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 […]
FDA accepts second application for Ocular Therapeutix’s drug-delivering implant
Ocular Therapeutix (NSDQ:OCUL) said today that the FDA has accepted a new supplemental New Drug Application for its Dextenza, an ocular insert designed to release dexamethasone to relieve pain following ophthalmic surgery. The Bedford, Mass.-based company’s device is designed to deliver drugs for up to 30 days following treatment in a physician’s office. Ocular Therapeutix is […]
Ocular Therapeutix posts mixed Q4 results
Shares in Ocular Therapeutix (NSDQ:OCUL) fell in premarket activity today after the company posted mixed fourth-quarter results. The Bedford, Mass.-based company posted a net loss of -$17.4 million, or -42¢ per share, on sales of $504,000 for the three months ended Dec. 31, for sales growth of 3.5% compared with the same period last year. Earnings […]
Ocular Therapeutix inks $38m debt financing deal
Ocular Therapeutix (NSDQ:OCUL) said today that it inked a deal with an investor to issue $37.5 million in 6% subordinated convertible notes due 2026. The offering is slated to close on March 1, according to the Bedford, Mass.-based company. Ocular expects to reel in roughly $37.1 million in net proceeds from the offering, which it plans […]
Ocular Therapeutix doses first wet-AMD patient in implant trial
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 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 […]
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