Lucentis gets first European approval

October 1, 2006

The Swiss authorities have approved Lucentis (ranibizumab) as a treatment for wet age-related macular degeneration (AMD), making Switzerland the first European country to do so.

The Swiss authorities have approved Lucentis (ranibizumab) as a treatment for wet age-related macular degeneration (AMD), making Switzerland the first European country to do so.

Lucentis is a therapeutic antibody fragment that is specifically designed to treat conditions of the eye by blocking all biologically active forms of vascular endothelial cell growth factor A (VEGF-A).

Novartis has also submitted Lucentis for approval in the European Union and Australia.

Lilly drug approval on hold for now

Eli Lilly has received an approvable letter from the FDA regarding its investigational drug, Arxxant (ruboxistaurin mesylate), for the treatment of diabetic retinopathy (DR).

The FDA has requested the submission of further data to support the clinical data presented by Lilly in its new drug application (NDA). The company plans to meet with the FDA to determine whether the new data can be provided from an ongoing study or whether a new study needs to be initiated.

Arxxant works by limiting the overaction of protein kinase C beta, a naturally occurring enzyme that has been linked with the development of DR.

US welcomes through the eyelid IOP device

BiCOM's device for measuring intraocular pressure (IOP) through the eyelid, the Tonometer Diaton, has received FDA approval.

The device was developed and manufactured by the Ryazan State Instrument-Making Enterprise of the Russian Federation and already has the CE mark. The FDA approval now allows BiCOM to market the Tonometer Diaton in the US.

Diaton tonometry offers clinicians the ability to measure IOP through the eyelid, meaning no anaesthesia or sterilization is required and that no contact with the cornea is made. The hand-held, portable device could be useful for mass prophylactic screening of patients, IOP control during clinical observation of glaucoma patients and as an additional test to diagnose glaucoma. The company also believes that it will prove indispensable for measuring IOP in immobilized patients, children and those with medicinal allergies.

ATG003 goes to trial

Athenagen, a privately held biopharmaceutical company, has initiated a Phase I clinical trial of its topical therapy for age-related macular degeneration (AMD).

ATG003 is a proprietary topical formulation (eye drops) of mecamylamine that has demonstrated efficacy in animal models. The anti-angiogenic agent inhibits endothelial nicotinic acetylcholine receptors and has been shown to decrease angiogenesis and vascular permeability. ATG003 represents a possible alternative to current AMD therapies that require frequent injections directly into the eye.

The study, a randomized, placebo-controlled, ascending dose clinical trial is designed to evaluate ocular tolerability and safety for up to 14 days.

A Phase II efficacy study is expected to follow next year.

FDA trial supports Rayner confidence in Centerflex

The Centerflex foldable, hydrophilic, single-piece intraocular lens (IOL) has demonstrated excellent functional results, according to the results of an FDA trial published in the British Journal of Ophthalmology.

The Rayner Centerflex IOL was implanted into one eye of 83 subjects (mean age 73.5 years) as part of a prospective, non-randomised FDA trial. A standardised FDA protocol, regarding IOL safety and efficacy was followed for three years postoperatively. This included evaluation of spherical equivalent (SE), best corrected distance visual acuity (BCDVA), endothelial cell count, flare metre values, PCO development and anterior capsule shrinkage measurements.