Ophthalmology

Genentech’s Susvimo is a refillable implant that delivers medication continuously for up to six months.

Tyrvaya is a twice daily nasal spray, a first for the treatment of dry eye disease.

Biogen/Samsung Bioepis’ Byooviz is a biosimilar of Genentech’s Lucentis.

Three commercial plans now cover the corticosteroid Eysuvis.

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.

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.

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

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

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)

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

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

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.

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

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.

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

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

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.

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.

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.

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.

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

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).

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

Fluoroquinolone approved for bacterial conjunctivitis

Broad-spectrum antibiotic available as ophthalmic solution

FDA approval of this prescription eye drop makes it the first and only prostaglandin with a first-line indication for the treatment of elevated intraocular pressure (IOP) associated with open-angle glaucoma or ocular hypertension. Initially, latanoprost was only approved for second-line use.

New formulation: Drug increases tear production in patients with chronic dry eye due to ocular inflammation

New Indication: Light-activated ophthalmic cleared for CNV due to two additional causes