17:59 , Apr 13, 2018 |  BC Week In Review  |  Clinical News

Ocugen reports Phase II data for dry eye disease candidate

Ocugen Inc. (Malvern, Pa.) reported data from a Phase II trial showing that dry eye disease candidate OCU310 met the primary endpoint of tolerability over a 12-week period. The company said the trial was not...
07:00 , May 23, 2016 |  BioCentury  |  Strategy

Two heads are better

With Gleevec imatinib off patent, flagging ophthalmics sales and at least one slower than expected launch, Novartis AG is consolidating operations at the top to cut costs, while also splitting its R&D into two buckets:...
07:00 , Aug 11, 2014 |  BC Week In Review  |  Clinical News

Simbrinza brinzolamide/brimonidine tartrate regulatory update

Novartis’ Alcon Inc. ophthalmic unit said the European Commission approved an MAA for Simbrinza brinzolamide/brimonidine tartrate to reduce intraocular pressure (IOP) in adults with open-angle glaucoma or ocular hypertension for whom monotherapy provides an insufficient...
07:00 , Jun 9, 2014 |  BC Week In Review  |  Clinical News

Simbrinza brinzolamide/brimonidine tartrate regulatory update

EMA's CHMP recommended approval of an MAA from Novartis' Alcon Inc. ophthalmic unit for Simbrinza brinzolamide/brimonidine tartrate to reduce intraocular pressure (IOP) in patients with primary open-angle glaucoma or ocular hypertension for whom monotherapy provides...
07:00 , Jun 5, 2014 |  BC Innovations  |  Targets & Mechanisms

De-stressing glaucoma

Glucocorticoids are standard of care for a host of allergic and inflammatory eye conditions, but they elevate intraocular pressure about a third of the time and can result in secondary open-angle glaucoma. A chemical chaperone...
08:00 , Mar 3, 2014 |  BC Week In Review  |  Clinical News

Mirvaso brimonidine tartrate regulatory update

The European Commission approved an MAA from Galderma for Mirvaso brimonidine tartrate for the symptomatic treatment of facial erythema of rosacea in adult patients. Galderma launched the product in the U.S. in September. Mirvaso is...
08:00 , Jan 6, 2014 |  BC Week In Review  |  Clinical News

Mirvaso brimonidine tartrate regulatory update

On Dec. 19, 2013, EMA's CHMP issued a positive opinion recommending approval of an MAA from Galderma for Mirvaso brimonidine tartrate for the symptomatic treatment of facial erythema of rosacea in adult patients. Galderma launched...
07:00 , Oct 7, 2013 |  BC Week In Review  |  Company News

Galderma sales and marketing update

Galderma launched Mirvaso brimonidine tartrate 0.33% in pharmacies in the U.S. to treat facial erythema of rosacea in adult patients. A 30 g tube of the product, which was approved by FDA in August, has...
07:00 , Sep 2, 2013 |  BC Week In Review  |  Clinical News

Mirvaso regulatory update

Galderma said FDA approved an NDA from Galderma for once-daily Mirvaso topical gel 0.33% to treat facial erythema of rosacea in adult patients. The company expects the product to be available in pharmacies this month....
07:00 , Jun 24, 2013 |  BC Week In Review  |  Clinical News

Brimonidine tartrate: Phase III data

A pair of identical, double-blind, U.S. and Canadian Phase III trials in patients with moderate to severe erythema associated with rosacea showed that once-daily 0.5% topical brimonidine tartrate gel for 4 weeks met the primary...