Re Syfovre: ‘It’s a Healthy Debate. It’s a Debate We Should Be Having’ | Charles Wykoff, M.D., Ph.D.

Findings about Synfovre (pegcetacoplan) that are scheduled to be presented at American Society of Retinal Specialists meeting this weekend will be among those most likely to influence clinical practice, says Charles Wykoff, director of clinical research at Retina Consultants of Texas, deputy chair of the Blanton Eye Institute at Houston Methodist Hospital, and chair of the practice management committee of the American Society of Retina Specialist.

In the pivotal phase 3 trial of Syfovre (pegcetacoplan), none of the pre-specified endpointsshowed visual benefit with treatment through the one or two years, according to Wykoff.

“When you say ‘OK, we're improving, we're slowing the progression of the disease, we're slowing the anatomic worsening, but patients aren't seeing better,” it’s sort of a disconnect. And so I'm using this drug A lot of physicians are, but there’s definitely a debate about that. And it's a healthy debate. It's a debate that we shouldn't be having,” Wykoff says.

The meeting also features several presentations about biosimilars for retinal diseases. Currently, there are two on the market, Cimerli (ranibizumab-eqrn) and Byooviz (ranibizumab-runa), which are biosimilars to Lucentis (ranibizumab).

Wykoff says he understands the potential value of the less expensive versions of the brand-name drug, but he says retina specialists are “so comfortable with the drug(s) that we've been using for so long. We know the safety, we know the efficacy, and these drugs (the biosimilars) are relatively new.”

Most retina specialist are looking for more data on biosimilars, Wykoff says, commenting that the approval process for biosimilars is “flipped upside down,” with an emphasis on in vitro and other testing rather than data derived from clinical trials.