First Phase III success for OTX DP (Sustained Release Dexamethasone) for treatment of ocular inflammation- Ocular Therapeutix

Ocular Therapeutix, Inc. announced positive topline data from the first of two Phase III 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 IIIa 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 analyse the safety findings from the clinical trial.

Comment: Ocular has developed a hydrogel formulation that is intended to provide prolonged dosing for eye therapies, replacing the drops that are typically in use. The company is developing the concept for allergic conjunctivitis, inflammatory dry eye and glaucoma.