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 […]
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. The Bedford, Mass.-based company won […]
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 […]
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 […]
Ocular Therapeutix OTX-TP trial misses primary endpoint
A Phase 3 clinical trial of the ORX-TP eye insert made by Ocular Therapeutix (NSDQ:OCUL) failed to meet the primary endpoint of significant superiority in the reduction of intraocular pressure. OTX-TP is an intracanalicular insert that delivers a preservative-free formulation of travoprost to reduce intraocular pressure. The randomized, double-blind, placebo-controlled clinical trial took place across more […]
Ocular Therapeutix escapes SEC probe
The SEC recently closed its probe into Ocular Therapeutix (NSDQ:OCUL) and found no wrongdoing in the investigation. Ocular Therapeutix received a subpoena from the SEC on Dec. 15, 2017, for documents and information pertaining to its Dextenza 0.4mg and related communication with the FDA, investors and other parties. The company received a second subpoena on Aug. […]
Ocular Therapeutix posts wider-than-forecast Q1 losses
Ocular Therapeutix (NSDQ:OCUL) posted first-quarter results today that were wider than the consensus on Wall Street, missing the earnings consensus and beating on revenue. The Bedford, Mass.-based company reported losses of -$17.1 million, or -45¢ per share, on sales of $492,000 for the three months ended March 31, widening its losses by 24.4% on sales […]
Ocular Therapeutix settles Mati Therapeutics patent spat, logs CMS win for Dextenza
Ocular Therapeutix (NSDQ:OCUL) said this week it settled a patent spat with Mati Therapeutics and that it won reimbursement from the Centers for Medicare and Medicaid Services for its Dextenza ocular insert. In an SEC filing posted yesterday, the Bedford, Mass.-based company said that it settled its litigation with Mati Therapeutics and that both parties dismissed […]
Drug Delivery Business News
@DrugDeliveryNow
LinkedIn