Presbia (Nasdaq:LENS) said today that it has successfully completed the ISO 13485:2016 audit with no major findings. Officials at the Dublin, Ireland–based ophthalmic device company described the audit completion as an essential step toward recertifying under the ISO standard. The company – which has administrative offices and manufacturing in Irvine, Calif. – will receive annual surveillance […]
SightGlass Vision launches trial for pediatric myopia-controlling eyeglasses
Opthalmalogical device maker SightGlass Vision said yesterday that it launched a pivotal clinical trial exploring the use of its novel lenses designed to reduce the rate of progression in children between six and nine years old. The Palo Alto, Calif.-based company’s Cypress trial is a multicenter, double-blinded, randomized controlled clinical trial that aims to enroll […]
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. Get the full story at our sister site, Drug Delivery […]
Results RNA recalls eye drops over undeclared colloidal silver
Results RNA said this week that it voluntarily recalled its Lubrisine eye drops following an FDA inspection that found the product was not manufactured with sterile practices. The company also said that the eye drops, which are designed to lubricate dry eyes, were found to contain undeclared colloidal silver. Exposure to colloidal silver over an extended […]
Ocular Therapeutix lands $25m term loan
Ocular Therapeutix (NSDQ:OCUL) said today that it closed a refinancing of its existing debt by landing a $25 million term loan with MidCap Financial and Silicon Valley Bank. The 5-year term loan facility expanded the company’s prior $18 million credit facility to $25 million. The proceeds from the loan were used to repay the $12.3 million […]
Novartis unit Alcon picks up Tear Film Innovations
Novartis (NYSE:NVS) subsidiary Alcon said it acquired Tear Film Innovations for an undisclosed amount. San Diego-based TFI makes the iLux system, which is designed to treat blocked meibomian glands in eyelids. The company had raised a total of $18 million in two rounds in as many years, split evenly between the two. iLux won 510(k) clearance from the FDA […]
LumiThera inks Italian Valeda distro deal
LumiThera said today that it inked a deal with ophthalmology distributor Miloftalmica to be the exclusive distributor of the Valeda light delivery system, intended to treat dry age-related macular degeneration, across Italy. Therapy using the Valeda light delivery system consists of a series of light-based treatments to the retinal cells, which Seattle-based LumiThera claims improves […]
Feds drop insider trading, perjury charges against ex-AMO chief Mazzo
Federal prosecutors this week dropped perjury and insider trading charges against former Advanced Medical Optics CEO James Mazzo related to AMO’s $2.8 billion acquisition by Abbott (NYSE:ABT) in 2009 in light of two hung juries, according to court documents. Judge Andrew Guilford for the U.S. District Court for the Central District of California ordered a dismissal with prejudice for Mazzo this […]
Alimera Sciences wins Health Canada nod for diabetic macular edema implant
Alimera Sciences (NSDQ:ALIM) said last month that it won approval in Canada for its intravitreal implant designed to treat diabetic macular edema. The Iluvien device is a sustained release implant that delivers fluocinolone acetonide and is indicated to treat diabetic macular edema in people who have been previously given corticosteroids and did not have a clinically […]
Notal Vision snags breakthrough designation for home OCT system
Ophthalmic diagnostic services company Notal Vision said it has won breakthrough device designation for its artificial-intelligence-aided macular degeneration diagnostic device. Privately-held Notal (Manassas, Va.) said its home-based optical coherence tomography (OCT) system was designed to automatically identify intra- and/or subretinal fluid in the central 10 degrees of eyes diagnosed with exudative age-related macular degeneration (eAMD). The Notal Home […]
Eyenovia kicks off second Ph3 trial for pupil dilation tech
Eyenovia (NSDQ:EYEN) said this week that it finished patient enrollment in its Phase III Mist-1 trial and enrolled the first patient in its second Phase III trial for the company’s combination eye solution delivered as a micro-dose using its Optejet device. The company is studying the therapy for pharmacologic mydriasis – pupil dilation for eye exams. […]
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