Sustained-release dexamethasone depot effective in lowering fluorescein staining
A dropless option for steroid therapy showed encouraging results in a phase II safety and efficacy study in patients with inflammatory dry eye disease.
Reviewed by John D. Sheppard, MD
Norfolk, VA-OTX-DP, a sustained-release dexamethasone 0.4 mg intracanalicular depot (Dextenza, Ocular Therapeutix), showed promise when compared with placebo in an exploratory phase II study in subjects with signs and symptoms of inflammatory dry eye disease, said John D. Sheppard, MD.
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“We have a very exciting prospect for eventual approval based on the initial data of both safety and efficacy and the possibility of achieving improvement in both the signs and symptoms of dry eye,” said Dr. Sheppard, Virginia Eye Consultants, Norfolk.
“You now have a device that’s also a medication and vice versa, a well-established drug and a well-established device in combination,” he added. “By providing that appropriate synergy, we’re hoping that the medication concentration and the decay profile of that particular plug are ideally suited to dry eye.”
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Overall, the polyethylene glycol-based hydrogel drug product was safe and well tolerated. While the study was not powered for statistical significance, the results showed that total corneal fluorescein staining scores at day 30 were significantly lower (p = 0.08) for eyes treated with the OTX-DP (-3.14) than in the placebo vehicle group (-1.10) when compared to baseline.
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