Ophthalmology

FDA approves combination glaucoma drop without beta-blocker

April 23, 2013

FDA approved a new fixed-dose combination ophthalmic suspension of a carbonic anhydrase inhibitor (brinzolamide 1.0%) and an alpha 2 adrenergic receptor agonist (brimonidine tartrate 0.2%), which is indicated for the reduction of intraocular pressure in patients with primary open-angle glaucoma or ocular hypertension.

Zioptan (Tafluprost 0.0015% ophthalmic solution): An opthalmic solution to reduce elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension

July 01, 2012

New molecular entity: FDA approved tafluprost 0.0015% (Zioptan, Merck) ophthalmic solution to reduce elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

FDA Actions in Brief May 2012

June 01, 2012

Recent FDA Approvals (through May 2012) related to (Meda, Novo Nordisk, Janssen, Vivus, Clinigen, GlaxoSmithKline, Stride Arcolab)

FDA Actions in Brief April 2012

May 01, 2012

Recent FDA Approvals (through April 2012) related to (Johnson & Johnson, AstraZeneca, Affymax, Takeda Pharmaceutical, Teva Pharmaceutical Industries, Avioq, Hope Pharmaceuticals, Novo Nordisk, Avid Radiopharmaceuticals)

FDA Actions in Brief March 2012 (Corcept Therapeutics, Merck, Amylin Pharmaceuticals, Alkermes, Sanofi, Mobius Therapeutics, Vertex Pharmaceuticals, Boehringer Ingelheim, Eli Lilly, Pfizer, UCB, Curis, Genentech, Novartis)

March 01, 2012

Recent FDA Approvals (through February 2012) related to (Corcept Therapeutics, Merck, Amylin Pharmaceuticals, Alkermes, Sanofi, Mobius Therapeutics, Vertex Pharmaceuticals, Boehringer Ingelheim, Eli Lilly, Pfizer, UCB, Curis, Genentech, Novartis)

Aflibercept (Eylea): A monthly intravitreal injection for wet age-related macular degeneration (AMD)

February 01, 2012

New molecular entity: Aflibercept once-monthly intravitreal injection is FDA approved to treat patients with wet (neovascular) age-related macular degeneration.

FDA Pipeline Preview, January 2012 (Alexza Pharmaceuticals, Pfizer, Celladon, Vertex, Avedro)

January 01, 2012

Recent FDA action (through December 2011) related to staccato loxapine, axitinib, mydicar, kalydeco, riboflavin ophthalmic solution, minocycline hydrochloride

Ranibizumab and bevacizumab show equivalent effects on visual acuity in patients with neovascular AMD

June 01, 2011

Two of the most commonly used treatments for neovascular age-related macular degeneration, ranibizumab, approved by FDA in 2006, and the other commonly used 'off-label', bevacizumab, resulted in similar improvements in visual acuity, according to results of a new trial.

First-time generic approval June 2011

June 01, 2011

Generic drugs approved by FDA (through May 2011): bromfenac ophthalmic solution 0.09%, sodium ferric gluconate complex in sucrose injection, nitrofurantoin oral suspension

Ranibizumab and bevacizumab have equivalent effect on neovascular AMD

May 13, 2011

Two of the most commonly used treatments for neovascular AMD, ranibizumab (Lucentis, Genentech), approved in 2006 by FDA, and the other commonly used ?off-label,? bevacizumab (Avastin, Genentech), resulted in similar improvements in visual acuity, according to a new randomized controlled trial published in NEJM.

First-time generic approval May 2011

May 01, 2011

Generic drug approved by FDA (through May 2011): Latanoprost

Drug Watch: Eye diseases (PDF) (December 2010)

December 01, 2010

Agents in late-stage development for the treatment of eye diseases.

FDA approves first once-daily eyedrop for inflammation and pain after cataract surgery

November 12, 2010

Bromfenac ophthalmic solution (Bromday, ISTA Pharmaceuticals) 0.09% has been granted FDA approval as a once-daily prescription eyedrop for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract extraction.

Increased cataracts risk in elderly associated with SSRIs, SNRIs

July 01, 2010

In an on-line article published in the journal Ophthalmology, researchers reported a possible adverse association between certain selective serotonin reuptake inhibitors (SSRIs) and serotonin and norepinephrine reuptake inhibitors (SNRIs) and the development of cataracts in those aged >65.

Travoprost: A prostaglandin analogue for the treatment of glaucoma

November 01, 2009

In August 2003, the US Department of Veterans Affairs (VA) awarded a contract for prostaglandin ophthalmic agents with travoprost as the agent of choice. Although there was no national mandate to switch patients from existing therapy, many VA facilities had agreements from their local ophthalmology and optometry departments to conduct a therapeutic interchange of patients from existing prostaglandins (eg, latanoprost) to travoprost.

Statins associated with reduction in 10-year risk of cataracts

November 01, 2007

In the Blue Mountains Eye Study published in the American Journal of Ophthalmology, statin use was demonstrated to be protective against the development of cataracts, reducing a patient's risk by nearly half.

AzaSite: New formulation recently approved by FDA for azithromycin ophthalmic solution 1%

June 01, 2007

A new formulation for azithromycin, an antibacterial agent, is now approved by FDA for the treatment of bacterial conjunctivitis.

Lucentis

August 01, 2006

This recombinant humanized IgG1 monoclonal antibody fragment binds to the receptor-binding site of active forms of human vascular endothelial growth factor A (VEGF-A).

Xibrom

May 01, 2005

Twice-daily ophthalmic NSAID approved to reduce inflammation after cataract surgery

Zymar (Gatifloxacin ophthalmic solution, 0.3%)

June 01, 2003

Fluoroquinolone approved for bacterial conjunctivitis