A decade into reformulating Pfizer’s oral renal cell carcinoma drug Inlyta (axitinib) into a treatment that can be injected for a variety of common eye diseases, Clearside Biomedical is making significant strides in its pursuit of Regeneron and Bayer’s Eylea and Roche’s Vabysmo.
Clearside’s CLS-AX (axitinib injectable suspension) has aced a phase 2b trial, achieving its primary and secondary outcomes for patients with neovascular age-related macular degeneration (wet AMD).
In the ODYSSEY study, patients who received CLS-AX maintained stable visual acuity and central subfield thickness for six months compared to participants who were on Eylea. CLS-AX was associated with a positive safety profile, with no ocular or treatment-related serious adverse events.
CLS-AX reduced the injection frequency for patients by 84% over six months, as 67% of patients did not require any added injections before mandatory re-dosing. At four months, 90% of CLS-AX patients did not require additional treatment.
“These data are encouraging and demonstrate that suprachoroidal CLS-AX may have sustained durability beyond our currently approved agents,” David M. Brown, M.D., Director of Research, Retina Consultants Houston, said in the release.
The study enrolled 60 difficult-to-treat patients with active disease who had previously used Eylea. They were randomized 2:1, with 40 patients receiving CLS-AX and 20 continuing on Eylea for 36 weeks.
"These encouraging results strongly support advancing our CLS-AX wet AMD program into phase 3 development and provide further evidence of the potential benefits of delivering medicines to the back of the eye using our proprietary SCS Microinjector,” George Lasezkay, Clearside’s CEO, said in a statement.
Founded a dozen years ago, Clearside bills itself as a company that's “revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space (SCS),” which is the area between the sclera and the choroid and provides a route for minimally invasive medication delivery.
Through a more targeted delivery, this method offers potential advantages over other routes of administration, such as higher drug concentrations, increased bioavailability, and prolonged duration of action. Additionally, this approach minimizes the risk of corticosteroid-related adverse events such as cataracts.
Clearside, which is based in Alpharetta, Georgia, is conducting trials with four potential therapies in five eye disease indications. The goal of Clearside is to provide comparably effective treatments that require fewer office visits for patients.
“We believe the ability to deliver multiple doses as needed between 12 and 36 weeks is a key differentiator from other treatments in development,” Victor Chong, M.D., Clearside’s chief medical officer, said in a statement. “In the trial, we observed that (CLS-AX) can be flexibly dosed similar to current biologic treatments, but has the potential to last longer because it is a highly potent tyrosine kinase inhibitor that achieves pan-VEGF blockade.”