SofPort lenses win N TIOL status

Bausch & Lomb has received new technology intraocular lens (NTIOL) status for the regular and violet-filtering models of its SofPort Advanced Optics intraocular lenses (IOLs).

The Centers for Medicare and Medicaid Services (CMS) in the US has increased the current reimbursements for both lenses by $50. Only ASC-based surgeons are entitled to this additional reimbursement, however, this does represent a large portion of the cataract procedures performed in the US.

According to Bausch & Lomb, this new reimbursement will cover the entire cost of the IOLs, which means that patients will no longer have to pay for any additional costs.

The increased reimbursements will remain in effect until February 26, 2011.

Pfizer's novel glaucoma candidate goes to trial

Pfizer has initiated the first in a series of planned clinical trials for PF-03187207, a new experimental medicine for the treatment of glaucoma.

The Phase II, dose-finding study, will compare the safety and efficacy of PF-03187207 to latanoprost over a 28-day period. The randomized, double-masked study is expected to enrol 150 subjects with primary open angle glaucoma or ocular hypertension in one or both eyes.

PF-03187207 is the lead development compound generated under the August 2004 collaboration agreement between NicOx and Pfizer, which focuses on the research and development of nitric oxide-donating prostaglandin F2-alpha analogues for the treatment of glaucoma.

The initiation of the clinical trial follows the granting of an Investigational New Drug (IND) approval by the FDA, which in turn results in a €1 million milestone payment from Pfizer to NicOx.

Azithromycin proving its worth

Azithromycin is just as effective and safe as tobramycin for the treatment of purulent bacterial conjunctivitis, according to a report published in the April issue of the British Journal of Ophthalmology.

Isabelle Cochereau from CHU d'Angers, France and colleagues from Tunisia, Morocco, Romania and India conducted a multicentre, randomized, investigator-masked study, which included 1,043 children and adults with purulent bacterial conjunctivits. Patients were randomized to receive either azithromycin 1.5% twice-daily for three days or tobramycin 0.3%, one drop every two hours for two days and then four times daily for five days. Clinical signs were evaluated and cultures obtained at baseline and three and nine days following the commencement of treatment.

Among 471 patients with baseline positivity, 87.8% of the azithromycin group and 89.4% of the tobramycin group were clinically cured by the final examination. Clinical cure was, however, significantly higher with azithromycin at day three.

It was concluded that azithromycin is just as effective as tobramycin for treating purulent bacterial conjunctivitis. Additionally, it only requires a twice-daily dosing regimen, which should help increase patient compliance.

FDA denies Lilly appeal

Lilly has also decided to withdraw Arxxant's marketing application from the European Medicines Agency (EMEA), where it was undergoing review by the Committee for Medicinal Products for Human Use (CHMP). Although CHMP did explicitly request new studies, it had asked for additional safety and efficacy data within a timeframe that Lilly was unable to meet.

Lilly is still evaluating Arxxant in two trials for diabetic macular oedema and is currently deciding how to progress with the drug as a treatment for diabetic retionapthy.