Ocular Therapeutix (NSDQ:OCUL) said today that the FDA accepted the company’s resubmitted New Drug Application for its post-surgical ocular pain reliever, Dextenza. The hydrogel plug, inserted into a patient’s tear duct, is designed to deliver a sustained dose of dexamethasone over 4 weeks following opthalmic surgery. The Bedford, Mass.-based company has had trouble gaining regulatory approval […]
Ocular Therapeutix
Ocular Therapeutix looks to raise $25m in public offering
Ocular Therapeutix (NSDQ:OCUL) said today that it launched a $25 million underwritten public offering of its common stock. The Bedford, Mass.-based company did not provide any specific pricing details for the offering. Cantor Fitzgerald & Co. is the sole bookrunner for the offering, according to regulatory filings. Yesterday, the company said today that it resubmitted a […]
Ocular Therapeutix resubmits NDA for Dextenza
Ocular Therapeutix (NSDQ:OCUL) said today that it resubmitted a New Drug Application to the FDA for its post-surgical ocular pain reliever. The hydrogel plug, inserted into a patient’s tear duct, is designed to deliver a sustained dose of dexamethasone over 4 weeks following opthalmic surgery. The Bedford, Mass.-based company has had trouble gaining regulatory approval for the […]
Ocular Therapeutix touts data from phase III trial of Dextenza
Ocular Therapeutix (NSDQ:OCUL) touted interim data today from its phase III trial of Dextenza for the treatment of post-surgical ocular inflammation and pain. The bioresorbable intracanalicular hydrogel plug is designed to release drugs at the ocular surface for up to 30 days. The company announced last month that Dextenza met the trial’s 2 primary efficacy endpoints: […]
OCUL registers for $40m stock sale
Ocular Therapeutix (NSDQ:OCUL) is looking to raise $40 million through a public stock offering, according to a prospectus filed with the federal Securities & Exchange Commission this week. The Bedford, Mass.-based company said it inked a controlled equity offering sales agreement with Cantor Fitzgerald & Co., and agreed to pay Cantor Fitzgerald commissions of up to 3% […]
OCUL’s Dextenza meets endpoints in pivotal study
Ocular Therapeutix (NSDQ:OCUL) said today that its post-surgical ocular pain reliever, Dextenza, met both primary endpoints in a pivotal trial for the treatment of post-surgical ocular inflammation and pain. The product is a bioresorbable intracanalicular insert, designed for drug release to the ocular surface for up to 30 days. The randomized, double-masked study enrolled 438 patients who were […]
Ocular Therapeutix plans FDA re-submission for Dextenza by end of year, earnings
Shares in Ocular Therapeutix (NSDQ:OCUL) surged this morning after the biopharmaceutical company met expectations on Wall Street with its 3rd-quarter results and announced it will re-submit its new drug application to the FDA for Dextenza, its post-surgical ocular pain reliever, by the end of the year. In July, the FDA denied approval for Ocular’s hydrogel plug designed […]
Ocular Therapeutix inks $315 deal with Regeneron
Ocular Therapeutix (NSDQ:OCUL) said today that it landed a licensing deal with Regeneron (NSDQ:REGN) to develop a sustained-release version of Regeneron’s aflibercept (Eylea), a therapy for wet age-related macular degeneration. The deal will cost Regeneron $10 million up front, and in total could cost the Tarrytown, N.Y.-based biotech $315 million if regulatory and commercialization milestones are met. The terms […]
Ocular Therapeutix shares plummet as 2nd Phase III misses primary endpoint
Ocular Therapeutix (NSDQ:OCUL) today saw shares dive over 40% after reporting the 2nd phase 3 clinical trial of its Dextenza drug-device combination failed to meet its primary endpoint. Bedford, Mass.-based Ocular Therapeutix’s Dextenza, formerly known as OTX-DP, is designed to deliver sustained dosage of dexamethasone over 4 weeks using a hydrogel plug inserted into a tear […]
Ocular Therapeutix launches another pivotal for Dextenza eye drug-device combo
Ocular Therapeutix (NSDQ:OCUL) said today that it launched another pivotal trial for its Dextenza drug-device combination, its 2nd study of the treatment for an allergic conjunctivitis indication. Bedford, Mass.-based Ocular Therapeutix has had mixed results with Dextenza, formerly known as OTX-DP, which is designed to deliver sustained dosage of dexamethasone over 4 weeks, using a hydrogel plug […]
