Boston, MA 10/09/2014 (wallstreetpr) – Ocular Therapeutix Inc (NASDAQ:OCUL) said that it has completed the process of enrollment for its two Stage three clinical studies on investigating Sustained Release Dexamethasone or OTOX-DP. The company indicated that the study was meant to treat ocular pain and inflammation after a surgery of cataract.
One-Time Administration
The company stated that OTX-DP should be administrated one-time, and the drug candidate was placed in the canaliculus, its statement revealed. It was designed to provide dexamethasone to the surface ocular for about four weeks. After the treatment, OTX-DP resorbs and leaves the system of nasolacrimal without any need for its removal.
Ocular Therapeutix Inc (NASDAQ:OCUL) said that it was evaluating 486 patients in 32 sites around the United States through the two prospective, randomized, multicenter, double-masked, parallel-arm and vehicle-controlled trials. After the surgery, patients were randomized to get any one of placebo vehicle punctum plug or OTX-DP without any active drug. The company pointed out that the primary efficacy endpoints indicated a reduction in pain on day eight and inflammatory cells in eye’s anterior chamber on day 14.
FDA Submission Next Year
The company said that it was looking forward to presenting the results to the Food and Drug Administration next year.
Ocular Therapeutix Inc (NASDAQ:OCUL) said that generally for treating ocular pain and inflation after an ophthalmic surgery, topical corticosteroids were prescribed. However, it presented a complex regimen that had the potential to lead to lower compliance levels, which would ultimately lead to an adverse outcome.
On the other hand, administering topical corticosteroids could lead to higher intraocular pressure that might stimulate glaucoma. The company said that physicians hold the compliance wherever a physician administers a single-dose corticosteroid. This might also enhances the issue of patient non-compliance as far as dosing regimens were concerned.
Management Speaks
The Ocular Therapeutix Inc (NASDAQ:OCUL)’s President and CEO, Amar Sawhney, said that the completion of enrollment was an extraordinary milestone for the company. He pointed out that it was the first Phase 3 studies ever to be completed for a sustained release.
