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Ocular Therapeutix strategizes design for phase 3 trials of OTX-TP

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Ocular Therapeutix is planning to initiate the first of two phase 3 clinical trials of OTX-TP for the treatment of glaucoma and ocular hypertension in the third quarter based on feedback from a recent meeting with the FDA, the company announced in a press release.

The planned design for the phase 3 trials includes an OTX-TP (sustained release travoprost) treatment arm and a placebo-controlled comparator arm that would use a non-drug eluting hydrogel-based intracanalicular depot.

The company expects the FDA will require OTX-TP “to show a statistically superior and clinically meaningful reduction” in IOP over placebo as a primary efficacy endpoint, the release said.

“We believe that a direct comparison of OTX-TP with a placebo comparator reflects the simplest and most real world appropriate clinical study design for this product,” Amar Sawhney, PhD, CEO, president and chairman of Ocular Therapeutix, said in the release.