phase 3a and Phase 3b clinical trials, were completed with a total of 487 patients (247 patients in Phase 3a and 240 in Phase 3b) undergoing unilateral clear corneal cataract surgery. Patients were randomized 2:1 to receive either OTX-DP or a placebo vehicle control punctum plug without active drug. Both primary efficacy measures, differences in the proportion of patients in each treatment group with absence of cells in the anterior chamber of the study eye, as measured using slit lamp examination, at day 14 and absence of pain, as graded by a patient-reported score of zero on a scale from zero to ten, at day 8 were recorded at each study visit. Secondary efficacy measures were absence of flare in the anterior chamber of the study eye at each evaluation date and absence of inflammatory cells in the anterior chamber of the study eye and absence of pain in the study eye at each evaluation date other than the day used for the primary efficacy measure.
Latest
news: * On April 6, 2015, Ocular Therapeutix announced topline data from the Company’s second of two Phase 3 clinical trials evaluating the safety and efficacy of its lead product candidate, OTX-DP (Sustained Release Dexamethasone, 0.4mg), for the treatment of ocular inflammation and pain following cataract surgery and reported additional details from the first Phase 3 clinical trial. The two primary efficacy endpoints for the OTX-DP Phase 3 clinical trials were statistically significant differences between the treatment group and the placebo group for the absence of pain on day 8 and absence of inflammatory cells on day 14. Both endpoints need to be met for the trials to be considered successful. In the second Phase 3 clinical trial, OTX-DP met one of the study’s two primary efficacy endpoints. In this trial, 77.5% of patients receiving OTX-DP reported an absence of pain in the study eye on day 8 following insertion of the drug product, compared to 58.8% of those receiving placebo vehicle control punctum plug, a difference which was statistically significant (p=0.0025). 39.4% of OTX-DP-treated patients showed an absence of inflammatory cells in the anterior chamber of the study eye on day 14 following drug product insertion, compared to 31.3% of those receiving placebo vehicle control punctum plug , a difference which was not statistically significant (p=0.2182). Additionally, there were a total of 240 patients enrolled in the second clinical trial, with a 2:1 randomization of treated and control patients. In March 2015, Ocular Therapeutix reported results from the Company’s first Phase 3 clinical trial of OTX-DP, which enrolled 247 patients (see below). Topline safety results have been evaluated for the two Phase 3 clinical trials of OTX-DP. There were no ocular or treatment related serious adverse events in the OTX-DP treatment group in either of the two Phase 3 clinical trials. There were two serious adverse events in the OTX-DP treatment group in the first Phase 3 trial (1.2% incidence), compared with three serious adverse events in the placebo group (3.6% incidence). There were two serious adverse events in the OTX-DP treatment group in the second Phase 3 trial (1.3% incidence), compared with three serious adverse events in the placebo group (3.8% incidence). Overall there were fewer adverse events in the treated group than in the placebo group. The Company expects to be able to use the safety data from these Phase 3 trials to support its other OTX-DP clinical development programs including allergic conjunctivitis. * On March 10, 2015, Ocular Therapeutix announced positive topline data from the first of two Phase 3 clinical trials evaluating the safety and efficacy of its lead product candidate, OTX-DP (Sustained Release Dexamethasone), for the treatment of ocular inflammation and pain following cataract surgery. The Phase 3a study, which enrolled 247 patients, met both primary efficacy measures, achieving a statistically significant improvement in the reduction of inflammatory cells and pain. 33.7% of OTX-DP-treated patients showed an absence of inflammatory cells in the anterior chamber of the study eye on day 14 following drug product insertion, compared to 14.6% of those receiving placebo vehicle control punctum plug (p=0.0015). In addition, 76.1% of patients receiving OTX-DP reported absence of pain in the study eye on day 8 following insertion of the drug product, compared to 36.1% of those receiving placebo vehicle control punctum plug (p< 0.0001). Ocular is continuing to analyze the safety findings from the clinical trial. The company plans to submit an NDA to the FDA for OTX-DP for post-surgical ocular inflammation and pain in the second quarter of 2015.
The secondary efficacy endpoints for the first Phase 3 clinical trial have also been evaluated. Statistically significant differences were seen for the absence of pain at days 2, 4, 14 and 30 in the OTX-DP treatment group compared to the placebo group. Statistically significant differences were seen for the absence of inflammatory cells at day 30 in the OTX-DP treatment group compared to the placebo group, and there were no statistically significant differences seen in the secondary endpoint for absence of inflammatory cells at the other time points in the OTX-DP treatment group in the first Phase 3 trial. Statistically significant differences were seen for the absence of flare at day 8, day 14 and day 30 but not at day 2 or day 4. Data regarding secondary efficacy endpoints for the second Phase 3 trial are still being evaluated.
