Stop press: Lucentis and Avastin to go head-to-head

November 1, 2006

The National Eye Institute (NEI), part of the US National Institute for Health, is to fund a clinical trial comparing Lucentis (ranibizumab) and Avastin (bevacizumab).

The National Eye Institute (NEI), part of the US National Institute for Health, is to fund a clinical trial comparing Lucentis (ranibizumab) and Avastin (bevacizumab).

Lucentis was approved by the FDA earlier this year as a treatment for wet age-related macular degeneration (AMD). The approval was based on clinical trial results demonstrating its ability to slow the progression of the disease and to actually improve vision in around one-third of subjects.

Avastin is currently approved as a treatment for colorectal cancer, but is closely related to Lucentis. Despite not being approved for ophthalmic use, doctors have been using it off–label to treat advanced wet AMD. The comparative study will assess the relative safety and efficacy of the two drugs.

Acuity's AMD drug shows further promise

Acuity Pharmaceuticals released promising Phase II clinical results for its wet age-related macular degeneration (AMD) treatment, bevasiranib (Cand5), at the 24th Annual Meeting of the American Society of Retina Specialists in Cannes, France.

The Cand5 Anti-VEGF RNAi Evaluation (CARE study) was a randomized, double-masked trial that investigated three dose levels of the company's small interfering RNA therapeutic, on 129 patients at 28 sites across the USA. The study focused on subjects with severe forms of the disease, classic or active minimally classic AMD and those patients who had failed to respond sufficiently to previous treatments.

Bevasiranib was found to be safe with all doses, well tolerated and most adverse events were mild and related to the administration procedure. No systemic adverse events were observed. Importantly, pharmacokinetic studies have confirmed that there was no systemic bevasiranib exposure in patients, an important factor for agents targeting vascular endothelial growth factor (VEGF).

Bevasiranib is designed to actually shut down the genes that produce VEGF unlike previous therapies that were developed to neutralize any VEGF that the eye had already produced.

Acuity is now looking forward to initiating Phase III trials once all the Phase II data has been thoroughly analysed.

Epi-K gets the okay

The Epi-K (Moria) Epi-LASIK system may be a safer option than traditional PRK treatments as there is a lower risk of ectasia, according to H.L. Milne, MD, of Columbia, USA, speaking at the 5th International Congress of Epi-LASIK, LASEK and Advanced Surface Ablation, London, UK.

Milne conducted a study of 100 eyes treated with the Epi-K and found that visual recovery was significantly faster than those cited by IntraLase consultants in their clinical assessment of wavefront-guided PRK performed using the "Durries Technique". Patients' vision was checked five minutes postoperatively and most recorded results of 20/40 or better and many 20/20 or better. One month postoperatively, patients' visual acuities were almost identical to those cited by IntraLase surgeons.

The Epi-K system discards the epithelial sheet and Dr Milne speculates that this may significantly improve visual outcomes as it eliminates the "Bowman's Wrinkle" produced in intrastromal procedures.

Milne believes that the safety profile and promising visual results of the Epi-K may eventually make it a standard in refractive surgery.

FDA deals Lilly another blow

The FDA has told Eli Lilly that it must conduct an additional three-year, Phase III clinical trial to establish ruboxistaurin mesylate's efficacy as a treatment for diabetic retinopathy before they will consider approving it.

Lilly believes that a trial of this kind could take up to five years to complete and is subsequently considering its options for the further development of the molecule. Ruboxistaurin (proposed brand name Arxxant) was originally submitted to the FDA in February of this year and granted a priority review. Since then an approvable letter was issued requesting additional efficacy data.

Lilly does not intend to withdraw its application, since this would require restarting the review process, and is currently reviewing the situation.