BEDFORD, Mass. (TheStreet) -- A small drug-containing plug inserted into the tear duct reduced swelling and pain in the eye following cataract surgery, according to late-stage study results announced by Ocular Therapeutix OCUL on Tuesday.
Ocular intends to seek U.S. approval for the device, OTX-DP, in the second quarter if results from a second, phase III study are also positive. The company expects to have results from the second OTX-DP study later this month.
Current prescription eye drops used once or twice daily following cataract surgery are relatively inexpensive and typically eliminate pain and swelling in 80-90% of patients. A cross-trial comparison doesn't make a strong case for OTX-DP being any better than eye drops.
OTX-DP is a small plug containing the steroid medication dexamethasone. When inserted into the tear duct, the plug is designed to release the steroid over four weeks to reduce swelling and control pain in patients following eye surgery. Today, doctors prescribe daily eye drops sold by companies like Bausch & Lomb (owned by Valeant Pharmaceuticals (VRX)), Allergan (AGN) and Alcon (owned by Novartis (NVS)) to treat the complications resulting from eye surgery.
Ocular says OTX-DP is a more convenient treatment because the device is inserted once and gradually dissolves over time. Yet the company hasn't conducted clinical trials that would demonstrate that OTX-DP is any better than eye drops in reducing swelling and pain in the eye.
In a randomized phase III study, 247 patients had either the OTX-DP or a dummy implanted after undergoing cataract surgery. After 14 days, 34% of OTX-DP-treated patients showed an absence of inflammatory cells in the anterior chamber of the eye compared to 15% for patient treated with the dummy device. The difference was statistically significant
In addition, 76% of OTX-DP-treated patients reported the absence of pain on day 8 compared to 36% of patients in the control arm, Ocular reports.
However, pain relief measured at day 8 is not a pre-specified efficacy endpoint in the phase III study. The company was supposed to measure pain relief at days 2, 4, 14 and 30. None of these results were reported in Tuesday's press release.
Ocular has yet to respond to questions about the OTX-DP phase III study results. The company is also developing its implantable drug-containing plug for other eye diseases, including glaucoma and wet age-related macular degeneration.
Shares of Ocular recently fell 2% to $39.53. The company went public in July at $13 per share.