CTS 2026: OTX-TKI demonstrates superiority over aflibercept in wet AMD—what the SOL-1 data mean for retina practice

Mark Barakat, MD, vitreoretinal surgeon and director of research at the Retina Macula Institute of Arizona, spoke with Modern Retina following the 2026 Clinical Trials at the Summit (CTS), held June 12–13 at the Fontainebleau Hotel in Las Vegas, Nevada. Barakat, who served as an investigator in the SOL-1 (NCT06223958) trial, presented efficacy outcomes data at the meeting and discussed what the results mean for both clinical trial design and real-world retina practice.

Barakat opened by highlighting what makes CTS uniquely valuable in the drug development landscape. "CTS is one of my favorite meetings," he noted, citing not only the formal program but the multidisciplinary hallway conversations among logistics coordinators, reading centers, AI developers, regulatory experts, sponsors, pharmaceutical representatives, and investors. He identified two areas of the expanded 2026 agenda as particularly important: regulatory strategy—specifically, whether a single, well-controlled superiority trial could support FDA approval under special protocol assessment—and artificial intelligence, which he described as transformative for subject identification, screen failure reduction, and overall trial efficiency.

What makes SOL-1 different?

Turning to the SOL-1 results, Barakat explained the trial design and its regulatory significance:

• Patients with treatment-naive neovascular age-related macular degeneration (AMD) were randomized 1:1 to OTX-TKI versus 2 mg aflibercept following a two-monthly run-in period
• Patients were required to have strong baseline vision—approximately 20/20 or an ETDRS letter score near 80—at the time of randomization
• The primary endpoint was rescue-free survival at week 36, defined as avoiding a 15-letter loss of vision
• At the primary endpoint, approximately 75% of eyes in the OTX-TKI arm remained rescue-free
• Time to a 30-micron anatomic shift was approximately 23 weeks longer in the OTX-TKI arm compared with aflibercept
• Time to first rescue treatment was approximately 24 weeks longer—roughly six months—in the OTX-TKI arm

On the safety profile, Barakat acknowledged that mild to moderate inflammation was observed in some patients but noted that cases resolved with topical therapy, and in some instances without treatment. He confirmed there were no cases of occlusive vasculitis. Floaters were reported, as expected with a dissolving hydrogel implant, but Barakat expressed confidence that the delivery technology ensures complete resolution: "I have confidence that those floaters based on the delivery technology will disappear, so I'm not worried about that." He added that frequent intravitreal bolus injections with conventional agents may paradoxically introduce more persistent floaters than the implant itself.

Looking ahead: the next five years

Looking ahead, Barakat offered a compelling vision for the next five years. He envisions a treatment paradigm in which OTX-TKI is layered onto existing anti-VEGF therapy, providing an extended margin of safety that reduces the urgency of frequent injection visits. Home OCT monitoring, he suggested, could allow patients to track fluid fluctuations remotely, with in-office visits for imaging and injection becoming less frequent—potentially every three to six months. He also noted that the superiority data may provide a pathway around step therapy restrictions, allowing clinicians to approach payers with evidence that OTX-TKI falls outside standard step-therapy protocols. Longer term, Barakat sees gene therapy as a logical next addition to this layered treatment model.