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Geographic atrophy growth reduced with APL-2 compared with sham

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Geographic atrophy grew at a statistically significantly slower rate after treatment with APL-2, a complement C3 inhibitor from Apellis Pharmaceuticals, than with placebo, according to preliminary 18-month data from the phase 2 FILLY trial presented at the Macula Society meeting.

“The findings from the FILLY study further implicate the complement pathway in the pathogenesis of advanced forms of AMD like GA. APL-2 is unique because it acts on C3, which is the convergence of the complement pathways. Future work in phase 3 will determine what effect decreasing complement will have on patients with GA in a larger study population,” Rishi P. Singh, MD, told Healio.com/OSN.

After 12 months in the trial, patients who received intravitreal APL-2 every month experienced a 29% lower rate of GA lesion growth compared with sham (P = .008), while patients who received APL-2 every other month experienced a 20% lower rate compared with sham (P = .067).

Subjects were followed for an additional 6 months without treatment. During this time the treatment effect of APL-2 declined in the previously treated groups, which then experienced GA lesion growth similar to that of the sham group.

New onset of exudation as a treatment-related ocular adverse event in the study eye was reported in 18 eyes (20.9%) in the monthly group and in seven eyes (8.9%) in the every other month group at the 18-month follow-up. New onset exudation was reported in only one eye in the sham-treated eyes at 18 months.

A phase 3 trial, which will be similar in design to the phase 2 trial, is planned to begin in the second half of the year, according to a press release from Apellis.

In the phase 3 protocol, if exudative AMD develops in the treatment eye, VEGF inhibitors will be administered in addition to continued study treatment, the release said. – by Robert Linnehan

References:

Apellis pharmaceuticals announces 18-month results of phase 2 study (FILLY) of APL-2 in geographic atrophy. http://investors.apellis.com/news-releases/news-release-details/apellis-pharmaceuticals-announces-18-month-results-phase-2-study. Published Feb. 22, 2018.

Singh RP. FILLY. APL-2 (pegcetacoplan) geographic atrophy preliminary 18-month results. Presented at: Macula Society annual meeting; Feb. 21-24, 2018; Beverly Hills, California.

Disclosure: Singh reports he is a consultant for Genentech, Regeneron, Novartis/Alcon, Optos and Zeiss; and receives sponsored research support from Apellis, Genentech, Regeneron, Alcon/Novartis and Clearside.