Squalamine's data is pretty good.
Patients receiving squalamine were also more than twice as likely to gain =4 and =5 lines of vision compared with placebo patients (=4 lines p=0.022, =5 lines p=0.059). It is important to note
that VA gains with placebo plus Lucentis PRN were consistent with those previously observed in other Lucentis monotherapy trials. Squalamine was well tolerated, with a comparable safety profile to placebo. We believe that squalamine's ability to improve VA in back of the eye disease may be due to its inhibition of
multiple angiogenic growth factors.
at least as good at opthotech's data
The VA results achieved with squalamine would at first glance appear comparable to the Phase 2b results with Fovista, but are actually better, in our view. In a Phase 2b trial with Fovista, patients receiving Fovista plus Lucentis gained 10.6
letters at week 24, versus 6.5 letters for patients taking placebo plus Lucentis (p=0.019), representing a 62% additional benefit. However, we note that the Lucentis control arm in the squalamine Phase 2 trial performed as expected, whereas the control arm in the Fovista Phase 2 trial underperformed historical
Lucentis monotherapy. By contrast to the Phase 2b Fovista trial, we note that the Ohr trial needed less than monthly Lucentis injections (2/3 fewer shots than Fovista/Lucentis dual therapy) to achieve the VA gains seen with Fovista combination therapy. The Fovista trial also enrolled only patients with classic lesions, whereas the squalamine trial enrolled a broader, more representative range of patients. With Fovista, a patient must receive an anti-VEGF injection, go back to the waiting room for at least 30 minutes, and then can receive Fovista, due to the intraocular pressure risk of injecting too much fluid from 2 injections into the eye over a shorter time period
