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. Get the […]
oculartherapeutix
Ocular Therapeutix updates on Dextenza NDA, hopeful for resubmission
Ocular Therapeutix (NSDQ:OCUL) said today it received a complete response letter from the FDA covering the New Drug Application for Dextenza and updating that the company is hopeful it can resubmit the application “as soon as possible.” Ocular Therapeutix’s Dextenza, formerly known as OTX-DP, is designed to deliver sustained dosage of dexamethasone over 4 weeks using a hydrogel […]
FDA rejects Ocular Therapeutix’ Dextenza post-operative pain indication
Ocular Therapeutix (NSDQ:OCUL) said today it received a complete response letter from the FDA denying approval for its Dextenza for an indication for treating ocular pain occurring after ophthalmic surgery. 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 duct. The plug […]
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 […]
Ex-Insulet chief DeSisto out before he’s in at MannKind | Personnel Moves
MannKind Corporation said today it withdrew an offer that would have made ex-Insulet (NSDQ:PODD) CEO Duane DeSisto its new CEO only 19 days after officially posting its offer to DeSisto. The offer was withdrawn as objections were raised by DeSisto’s former employer Insulet, who said the new position would violate its non-competition agreement, which will be […]
Ocular Therapeutix touts Phase 2 topline data from Dextenza dry-eye trial
Ocular Therapeutix (NSDQ:OCUL) said today topline results from a Phase 2 clinical trial of its Dextenza drug-device combo used to treat inflammatory dry eye disease helped identify optimal patient populations for responders and future testing. Bedford, Mass.-based Ocular Therapeutix said the trial aimed to examine measures appropriate for future clinical trials to evaluate the Dextenza, or […]
Ocular Therapeutix Dextenza NDA accepted by FDA
Ocular Therapeutix (NSDQ:OCUL) said today the FDA accepted the new drug application for its drug-device combo Dextenza for treating ocular pain following ophthalmic surgery. 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 duct. The plug then dissolves […]
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 […]
AliveCor taps Google social SVP Gundotra for CEO | Personnel Moves
AliveCor said yesterday it tagged former Google (NSDQ:GOOG) social senior veep Vic Gundotra as its new CEO, replacing current interim CEO Euan Thomson. Gundotra served as senior veep at Google from 2011 to 2014, after joining as a veep in 2007. Gundotra was responsible for Google’s social networking and identity services, and is credited as […]
Haemonetics CEO Concannon steps down | Personnel Moves
Haemonetics (NYSE:HAE) said yesterday its CEO Brian Concannon resigned to pursue other opportunities and will be replaced by board member Ronald Gelbman, who will serve as interim CEO. The company said Concannon will remain with Haemonetics through the end of October to “ensure a seamless transition,” while the board searches for a permanent replacement. “Ron’s intimate […]
Ocular Therapeutix slides as Q2 beats rev, misses earnings
Ocular Therapeutix (NSDQ:OCUL) announced its 2nd quarter earnings on Monday, beating expectations on revenue but missing on earnings. Ocular Therapeutics reported losses of $9.6 million, or 45¢ per share, on sales of $459,000 for the 3 months ended June 30. That amounts to a 62% increase in losses on sales growth of 373% compared with […]
