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Visual gains achieved with abicipar for diabetic macular edema
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CHICAGO — A cohort of patients with diabetic macular edema receiving abicipar pegol every 8 weeks showed “comparable” gains in visual acuity when compared with every 4-week dosing with ranibizumab, according to a presenter here.
Tarek S. Hassan, MD, reported results of the PALM study at Retina Subspecialty Day preceding the American Academy of Ophthalmology meeting. In the multicenter, double masked, phase 2 trial supported by Allergan, 43 patients received 1 mg abicipar every 8 weeks, 41 patients received 2 mg abicipar every 8 weeks, 45 patients received 2 mg abicipar every 12 weeks, and 20 patients received 0.5 mg ranibizumab every 4 weeks. The primary endpoint of the trial was the mean change from baseline of ETDRS baseline corrected visual acuity, Hassan said.
Tarek Hassan
Efficacy was demonstrated in all cohorts, with abicipar 2 mg cohorts showing functional and anatomical effects comparable to the monthly ranibizumab cohort, Hassan said.
At the primary endpoint of week 28, patients in the ranibizumab cohort gained an average of 9.6 letters, Hassan said.
“The [1 mg every 8 weeks] abicipar group clearly appeared under-dosed, with a final endpoint visual acuity improvement of roughly 4.9 letters at week 28,” Hassan said. “When we increased the dose to the [2 mg every 8 week] level, we saw visual results improved significantly and this was also shown with the [2 mg every 12 weeks],” Hassan said.
Patients in the 2 mg every 8-week group gained 7.1 letters, and patients in the 2 mg every 12-week group gained 7.2 letters at 28 weeks. – by Robert Linnehan
Reference:
Hassan TS. A multicenter, double masked phase 2 clinical trial evaluating abicipar pegol for diabetic macular edema. Presented at: American Academy of Ophthalmology annual meeting; Oct. 14-18, 2016; Chicago.
Disclosure: Hassan reports he is a consultant for Alcon, Allergan, ArcticDx, Bayer Healthcare Pharmaceuticals, Genentech, Hoffman La Roche., Insight Instruments, Novartis, Ocugenix and Regeneron. Hassan reports he is an equity owner of ArcticDx and holds patents/royalties with Insight Instruments.