Alcon riding high from AcrySof designation

July 1, 2006

The Centres for Medicare and Medicaid Service (CMS) has recognized Alcon's AcrySof IQ intraocular lens (IOL) as belonging to the New Technology IOL (NTIOL) classification of Reduced Spherical Aberration.

The NTIOL designation became effective as of May 19 this year and will increase the Medicare payment to ambulatory surgery centres for cataract surgery by $50, when surgery is performed with the AcrySof lens.

AcrySof is an aspheric lens designed to reduce spherical aberration and it has been shown to improve night driving performance.

The European Commission has granted permission to Allergan to market its combination glaucoma treatment, Ganfort, in the European Union.

Ganfort (bimatoprost/timolol ophthalmic solution) is indicated for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to topical beta-blockers or prostaglandin analogues.

The combination of bimatoprost 0.03% and timolol maleate 0.5% has been proven to offer greater efficacy than the two agents used alone. In addition, the once daily dose is thought to improve patient compliance, a key factor in controlling glaucoma.

The new license will now enable Allergan to market the treatment across Europe.

Lucentis gets the green light in the US

The eagerly anticipated approval comes as welcome news to the majority of retina specialists throughout the US, some of whom have been administering the colon cancer drug Avastin (bevacizumab) off-label to treat their neovascular AMD patients.

Avastin was first used on human eyes by Philip Rosenfeld, MD from the Bascom Palmer Eye Institute in Miami, USA who, along with his team, managed to expose a more favourable, potentially less toxic way of administering the approved therapy to a population of patients. With the safety and efficacy of the off-label candidate being demonstrated in a number of small-scale studies, and because of the low price associated with intravitreal injections of the cancer drug, naturally many began administering Avastin to patients. However, prior to Lucentis' approval, many admitted that they would switch to Lucentis therapy once it was approved because the long-term safety record of Avastin for the treatment of ophthalmic conditions was still unknown. Furthermore, should complications ensue as a result of off-label treatment, the ophthalmologist may be subject to legal investigation.

The FDA approval of Lucentis is based on data from two Phase III clinical trials (MARINA and ANCHOR), which found that 95% of patients treated with Lucentis maintained vision and that 40% of these actually gained 15 letters. In the MARINA study, subjects experienced an improvement from baseline of 6.6 letters at two years compared with a loss of 14.9 letters in the control group. The ANCHOR study found that Lucentis patients gained 11.3 letters from baseline at one year compared with a loss of 9.5 letters in the group being treated with photodynamic therapy (PDT). Up to 40% of patients treated with Lucentis achieved vision of 20/40 or better.

In addition to the data from the two pivotal studies, data from the Phase IIIb PIER study was also included. This study examined two doses (0.3 mg and 0.5 mg) injected once a month for the first three months followed thereafter by doses once every three months for 24 months. By month twelve, both doses resulted in maintained vision as opposed to subjects in the sham group who had lost and average of 16.3 letters.

The FDA has recommended Lucentis 0.5 mg for intravitreal injection once a month. If monthly injections are not feasible, treatment can be reduced to once every three months after four initial monthly treatments.

Lucentis is a humanized therapeutic antibody fragment designed to bind and inhibit VEGF-A, a protein that is believed to play a critical role in angiogenesis.