Topical wet AMD therapy passes first test with success

April 1, 2007

A Phase I clinical study of Athenagen's topical eye drop therapy for wet age-related macular degeneration (AMD), ATG3, has found it to be safe and well tolerated.

Topical wet AMD therapy passes first test with success

A Phase I clinical study of Athenagen's topical eye drop therapy for wet age-related macular degeneration (AMD), ATG3, has found it to be safe and well tolerated.

The randomized, double-masked, placebo-controlled study enrolled 80 healthy subjects to receive single and multiple dose ascending regimens for up to two weeks. No medication-related systemic side effects were noted and the therapy demonstrated good ocular tolerability.

Success of NicOx glaucoma candidates welcome news for Pfizer

Nitric oxide-donating derivatives of latanoprost for the treatment of glaucoma have been shown to successfully lower intraocular pressure (IOP) in preclinical studies.

The compounds, which are the result of a collaboration between NicOx and Pfizer in 2004, brought about a greater IOP lowering effect than latanoprost in two validated experimental models of raised IOP. In one of these models, a single topical 0.1% dose of latanoprost resulted in an 18% reduction of IOP compared with a 30% reduction achieved with an equimolar dose of the alternative compound.

The two companies have since signed a second agreement granting Pfizer exclusive rights to apply NicOx' proprietary nitric oxide-donating technology across the field of ophthalmology.

B&L initiates voluntary recall

Bausch & Lomb is voluntarily recalling nine production lots of ReNu MultiPlus Multi-Purpose Solution.

The reason for the recall is the discovery of higher than average amounts of trace iron in some bottles, which, over time, will affect the product's stability and colour. Bausch & Lomb is keen to impress that this affects only a small number of stock keeping units and that no other ReNu products are affected.

So far there have been no reports of adverse events relating to the product.

siRNA candidate enters the clinic

SR Pharma has launched a Phase I clinical trial of RTP-801i, a small interfering RNA (siRNA) therapeutic product licensed from Atugen AG, a subsidiary of SR Pharma.

RTP-801i is based on Atugen's proprietary siRNA technology that modifies the expression of one specific gene target involved in the progression of age-related macular degeneration (AMD).

Pfizer, who licensed the product in September of last year, is funding the trial.

Ruboxistaurin delays sight-threatening DME

Daily oral administration of ruboxistaurin (RBX) may delay progression of diabetic macular oedema (DME) to a sight-threatening stage, according to a study published in the March issue of Archives of Ophthalmology.

The PKC-DMES multicentre, double-masked, randomized, placebo-controlled study enrolled 686 patients to receive placebo or RBX orally (4, 16 or 32 mg/day) for 30 months. At baseline, subjects had DME farther than 300 µm from the centre of the macular, an Early Treatment Diabetic Retinopathy Study (ETDRS) severity level of between 20 and 47A and an ETDRS visual acuity (VA) of 75 or more.

The researchers found that the delay in progression was not statistically significant (32 mg RBX versus placebo, p=0.14). However, application of focal/grid photocoagulation prior to progression to sight-threatening DME varied by site and a secondary analysis of progression to sight-threatening DME alone showed that 32 mg of RBX per day reduced progression compared with placebo (p=0.054).

It is thought that, although disease progression was not delayed, daily oral administration of RBX may delay progression to sight-threatening DME.

US launch of Visian TICL delayed