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Palovarotene for the Potential Treatment of Dry Eye Disease

The treatment options available for dry eye disease do not treat the underlying disease process but there are symptomatic treatments, including artificial tears, lubricants, anti-inflammatory drugs (including topical steroids), topical cyclosporine (generic), Restasis® (cyclosporine emulsion), Lifitegrast®, tear retention devices (plug lacrimal puncta preventing tear drainage), topical antihistamines and mast cell stabilizers. Allergan’s Restasis® as well as Shire’s Lifitegrast® are currently the standard of care.

Planned Phase 1 and Phase 2 Trials

Scientific insights on the relative importance of RARγ receptors for mediating anti-fibrotic effects in the eye, our own in vivo studies with palovarotene, as well as the historical evidence supporting the clinical benefits of retinoids in dry eye disease, all provide a strong rationale for the development of a palovarotene eye drop formulation for the treatment of dry eye disease.

We intend to perform the local toxicology and pharmacokinetic studies necessary to initiate human studies. We are currently developing protocols for Phase 1 and Phase 2 studies. We intend to initiate a Phase 1 trial and a Phase 2 trial for palovarotene in dry eye disease in 2018.