Ocular Therapeutix (NSDQ:OCUL) said it plans to submit an new drug application to the FDA to broaden the indication for its OTX-DP drug-device combination for use in treating post-surgical ocular pain, which it plans to call Dextenza.
Phase IIb clinical trials for the drug in the treatment of glaucoma and ocular hypertension are more than 80% enrolled and on track to report top-line efficacy data in the 4th quarter, the Bedford, Mass.-based company said.
Clinical trials to test the drug’s efficacy on post-surgical ocular pain are planned for early and mid-2015, Ocular said.
OCUL share prices plunged in April after OTX-DP failed to meet a key endpoint in the 2nd clinical trial of the eye drug in reducing pain and inflammation after cataract surgery.
The treatment is designed to deliver sustained dosage over 4 weeks of the drug dexamethasone, using a hydrogel plug inserted into a tear duct. The plug then dissolves and is flushed from the body as tears.
"We are pleased with the overall progress of our pipeline of sustained-release drug delivery products in clinical and preclinical development. We continue to advance our clinical programs for the treatment of post-surgical ocular inflammation and pain, allergic conjunctivitis, inflammatory dry eye disease and glaucoma, with several anticipated milestones in the near-term. Furthermore, last week we presented preclinical data on our sustained release hydrogel depot for the delivery of anti-vascular endothelial growth factors for the treatment of wet age-related macular degeneration at the recent annual ARVO meeting in Denver. This is a promising platform for a condition that is one of the leading causes of blindness," CEO Amar Sawhney said in a press release.
