- Ocular Therapeutix continued pumping out positive clinical results for its post-surgery eye inflammation drug Dextenza (dexamethasone insert), disclosing on Wednesday the treatment met another secondary endpoint from a late-stage trial.
- The newest data showed patients who took Dextenza were less likely to have anterior chamber flare than those who received placebos. The anterior chamber is the area between the cornea and the iris, while flare refers to light that distorts as it bounces off proteins in that space spawned by inflamed cells or blood vessels.
- One of Dextenza's draws is its ability to dispense medicine for up to a month. The drug's success is likely to bolster confidence in Ocular's ability to create sustained-release treatments, which is important given that it recently inked a deal worth up to $315 million granting Regeneron access to the company's capsule technology platform.
For a small biotech, Ocular put a sizeable investment in Dextenza.
It's a risky decision. On one hand, ophthalmics is a fledging field capturing the interest of big players like Allergan, Shire and Regeneron with its large patient populations and potential for huge profits. On the other, the number of failed treatments and lost returns continues to pile up.
Fortunately for Ocular, Dextenza has performed well in the clinic.
The company initiated the Phase 3 trial – the third of its kind for Dextenza – as a means of getting a label expansion for the drug. It plans to release a safety assessment and resubmit a New Drug Application with the Food and Drug Administration in the first quarter of 2017.
Data from the trial showed Dextenza met primary endpoints for treating post-surgical eye pain, and provided significantly better results across almost all of the secondary endpoints. The study enrolled 438 patients who received either the drug or a placebo and were analyzed at five points over a 30-day period.
At the 30th day, 81% of patients who took Dextenza had an absence of anterior chamber cells and 90% had an absence of anterior chamber flare versus 63% and 79.5%, respectively, in the placebo group.
"The positive results for the secondary endpoint of absence of ocular flare build upon the successful topline results from this trial which we announced last month," Ocular's Chief Medical Officer Jonathan Talamo said in a Jan. 4 statement. "[T]he fact that we are seeing a statistically significant decrease in the absence of flare across all time points further supports the efficacy profile of Dextenza."