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BCVA improves after intravitreal integrin treatment for wet AMD
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A new class of therapy that targets integrin rather than VEGF is emerging, one presenter said.
According to OSN Retina Board Member Peter K. Kaiser, MD, ALG-1001 (Allegro Ophthalmic), an oligopeptide that binds to multiple integrin receptor sites associated with neovascular eye diseases, affects multiple angiogenic pathways with long-lasting effects.
At the Association for Research in Vision and Ophthalmology meeting in Seattle, Kaiser delivered interim results of the ongoing Wet AMD Study, a study of monotherapy with ALG-1001 in different doses for patients with active wet age-related macular degeneration. Intravitreal injections of 2 mg or 3.2 mg were given, and patients were followed monthly for at least 4 months with no further treatment.
In seven patients treated with the 3.2 mg dose, interim data showed the mean gain in best corrected visual acuity was 8 letters at 60 days off of treatment, Kaiser said. The improvement in BCVA corresponded to a 30% decrease in central macular thickness and improvement in retinal architecture.
Peter K. Kaiser
“We are seeing a very long duration of effect in many of the wet AMD subjects at the 3.2 mg dose, with many subjects still dry and with stable vision up to 6 months off all treatment after a course of ALG-1001,” Kaiser said in a later interview.
Mechanism of action
“This integrin peptide therapy has a unique mechanism of action that is expected to translate into additional treatment options for both patients and physicians,” Kaiser said.
ALG-1001 binds to the integrins that are associated with neovascular ocular tissue, such as in AMD and proliferative diabetic retinopathy. When ALG-1001 binds to the integrins, it can inhibit endothelial cell proliferation via multiple pathways, Kaiser said, thus stopping production of aberrant blood vessels, reducing leakage and inhibiting growth of blood vessels.
Because the therapy has a different mechanism of action by targeting the integrin rather than VEGF, the therapeutic approach is being considered for stand-alone treatment as well as complementary therapy in conjunction with existing anti-VEGF treatments, according to Kaiser.
“ALG-1001 could be used as monotherapy in any patient with less than ideal vision, despite treatment with current anti-VEGF treatments,” Kaiser said.
Ocular adverse effects
Of the 15 patients in both the groups, five had ocular adverse effects that were mild and injection-related, such as conjunctival hyperemia, trauma at the injection site and +1 cell anterior chamber reaction. One patient received Avastin (bevacizumab, Genentech) rescue at day 150, but no serious adverse events were reported, Kaiser said.
Final data from the 6-month study is expected in the fall, according to Kaiser
“We are excited to see just how long this drug lasts after the loading dose,” he said. “We feel comfortable with at least 3 months of activity after the loading dose. Effects in some patients have lasted much longer off treatment.” – by Cheryl DiPietro