Ocular Therapeutix (NSDQ:OCUL) said today that the FDA accepted the company’s resubmitted New Drug Application for its post-surgical ocular pain reliever, Dextenza. The hydrogel plug, inserted into a patient’s tear duct, is designed to deliver a sustained dose of dexamethasone over 4 weeks following opthalmic surgery. The Bedford, Mass.-based company has had trouble gaining regulatory approval […]
Optical/Ophthalmic
Clearside enrolls first patient in phase III trial of Zuprata combination therapy
Clearside Biomedical (NSDQ:CLSD) said today that it enrolled the 1st patient in a phase III trial evaluating Zuprata, its suspension formulation of triamcinolone acetonide, in combination with Eylea for the treatment of macular edema associated with retinal vein occlusion. The trial is slated to enroll 460 patients with retinal vein occulsion to assess the efficacy […]
Pixium logs German reimbursement win for Iris II ‘bionic eye’
Pixium Vision (EPA:PIX) said today that its Iris II ‘bionic eye’ won NUB 1 reimbursement status from the German Institute for the Hospital Remuneration System. The company’s epi-retinal implant has 150 electrodes and a bio-inspired camera intended for patients who have lost sight due to retinitis pigmentosa. A computer processes images captured by the camera and […]
pSivida shares gain on Q2 earnings
Shares in pSivida (NSDQ:PSDV) rose yesterday after the medical device maker met expectations on Wall Street with its fiscal 2nd quarter results. The Watertown, Mass.-based company pared its losses to -$0.1 million, or 0¢ per share, on sales of $6 million for the 3 months ended Dec. 31, for bottom-line growth of 98.7% on sales […]
Second Sight announces upcoming rights offering
Second Sight Medical (NSDQ:EYES) today released information on an upcoming rights offering, with plans to open on February 10, with proceeds slated to support development and improvement of its Argus II retinal prosthesis. The Argus II induces visual perception in blind patients with retinitis pigmentosa by stimulating of the retina’s remaining cells with electrical pulses, which […]
Aura Biosciences wins FDA nod for light-activated ocular melanoma treatment
Aura Biosciences said today that the FDA approved its Investigational New Drug Application for the company’s light-activated viral nanoparticle conjugates for the treatment of ocular melanoma. The federal watchdog’s approval allows Cambridge, Mass.-based Aura to move forward with initial clinical tests of AU-011. The Phase Ib open-label clinical trial, which is currently enrolling, is designed to […]
Second Sight wins German reimbursement for Argus II retinal prosthesis
Second Sight Medical (NSDQ:EYES) said today it won reimbursement coverage for its Argus II epiretinal prosthesis from the German Institute for the Hospital Renumeration System, covering 15 hospitals in the group’s NUB1 innovation program. The Argus II induces visual perception in blind patients with retinitis pigmentosa by stimulating of the retina’s remaining cells with electrical pulses, which […]
Sales, earnings slide for Hoya’s life care business
Sales and earnings declined during the fiscal 3rd quarter for Hoya Corp. (TYO:7741), which reported an overall profit gain for the period despite falling sales. The Japanese conglomerate’s life care segment, which includes its eye care and endoscopy businesses, reported pre-tax profits of roughly $123.6 million (¥12.89 billion) on sales of $700.5 million (¥78.71 billion) for […]
Presbia prices $13.5m rights offering
Presbia (NSDQ:LENS) today priced an upcoming rights offering, looking to offer up to 4.5 million shares at $3 per share, netting the company as much as $13.5 million. The offering will go out to current shareholders, with 0.33 subscription rights being offered for each ordinary share owned. The offering will begin on Feb. 6, 2017 and […]
Report: Novartis eyes sale for Alcon lens business
Novartis (NYSE:NVS) said yesterday that it is considering selling its Alcon eye care business and will buy back up to $5 billion worth of shares over the next 12 months, in an effort to reorganize after a tough year. The company’s profits dropped -11% to $936 million in the 3 months ended Dec. 31, while sales […]
Ocular Therapeutix looks to raise $25m in public offering
Ocular Therapeutix (NSDQ:OCUL) said today that it launched a $25 million underwritten public offering of its common stock. The Bedford, Mass.-based company did not provide any specific pricing details for the offering. Cantor Fitzgerald & Co. is the sole bookrunner for the offering, according to regulatory filings. Yesterday, the company said today that it resubmitted a […]