Ocular Therapeutix (NSDQ:OCUL) shares fell today on third-quarter results that narrowly topped the consensus forecast despite a bottom-line dip. The Bedford, Mass.–based ophthalmic insert maker posted losses of -$18,778, or -45¢ per share, on sales of $829,000 for the three months ended Sept. 30, for a 25.1% bottom-line slide on sales growth of 66.5%. Adjusted to […]
Ocular Therapeutix doses first patients in pivotal allergic conjunctivitis trial of Dextenza
Ocular Therapeutix (NSDQ:OCUL) yesterday said it dosed the first patients in a Phase 3 clinical trial of its Dextenza drug-device combination. The U.S.-based Phase 3 clinical trial is a multi-center, 1:1 randomized, double-masked, placebo-controlled trial slated to enroll 80 patients. The study will evaluate Dextenza 0.4mg to treat allergic conjunctivitis and ocular itching versus a placebo […]
Ocular Therapeutix’s ophthalmic device gains Medicare coverage early
Ocular Therapeutix (NSDQ:OCUL) said today that the Centers for Medicare and Medicaid Services has assigned a specific and permanent reimbursement J-code for its Dextenza ophthalmic insert, which is approved for the treatment of ocular inflammation and pain following ophthalmic surgery. The code assigned to Dextenza through the Healthcare Common Procedure Coding System will become effective on […]
Ablative Solutions taps medtech vet Rumrill for CEO | Personnel Moves, July 16, 2019
Ablative Solutions tapped 30-year industry veteran Kate Rumrill, the former chief executive at NeoSync, to be its new president & CEO. Rumrill, whose resume includes stints at Covidien, Aspect Medical Systems and Eli Lilly, is slated to keep her seat on NeoSync’s board, San Jose, Calif.-based Ablative Solutions said. The company makes the Peregine renal […]
Cutera snags Vyaire Medical’s Mowry for CEO | Personnel Moves, July 9, 2019
Cutera (NSDQ:CUTR) said today that it snagged Vyaire Medical CEO David Mowry to be its new CEO, effective immediately. The aesthetic device maker in January fired president & CEO James Reinstein after the company missed expectations for its 2018 top line, naming COO Jason Richey as interim chief executive. Mowry led Tornier to a $3.3 billion […]
Ocular Therapeutix launches Dextenza eye insert
Ocular Therapeutix (NSDQ:OCUL) yesterday announced the commercial launch of its Dextenza ophthalmic insert in the U.S. Dextenza is an ocular insert that is designed to release 0.4 mg of dexamethasone to relieve pain after ophthalmic surgery. It can deliver drugs for up to 30 days after treatment in a physician’s office. Get the full story on […]
Ocular Therapeutix gains second indication for drug-delivery eye insert
Ocular Therapeutix (NSDQ:OCUL) said today that the FDA has approved a supplemental NDA for its dexamethasone ocular insert, Dextenza. The Bedford, Mass.-based company requested in January 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 days […]
Plaintiffs appeal Ocular Therapeutix win in shareholder lawsuit
Ocular Therapeutix (NSDQ:OCUL) is facing a revived class-action lawsuit lodged by investors after its share price took a hit after it revealed problems with its Dextenza device. The lawsuit, filed in the U.S. District Court for Massachusetts in November 2017, alleged that the Bedford, Mass.-based company misled shareholders about problems found by FDA inspections in 2017 that sent […]
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