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Optical/Ophthalmic

NovaBay Pharmaceuticals to distribute Okra Limited’s dry eye products

August 19, 2021 By Sean Whooley

NovaBay Pharmaceuticals

NovaBay Pharmaceuticals (NYSE:NBY) announced today that it agreed with Okra Limited to distribute its Zocular dry eye products. The agreement allows NovaBay to distribute Zocular dry eye products alongside Avenova in its physician-dispensed sales channel. Zocular products are formulated with patented Zokrex technology, which contains activated natural okra polysaccharide complexes designed to gently and effectively […]

Filed Under: Business/Financial News, Drug-Device Combinations, Featured, Optical/Ophthalmic Tagged With: novabay

Ocular Therapeutix misses on earnings, tops Q2 revenue estimates

August 10, 2021 By Sean Whooley

Ocular Therapeutix logo

Ocular Therapeutix (NSDQ:OCUL) shares ticked up this morning on second-quarter results that topped revenue forecasts. OCUL shares were up nearly 2% at $10.94 apiece in morning trading today. MassDevice‘s MedTech 100 Index, which includes stocks of the world’s largest medical device companies, was down slightly. The Bedford, Mass.-based ophthalmology drug delivery company posted losses of […]

Filed Under: Business/Financial News, Drug-Device Combinations, Featured, MassDevice Earnings Roundup, Optical/Ophthalmic, Pharmaceuticals Tagged With: Ocular Therapeutix

Eyevensys raises $12M for its gene therapy ocular drug delivery platform

August 4, 2021 By Sean Whooley

Eyevensys

Eyevensys, a developer of gene therapies for ophthalmic diseases, announced today that it raised $12 million in a Series B plus funding round. The funding, led by Korea Investment Partners, also includes existing investors who will join the round and support the accelerated development of Eyevensys’ EYS809 program for treating wet age-related macular degeneration (AMD) […]

Filed Under: Business/Financial News, Drug-Device Combinations, Featured, Funding Roundup, Optical/Ophthalmic Tagged With: Eyevensys

FDA grants iStar Medical IDE for glaucoma implant pivotal trial

July 15, 2021 By Sean Whooley

MINIject iSTAR

iSTAR Medical announced today that the FDA granted investigational device exemption to start a pivotal trial with its MINIject implant. Wavre, Belgium–based iStar’s MINIject minimally invasive implant for glaucoma surgery will be investigated in the STAR-V study, enrolling over 350 patients with primary open-angle glaucoma. MINIject combines the porous structure of iSTAR’s proprietary STAR material […]

Filed Under: Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Implants, Optical/Ophthalmic Tagged With: FDA, iSTAR Medical

FDA accepts biologics license application for Genentech’s drug-eluting eye implant

June 24, 2021 By Sean Whooley

Genentech Susvimo PDS implant

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 […]

Filed Under: Auto-injectors, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Optical/Ophthalmic, Pharmaceuticals Tagged With: Genentech, Roche

Glaukos completes enrollment in Phase 3 trials for iDose TR drug-eluting implant

June 10, 2021 By Sean Whooley

Glaukos logo

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 […]

Filed Under: Clinical Trials, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Optical/Ophthalmic Tagged With: FDA, Glaukos

FDA accepts resubmitted NDA for Xipere from Clearside Biomedical, Bausch Health

June 2, 2021 By Sean Whooley

Bausch_Health_ Clearside Biomedical

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 […]

Filed Under: Business/Financial News, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Optical/Ophthalmic, Pharmaceuticals Tagged With: Bausch Health, Clearside Biomedical, FDA

Noveome Biotherapeutics inks licensing deal for SipNose drug delivery device

June 1, 2021 By Sean Whooley

Noveome SipNose

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 […]

Filed Under: Business/Financial News, Clinical Trials, Drug-Device Combinations, Featured, Neurological, Optical/Ophthalmic, Otolaryngology Ear, Nose & Throat Tagged With: Noveome Biotherapeutics, SipNose

Glaukos expands microshunt licensing agreement with Santen Pharmaceuticals

May 19, 2021 By Sean Whooley

Glaukos-Santen

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 […]

Filed Under: Business/Financial News, Drug-Device Combinations, Featured, Optical/Ophthalmic, Pharmaceuticals Tagged With: Glaukos, santenpharmaceutical

Ocular Therapeutix misses The Street on bottom-line leap

May 6, 2021 By Nancy Crotti

Ocular Therapeutix logo

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% […]

Filed Under: Business/Financial News, Drug-Device Combinations, Featured, MassDevice Earnings Roundup, Optical/Ophthalmic, Pharmaceuticals, Wall Street Beat Tagged With: Ocular Therapeutix

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