August 11, 2016
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Topical squalamine under study for treatment of occult lesions

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SAN FRANCISCO — The combination of topical squalamine and ranibizumab for treatment of occult lesions less than 10 mm2 in patients with age-related macular degeneration is under study based on trends seen in a subanalysis of the IMPACT study, according to a speaker here.

The IMPACT phase 2 study included 128 patients with wet AMD with both classic and occult lesions randomized to receive topical squalamine (Ohr Pharmaceutical) twice daily or placebo drops twice daily, both in combination with monthly injections of ranibizumab (Genentech).

Peter K. Kaiser, MD , and colleagues undertook the post hoc analysis of patients in the study with occult and classic lesions less than 10 mm2 in area.

“If you take all lesion compositions, but their occult area was less than 10 mm2, they had a similar result as the classic containing lesions. Looking at the mean change of vision for just that classic containing group, a very similar pattern as other combination therapy drugs is shown,” Kaiser said. A similar result was seen also in patients with occult lesions less than 10 mm2.

Based on these findings, a phase 3 clinical study enrolling patients with occult lesions less than 10 mm2 is ongoing, with patients being randomized to receive squalamine eye drops or placebo eye drops with ranibizumab being delivered monthly during the first year of the study, he said. – by Robert Linnehan and Patricia Nale, ELS

Reference:

Kaiser P. Baseline lesion features are predictive of visual response in patients with neovascular AMD treated with topical squalamine and ranibizumab. Presented at: American Society of Retina Specialists annual meeting; Aug. 9-14, 2016; San Francisco.

Disclosure: Kaiser reports he is a consultant for and receives honoraria from Aerpio, Alcon, Allegro, Bayer, Biogen, Chengdu Kanghong, Digisight, InSitu, Novartis, ONL Therapeutics, Ophthotech, Regeneron, Santen, Shire and ThromboGenics; is on the advisory board for Aerpio, Alcon, Allegro, Bayer, Chengdu Kanghong, Digisight, Ohr Pharmaceutical, ONL Therapeutics and Regeneron; receives grants from Novartis and stock options from Allegro and Ophthotech; is a stockholder and has stock with Ohr Pharmaceutical and SKS Ocular LLC; and is the founder and on the board of directors for SKS Ocular LLC and has intellectual property rights with the company.