The clinical trial results, including pharmacokinetic data and updated visual acuity outcomes, came from a multi-center open-label US phase II clinical trial with Evizon (squalamine lactate) for the treatment of choroidal neovascularization associated with age-related macular degeneration (AMD), also known as ‘wet’ AMD.
Preliminary pharmacokinetics results from six patients treated with 40mg of Evizon weekly for four weeks suggest that Evizon undergoes biphasic elimination from the circulation with a terminal half-life of about seven hours, and no change in kinetics or drug accumulation was observed through week five.
All patients receiving the 40mg dose were diagnosed with wet AMD in both eyes including early and advanced lesions. All of these patients had preserved or improved vision during evaluation in both affected eyes through month four.
Preliminary results from six patients treated with 10mg of Evizon, each diagnosed with bilateral wet AMD, demonstrated that 90% of eyes had preserved or improved vision during evaluation at four months after initiation of therapy.
The drug was also well tolerated, with no drug-related serious adverse events occurring.
“These results are particularly important because we were able to treat both affected eyes in all patients with 40mg of Evizon regardless of the stage of the lesion, conveniently and safely,” said Dr Roy Levitt, president and CEO of Genaera Corporation.
“Thus, in these patients with both eyes affected, less invasive Evizon avoids the risk of bilateral ocular injections required with the administration of other approved or investigational anti-angiogenic agents.”