Genentech announced that the FDA accepted its Biologics License Application (BLA) for its Port Delivery System (PDS) with ranibizumab. The PDS is a permanent, refillable eye implant that’s the approximate size of a grain of rice. It offers continuous delivery of a customized formulation of ranibizumab over a period of months to reduce the treatment […]
Optical/Ophthalmic
Glaukos completes enrollment in Phase 3 trials for iDose TR drug-eluting implant
Glaukos (NYSE:GKOS) announced today that it completed enrollment for a Phase 3 clinical program for its iDose TR sustained-release travoprost implant. San Clemente, Calif.–based Glaukos’ iDose TR implant contains a novel formulation of travoprost, a prostaglandin analog used to reduce intraocular pressure (IOP) through a design that continuously releases therapeutic levels of the medication for […]
FDA accepts resubmitted NDA for Xipere from Clearside Biomedical, Bausch Health
Bausch Health (NYSE:BHC) and Clearside Biomedical (NSDQ:CLSD) announced today that the FDA accepted their resubmitted new drug application for Xipere. Clearside Biomedical designed the investigational Xipere triamcinolone acetonide suprachoroidal injectable suspension therapy with a proposed indication for treating macular edema associated with uveitis. Xipere works with Clearside’s proprietary SCS Microinjector to access the back of […]
Noveome Biotherapeutics inks licensing deal for SipNose drug delivery device
Noveome Biotherapeutics announced that it entered a commercial license agreement to use SipNose’s proprietary drug delivery device. Yokneam, Israel–based SipNose develops its intranasal Cribriform Targeted Device (CT6), which, under the agreement, was licensed to Noveome to deliver the Pittsburgh-based company’s ST266 biologic to the central nervous systems, according to a news release. CT6 allows aerosolized […]
Glaukos expands microshunt licensing agreement with Santen Pharmaceuticals
Glaukos (NYSE:GKOS) announced that it entered into a new development and commercialization license agreement with Santen Pharmaceutical. San Clemente, Calif.-based Glaukos’ agreement with Santen Pharmaceutical supersedes the previous collaboration and distribution agreements between the two parties over Santen’s Preserflo MicroShunt, according to a news release. Financial terms of the deal were not disclosed. Santen designed […]
Ocular Therapeutix misses The Street on bottom-line leap
Ocular Therapeutix (NSDQ:OCUL) reported first-quarter results that missed the consensus forecast on Wall Street. The Bedford, Mass.–based eye disease therapeutic developer yesterday posted profits of $3.12 million, or $0.04 per share, on sales of $7.34 million for the three months ended March 31, 2021, for a bottom-line leap of 114% on sales growth of 181% […]
Kala Pharmaceuticals rises before hours on mixed bag Q1
Kala Pharmaceuticals (NSDQ:KALA) announced shares ticked up before hours today on first-quarter results that were mixed compared to the consensus forecast. The Watertown, Mass.-based company posted losses of -$30.4 million, or -49¢ per share, on sales of $3.2 million for the three months ended March 31, 2021, for a -38.5% bottom-line slide despite revenues that […]
Gyroscope Therapeutics launches IPO roadshow
Gyroscope Therapeutics announced today that it launched the roadshow for its initial public offering of nearly 7 million shares. London-based Gyroscope’s U.S. offering includes up to 6.75 million American Depository Shares (ADSs) representing 6.75 million ordinary shares, according to a news release. Gyroscope expects pricing for the IPO to range between $20 and $22 per […]
Canada approves J&J Vision’s drug-eluting contact lens
Johnson & Johnson Vision announced today that it received Health Canada approval for its Acuvue Theravision drug-eluting contact lens. Jacksonville, Fla.-based J&J Vision’s Acuvue Theravision with Ketotifen is touted as the first and only vision-correcting contact lens that relieves allergic eye itch through drug delivery. The company received Japanese approval for the lens last month. […]
Glaukos inks licensing deal with Intratus for Eyelid drug delivery platform
Glaukos (NYSE:GKOS) announced today that it entered into a licensing agreement with Intratus over its Eyelid drug delivery platform. San Clemente, Calif.-based Glaukos was granted a global exclusive license to research, develop, manufacture and commercialize Intratus’ patented, non-invasive Eyelid drug delivery platform for treating presbyopia, according to a news release. Financial terms were not disclosed. […]
