Ocular Therapeutix (NSDQ:OCUL) said today that it dosed the first patient in a study of its OTX-TKI tyrosine kinase inhibitor implant. The Phase I trial is slated to assess the bioresorbable device’s safety, durability and tolerability in people with wet age-related macular degeneration. The company’s investigational product is a bioresorbable hydrogel fiber implant formulated with a […]
Ocular Therapeutix
Ocular Therapeutix seeks second indication for drug-delivery eye insert
Ocular Therapeutix (NSDQ:OCUL) said yesterday that it submitted a supplement NDA to the FDA for its dexamethasone ocular insert, Dextenza. The Bedford, Mass.-based company requested that the U.S. regulatory agency expand the current indication for Dextenza to include the treatment of ocular inflammation following eye surgery. Dextenza is designed to deliver drugs for up to 30 […]
Ocular Therapeutix lands $25m term loan
Ocular Therapeutix (NSDQ:OCUL) said today that it closed a refinancing of its existing debt by landing a $25 million term loan with MidCap Financial and Silicon Valley Bank. The 5-year term loan facility expanded the company’s prior $18 million credit facility to $25 million. The proceeds from the loan were used to repay the $12.3 million […]
Ocular Therapeutix wins FDA nod for drug-delivery eye insert
Ocular Therapeutix (NSDQ:OCUL) said today that the FDA approved its resubmitted application Dextenza, an ocular insert designed to release dexamethasone to relieve pain following ophthalmic surgery. The regulatory win for the Bedford, Mass.-based company comes after much back-and-forth with the FDA; the agency has twice rejected Ocular Therapeutix’s application for Dextenza. The company’s device is designed […]
Ocular Therapeutix shares fall after Q3 earnings miss
Shares in Ocular Therapeutix (NSDQ:OCUL) fell today after the company missed EPS estimates on Wall Street with its third-quarter financial results. The Bedford, Mass.-based company posted a net loss of -$15 million on sales of $498,000 for the 3 months ended Sept. 30. Sales for the quarter were down -5% compared with the same period last year. Earnings […]
FDA deals warning letter to Ocular over eye sealant
Ocular Therapeutix (NSDQ:OCUL) said today that it received a warning letter from the FDA over its ReSure hydrogel ocular wound sealant. The warning letter, dated Oct. 17, relates to Ocular’s compliance with data collection and reporting obligations in a post-approval device exposure registry study, according to the company. The registry study was a condition for approval […]
Ocular Therapeutix beats The Street with Q2 results
Shares in Ocular Therapeutix (NSDQ:OCUL) rose this week after the company topped expectations on Wall Street with its second-quarter financial results. The Bedford, Mass.-based company posted a net loss of -$13.8 million on sales of $648,000 for the three months ended June 30, representing sales growth of 48% compared with the same period last year. Earnings […]
FDA to review Ocular Therapeutix’s resubmitted NDA for Dextenza implant
Ocular Therapeutix (NSDQ:OCUL) said today that the FDA formally accepted its resubmitted new drug application for Dextenza, an ocular implant designed to administer pain-relief drugs following ophthalmic surgery. The FDA issued a complete response letter to the Bedford, Mass.-based company last year, rejecting Ocular’s Dextenza application for the second time. The U.S. regulatory agency is set […]
Ocular Therapeutix resubmits NDA for ocular pain relief implant
Ocular Therapeutix (NSDQ:OCUL) said today that it resubmitted a new drug application for its Dextenza ocular pain relief implant to the FDA. The Bedford, Mass.-based company noted that the resubmitted application aims to address manufacturing deficiencies highlighted by the FDA last year when the agency rejected Dextenza for the second time. Ocular Therapeutix’s Dextenza device is designed to […]
Facing legal woes and SEC probe, Ocular Therapeutix posts mixed Q4
Shares in Ocular Therapeutix (NSDQ:OCUL) rose this morning after the company beat expectations on Wall Street with its fourth quarter earnings, but missed analysts’ sales estimates. The company is facing a slew of class action suits from investors, as well as a probe by the Securities and Exchange Commission regarding its post-surgical pain relief implant, Dextenza. […]
