Bedford, Mass.-based Ocular Therapeutix’s Dextenza, formerly known as OTX-DP, is designed to deliver sustained dosage of dexamethasone over 4 weeks using a hydrogel plug inserted into a tear duct. The plug then dissolves and is flushed from the body as tears.
The primary endpoint for the company’s 2nd Phase III trial of the device, which was exploring the efficacy of the device at treating ocular itching for patients with allergic conjunctivitis, was a significant reduction in ocular itching at 7, 14 and 21 days, the company said.
Results from the study indicated a lower, but not statistically significant difference between the placebo group and those implanted with Dextenza, Ocular Therapeutix reported.
Shares in Ocular Therapeutix have dropped 42.2% so far, at $6.85 as of 9:37 a.m. EDT.
“We are disappointed that the primary endpoint of ocular itching associated with allergic conjunctivitis was not achieved in our second Phase 3 trial in these patients, and this result is inconsistent with what we saw in our 1st Phase 3 trial. We are currently in the process of conducting a thorough analysis of the data from the second Phase 3 trial to fully understand the difference in efficacy between the 2 Phase 3 trials. There was a greater variability in ocular itching exhibited by patients in the second Phase 3 trial over the multiple allergen challenges 7, 14 and 28 days following insertion of the depots, compared to the first Phase 3 trial. In a post hoc analysis, when ocular itching scores were averaged over these multiple visits, a statistically significant reduction of symptoms over the entire 1 month intended duration of sustained release, single dose therapy was observed in the Dextenza treatment group relative to the placebo vehicle group. Since this analysis was not part of the original end points, we plan to meet with the FDA to discuss the results and chart an appropriate path forward for the development of Dextenza for the treatment of allergic conjunctivitis,” CEO Amar Sawhney said in a press release.
The company reinforced that past trials have reported positive results when using the device to treat ocular itching, and said it is examining data from the study. Ocular Therapeutix reported no adverse events during the trial.
This isn’t the 1st miss for Ocular Therapeutix, which failed to meet a key endpoint during the 2nd clinical trial exploring the efficacy of the device for treating pain & inflammation following cataract surgery.
The 240-patient trial met its pain endpoint but missed the inflammation endpoint. Although 77.5% of patients in the Dextenza arm reported no pain after 8 days, compared with 58.8% of the control arm, the difference in inflammatory cell counts after 14 days was not statistically significant (39.4% vs. 31.3%), the company said, noting that both endpoints had to be met to consider the study a success.
Ocular Therapeutix is slated meet with the FDA in July as the company seeks FDA clearance for the device for those same indications.
“We remain confident in the potential of our innovative sustained release platform to address diverse applications in ophthalmology. We look forward to the July 2016 PDUFA date for Dextenza for the treatment of post-surgical ocular pain,” Sawhney said in a press release.