Aerie Pharmaceuticals (NSDQ:AERI) said today that it completed enrollment for its 2nd phase III registration trial, Mercury 2, evaluating its Roclatan once-daily eye drops for intraocular pressure resulting from glaucoma or ocular hypertension. The company’s Roclatan solution is a fixed dose combination of its drug Rhopressa (netarsudil ophthalmic solution) and latanoprost, a widely prescribed prostaglandin […]
Optical/Ophthalmic
OCUL registers for $40m stock sale
Ocular Therapeutix (NSDQ:OCUL) is looking to raise $40 million through a public stock offering, according to a prospectus filed with the federal Securities & Exchange Commission this week. The Bedford, Mass.-based company said it inked a controlled equity offering sales agreement with Cantor Fitzgerald & Co., and agreed to pay Cantor Fitzgerald commissions of up to 3% […]
FDA clears Allergan’s Xen gel stent for glaucoma
Allergan (NYSE:AGN) said today that it won FDA approval for its Xen gel stent and injector for glaucoma. The federal watchdog indicated the drug device for the management of refractory glaucoma, in cases where surgical treatment has failed or in patients with open angle glaucoma that is unresponsive to maximum tolerated medical therapy. The Dublin-based […]
Novartis backs off from 2016 date for testing Google autofocus lens
Novartis (NYSE:NVS) is reportedly backing off a 2016 start date to test its autofocusing contact lens in clinical trials, but it told Reuters that the product is “progressing steadily” in its collaboration with Google (NSDQ:GOOGL). In 2014, CEO Joe Jimenez said he hoped the lens would be on the market in 5 years and last year he said his […]
Clearside Biomedical launches trial for Zuprata
Clearside Biomedical (NSDQ:CLSD) said today that it enrolled the 1st patient in clinical trial of its suspension formulation of corticosteroid triamcinolone acetonide, Zuprata, for the treatment of diabetic macular edema. The Alpharetta, Ga.-based company’s Hulk Phase I/II trial is an open-label, multi-center study designed to evaluate the safety and efficacy Zuprata administered in the suprachoroidal space […]
OCUL’s Dextenza meets endpoints in pivotal study
Ocular Therapeutix (NSDQ:OCUL) said today that its post-surgical ocular pain reliever, Dextenza, met both primary endpoints in a pivotal trial for the treatment of post-surgical ocular inflammation and pain. The product is a bioresorbable intracanalicular insert, designed for drug release to the ocular surface for up to 30 days. The randomized, double-masked study enrolled 438 patients who were […]
Clearside tops Q3 estimates, posts license revenue
Shares in Clearside Biomedical (NSDQ:CLSD) rose today after the biopharmaceutical company met expectations on Wall Street with its 3rd quarter results. The Alpharetta, Ga.-based company posted losses of -$5.6 million, or -28¢ per share, on sales of $5,000 for the 3 months ended Sept. 30. This is the 1st quarter that Clearside has reported revenue. Adjusted to exclude […]
Ocular Therapeutix plans FDA re-submission for Dextenza by end of year, earnings
Shares in Ocular Therapeutix (NSDQ:OCUL) surged this morning after the biopharmaceutical company met expectations on Wall Street with its 3rd-quarter results and announced it will re-submit its new drug application to the FDA for Dextenza, its post-surgical ocular pain reliever, by the end of the year. In July, the FDA denied approval for Ocular’s hydrogel plug designed […]
pSivida misses Q1 estimates, profits slide 47%
Shares in pSivida (NSDQ:PSDV) fell 6% today after the company missed expectations on Wall Street with its fiscal 1st-quarter results*. The Watertown, Mass.-based company posted losses of -$7.2 million, or -21¢ per share, on sales of $277,000 for the 3 months ended Sept. 30, for a bottom-line loss of -47% on a -41% sales decline, compared […]
Clearside Biomedical names McElheny as biz dev veep | Personnel Moves, Nov. 8, 2016
Clearside Biomedical (NSDQ:CLSD) today named Rick McElheny as its VP of business development. The Alpharetta, Ga.-based company is developing a microinjector loaded with CLS-TA (triamcinolone acetonide) to treat macular edema. The device is designed to inject the compound in the a 30-µm gap between the choroid and the sclera, called the suprachoroidal space. A pivotal Phase III […]
