New Introductions - Internationally

FDA Approves Besifloxacin for Bacterial Conjunctivitis

The US Food and Drug Administration (FDA) has approved besifloxacin 0.6% ophthalmic suspension for the treatment of bacterial conjunctivitis caused by susceptible isolates of CDC coryneform group G, Corynebacterium pseudodiphtheriticum , Corynebacterium striatum , Haemophilus influenza , Moraxella lacunata , Staphylococcus aureus , Staphylococcus epidermidis , Staphylococcus hominis , Staphylococcus lugdunensis , Streptococcus mitis group, Streptococcus oralis , Streptococcus pneumonia , and Streptococcus salivarius bacteria.

Approval of this topical fluoroquinolone was based primarily on data from a randomized, double-blind, multicenter clinical trial of patients aged 1 to 98 years, showing that use of besifloxacin was significantly more effective for achieving clinical resolution of bacterial conjunctivitis symptoms than the non medicated vehicle alone (45% vs. 33%; 95% confidence interval, 3% – 22%). Microbiologic outcomes also revealed a statistically significant increase in eradication rate for causative pathogens (91% vs. 60%).

Source: www.medscape.com Accessed on 19/11/2009

FDA Approves Ganciclovir Ophthalmic Gel for Dendritic Ulcers

The U.S. Food and Drug Administration have approved ganciclovir ophthalmic gel 0.15% as a topical treatment for acute herpetic keratitis.

The FDA's action was based on data from an open-label, randomized clinical trial (n = 164) and 3 randomized, single-blind studies (n = 213) conducted in Europe and Asia, showing that ganciclovir 0.15% ophthalmic gel was non inferior to acyclovir 3% ophthalmic ointment for achieving clinical resolution of dendritic ulcers at day 7 (77% vs. 72% and 72% vs. 69%, respectively). Both are standard-of-care therapies outside of the United States and selectively target herpes simplex virus DNA replication.

The recommended dosing regimen for ganciclovir ophthalmic gel is 1 drop instilled in the affected eye 5 times daily until the ulcer heals, and then 1 drop 3 times daily for 7 days. Adverse events most commonly reported in clinical trials included blurred vision (60%), eye irritation (20%), punctate keratitis (5%), and conjunctival hyperemia (5%).

Source: www.medscape.com Accessed on 19/11/2009

FDA Approves Bepotastine Ophthalmic Solution for Treating "Allergy Eyes"

The FDA has approved bepotastine besilate 1.5% ophthalmic solution for the twice-daily treatment of ocular itching associated with allergic conjunctivitis in patients aged 2 years and older.

Approval of the histamine H1 receptor antagonist was based primarily on data from 2 phase 3 double-blind, conjunctival allergen challenge studies (n = 237) showing that bepotastine significantly decreased ocular itching relative to use of the vehicle alone at 15 minutes and 8 hours post dose.

Adverse events reported in 2% to 5% of treated patients included eye irritation, headache, and nasopharyngitis.

Source: www.medscape.com Accessed on 19/11/2009

FDA Approves Bimatoprost 0.03% for Treatment of Hypotrichosis of Eyelashes

The U.S. Food and Drug Administration has granted full approval to a 0.03% formulation of bimatoprost ophthalmic solution for the treatment of hypotrichosis of eyelashes

According to results from a multicenter, double-masked, placebo-controlled phase 3 clinical trial, when the once-daily treatment of bimatoprost 0.03% was applied to the base of the upper eyelashes, patients exhibited more prominent and thicker, longer and darker eyelashes. The trial also showed the safety of bimatoprost 0.03% in this application, according to the release.

Additional safety data on bimatoprost 0.03% for treatment of hypotrichosis of eyelashes was extracted from experience with its primary ingredient, bimatoprost, in the treatment of other ocular disorders. Bimatoprost was first approved in 2001 for lowering IOP in patients with open-angle glaucoma or ocular hypertension; some patients treated for glaucoma with bimatoprost experienced eyelash growth as a side effect.

Source: www.osnsupersite.com accessed on 30 th December 2008

Difluprednate ophthalmic emulsion 0.05% Is First Ophthalmic Steroid Indicated for Inflammation and Pain

The U.S. Food and Drug Administration (FDA) has approved the new drug application for difluprednate ophthalmic emulsion 0.05%, a topical steroid for the treatment of postoperative ocular inflammation and pain. The approval came after a six month priority review.

Difluprednate ophthalmic emulsion 0.05% is a potent topical steroid that works rapidly and effectively to resolve postoperative inflammation and pain.

It is the first steroid to have an indication for the treatment of postoperative pain. Having access to a steroid that treats both inflammation and pain gives physicians a more complete treatment approach."

In two Phase 3 trials evaluating difluprednate ophthalmic emulsion 0.05% in patients diagnosed with significant postoperative inflammation (more than 10 anterior chamber cells), difluprednate rapidly reduced inflammation and pain. Mean intraocular pressure (IOP) for all study groups remained within the normal range throughout the study.

The results from phase 3 studies, particularly the ability to eliminate postoperative pain demonstrate that difluprednate is a powerful option for postoperative care.

AMO Receives FDA Clearance For Fifth-Generation Femtosecond Laser

Advanced Medical Optics has received U.S. Food and Drug Administration clearance for its fifth-generation IntraLase femtosecond laser.

The fifth-generation model — called the iFS advanced femtosecond laser — is capable of creating a corneal flap in less than 10 seconds and features an inverted bevel-in side cut angle designed to enhance flap lift, increase postoperative flap adhesion and improve the biomechanical stability of the cornea. The laser is also capable of performing fully customized IntraLase-enabled keratoplasty, the release said.

Compared with prior models, the fifth-generation platform features a faster repetition rate, tighter spot separation, lower energy, a high-resolution digital video microscope and a newly designed user interface.

The model is also ergonomically designed to improve surgeon comfort.

FDA approves Brimonidine Tartrate- Timolol Maleate Fixed Dose Combination for Inadequately Controlled IOP

On October 30, the FDA approved brimonidine tartrate/timolol maleate 0.2%/0.5% topical ophthalmic solution to reduce intraocular pressure (IOP) in patients with glaucoma or ocular hypertension who require adjunctive or replacement therapy because of inadequately controlled IOP.

The recommended dosing for the alpha-adrenergic–receptor agonist plus beta-adrenergic–receptor inhibitor topical solution is 1 drop in the affected eye approximately every 12 hours; at least 5 minutes should elapse before and after administration of another topical product.

Use in children aged younger than 2 years is not recommended.

Approval of the combination product was based on data from 12-month pivotal trials, showing its use provided an additional decrease of 1 to 3 mm Hg in IOP vs brimonidine alone and an additional decrease of 1 to 2 mm Hg vs timolol alone during the first 7 hours after dosing.

Although the IOP-lowering effect of the combination product was slightly less than that of combination therapy with twice-daily timolol 0.5% solution and 3 times daily brimonidine 0.2% solution, it was associated with a decreased level of self-reported sleepiness in patients aged older than 40 years.

Adverse events reported in approximately 5% to 15% of patients using brimonidine/timolol solution included allergic conjunctivitis, conjunctival folliculosis, conjunctival hyperemia, eye pruritis, ocular burning, and stinging.