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Squalamine maintained or improved vision in phase 2 trial
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PLYMOUTH MEETING, Pa. — A phase 2 study of squalamine for the treatment of choroidal neovascularization associated with age-related macular degeneration showed all patients receiving a 40 mg dose had preserved or improved vision through month 4 of follow-up, according to a press release from Genaera, the drug’s developer. Study results were presented at the Macula Society meeting.
Preliminary pharmacokinetics results from six patients treated with 40 mg of Evizon (squalamine, Genaera) weekly for 4 weeks suggested that the drug undergoes biphasic elimination from circulation with a terminal half-life of about 7 hours. The greatest degree of improvement at 4 months was a gain relative to baseline of 18 letters, while the greatest degree of loss was 12 letters, according to the press release.
In preliminary results in six patients with bilateral disease treated with 10 mg of Evizon, 10 eyes had preserved or improved vision at 4 months after initiation of therapy.
Roy C. Levitt, MD, president and chief executive officer of Genaera, said results from this trial will help establish the lowest effective dose for upcoming phase 3 trials.
Squalamine is a synthetic small molecule administered systemically that directly interrupts and reverses multiple facets of the angiogenic process. In a separate press release, Genaera announced that Evizon is the new brand name of the drug.