Disappointing results for dexamethasone punctum plug

In contrast to an earlier phase 3 study, Ocular Therapeutix reported disappointing results from the latest trial evaluating its sustained release dexamethasone punctum plug for pain and inflammation after cataract surgery.

The implant, known as OTX-DP, met only one of two primary efficacy endpoints in the second of two phase 3 clinical trials. While it reduced pain in treated patients, it failed to significantly reduce inflammation. Last month, the first phase 3 study demonstrated efficacy for both endpoints.

OTX-DP is designed to deliver dexamethasone to the ocular surface for approximately 4 weeks. Following treatment, it resorbs and exits the nasolacrimal system without need for removal.

“Although the efficacy results for the absence of inflammatory cells in the OTX-DP treatment group met our expectations, the placebo group response was significantly higher than expected,” said Amar Sawhney, PhD, president and CEO of the company. “We have begun a thorough analysis of the data from the second phase 3 trial to fully understand the difference in efficacy between these two trials that had essentially the same trial design and similar patient populations. We have examined the aggregate result on a post-hoc basis of the absence and very minimal presence of inflammatory cells (defined as 0 and 0.5 on a scale of 0 to 4.0) and the difference between the treatment and placebo groups was found to be highly significant (66.3% in the treatment group and 42.5% in the placebo group, P = 0.0004).”

The company plans to meet with the FDA to discuss these results and expects the safety data will enhance the product’s safety profile for obtaining regulatory approval for other indications, including allergic conjunctivitis and inflammatory dry eye.