Ocular Therapeutix

The company is evaluating sustained-release injectable anti-VEGF drug depots along with use of its proprietary hydrogel platform technology for anterior segment disorders (specifically pain and inflammation). Ocular Therapeutix’s OTX drug-eluting punctal plug is a non-invasive procedure that will eliminate drops (and the potential non-compliance).

During the past year, the company completed two of three planned Phase III studies on Dextenza (formerly known as OTX-DP), a dexamethasone sustained-release intracanalicular depot, for the treatment of postoperative pain and inflammation. Dextenza met the pain endpoint, and Ocular Therapeutix has used those results to file its New Drug Application; the third Phase III study will be used to expand the indication to include inflammation. Approval is expected in 2016.

A Phase III study on allergy and conjunctivitis showed statistical improvement over placebo, at least a one-half unit improvement over all time points, and at least a 1 unit improvement over a majority of time points in ocular itching in a conjunctival allergen challenge model.

The concept behind the company’s OTX technology is to “elute drugs out at a much lower concentration, so they don’t have the peak doses-associated side effects,” President and CEO Amar Sawhney, PhD, said. Because the firm is evaluating only currently marketed compounds, the studies are designed to determine whether the doses used in the sustained-release delivery will have an appropriate level of effect and what that duration of effect is, rather than whether the drugs are efficacious or safe.

Two Phase II studies on OTX-DP (sustained-release travoprost) showed a clinical efficacy of 5+ units, and the company is working with FDA to design its Phase III study. Both Phase IIa and IIb study results showed no adverse events, and no hyperemia.

On the anti-VEGF front, the firm is exploring feasibility of its delivery mechanisms and has been “quite successful” showing stability of these sustained therapies. The company is working on a protein and delivery site; the protein will be partnered and Ocular Therapeutix is in late-stage discussions with several potential partners. In a VEGF-induced leakage model, a single injection designed to elute out over 6 months was able to reduce that leakage. This first-in-class depot is multifactorial, it inhibits VEGFR2 as well as PIGF and Tie-2, and has shown good tolerability.

Dextenza is now in an exploratory Phase II dry eye study with readout expected before year-end. In preclinical models, the company is exploring cyclosporine; animal models have shown promise.
Ocular Therapeutix’s first product, ReSure Sealant, is commercially available.

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