AMD controversy sparks debate

AAO 2005 15–18 ctober 2005

The 2005 annual meeting of the American Academy of Ophthalmology (AAO) saw the event record the third highest attendance figures in its history. With the Chicago meeting opening its doors to almost 26,000 attendees, overall attendance was up 2% over the previous year, whilst the number of International attendees rose by 18% on 2004 figures.Below is a glimpse at some of the presentations and announcements made during the meeting.

Retaane safe and effective at 24 months

In a comparative study with Visudyne photodynamic therapy (PDT), Retaane 15 mg (anecortave acetate suspension) induced no clinically relevant adverse events during the trial period and mean visual acuity reported in both treatment groups was clinically stable from month 12 to month 24. Retaane has therefore been shown to be equally efficacious and safe in treating wet AMD patients, when compared with Visudyne PDT.

Retaane suspension is an angiostatic cortisene that acts through angiogenesis inhibition to treat wet AMD. The investigational candidate is derived from a steroid that has been engineered to remove chemical groups responsible for known side effects associated with the drug class, such as cataract development and elevated intraocular pressure.

The suspension is administered once every six months behind the eye with a blunt-tipped, curved cannula. This route of administration avoids risk of infection and retinal detachment.

The FDA has issued Alcon an approvable letter for the company's NDA and approval is also being pursued in the EU, Canada, Switzerland and Australia.

Evizon + Visudyne = a good combination therapy in AMD

Genaera Corporation's Evizon (squalamine lactate) in combination with photodynamic therapy (PDT; Visudyne) is a safe and effective treatment for wet AMD, according to preliminary study results.

The exploratory, multi-centre, randomized, double-masked, US Phase II trial (MSI-1256F-208) in 45 subjects met its primary goal of demonstrating safety when administered simultaneously with PDT, with no serious adverse events reported.

Preliminary analysis of the results showed patients treated with 40 mg Evizon plus PDT at 29 weeks had a slight increase in mean visual acuity, in comparison to the PDT-alone group, which demonstrated a decrease in mean visual acuity from baseline. Further, vision (defined as a gain or loss of less than 15 letters in visual acuity) was maintained in around 90% of subjects in the Evizon plus PDT group and, of those in the combination group, 10% required a second PDT treatment compared with 47% in the PDT-alone arm.

Evizon is a systemically administered, synthetic small molecule that inhibits VEGF, integrin expression and reverses cytoskeletal formation thereby disrupting various stages of the angiogeneic process. In 2004, Evizon was granted fast-track designation by the FDA and was selected in January 2005 by the governing body for participation in the Continuous Marketing Application (CMA) Pilot 2 programme.

There are currently several studies ongoing with Evizon, including a Phase IIII and multiple Phase II trials.

New technology launched to enhance intraoperative control in cataract surgery

WhiteStar ICE technology has been designed for use in the Sovereign phacoemulsification system to increase surgeon cutting power without increasing ultrasonic energy use. AMO's WhiteStar technology is already used to deliver "cold" phaco energy for cataract removal with virtually no thermal complications.

The technology utilises CASE (Chamber Stabilization Environment) technology that enables surgeons to optimize fluidics during cataract removal whilst reducing surge on occlusion break by adjusting vacuum before the occlusion breaks to reduce chamber shallowing and maintain chamber stability.