NOV 15, 2016
Ocular Therapeutix has reported positive topline results from their phase 3 trial of Dextenza, a dexamethasone insert for treating ocular inflammation and pain following cataract surgery.
Inserted through the punctum into the canaliculus, the bioresorbable plug delivers a 4-week tapered release of corticosteroid to the ocular surface.
The prospective, multicenter, double-masked trial met its primary endpoints of statistical superiority over the control treatment for absence of anterior chamber (AC) inflammatory cells on day 14, and absence of pain on day 8, following clear corneal cataract surgery. On day 8, 79.6% of Dextenza patients reported absence of pain, compared with 61.3% of patients who received a placebo punctum plug (P<0.0001). On day 14, 52.3% of Dextenza patients showed absence of inflammatory cells, compared with 31.1% in the control group (p<0.0001).
The secondary endpoints of differences between the Dextenza and control group for absence of AC cells and pain at days 2, 4, 14 and 30 were also met with significance, except for absence of AC cells at day 2. Other secondary endpoints and safety data are still being assessed.
Two previous phase 3 trials on Dextenza for treatment of ocular pain following cataract surgery were used in the company’s New Drug Application (NDA), submitted in 2015. In July 2016, they announced receipt of the FDA’s Complete Response Letter, which identified concerns over deficiencies in the manufacturing process observed during inspection. According to an August 2016 press release, all but 1 of the 10 issues raised have been resolved, and Ocular Therapeutix plans to resubmit the NDA shortly.
If the application is approved, the results from this recent trial will be submitted with an NDA supplement to expand Dextenza’s label to include an indication for post-surgical inflammation.