Ocular Therapeutix Inc OCUL announced topline results from its Phase 2 trial of OTX-DED (dexamethasone intracanalicular ophthalmic insert) for the short-term treatment of dry eye disease.
- The clinical trial achieved its pre-specified primary endpoint, demonstrating a statistically significant change of bulbar conjunctival hyperemia from baseline to day 15 compared to vehicle hydrogel.
- The differences were statistically significant compared with the vehicle hydrogel for both the OTX-DED 0.2 mg group and the OTX-DED 0.3 mg group.
- OTX-DED inserts (both formulations) were observed to have a favorable safety profile and were generally well tolerated.
- There were no ocular serious adverse events.
- The most common ocular adverse events for subjects treated with OTX-DED were epiphora (lacrimation increase) (8.1%) and elevated intraocular pressure (IOP) (3.6%).
- Read Next: Ocular Therapeutix Stock Gains As Court Invalidates Drug Delivery Patent From Mati.
- Price Action: OCUL shares are up 0.32% at $6.18 during the market session on the last check Monday.
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