FDA issues Type C written response for SOL-R wet AMD study
The SOL-R clinical trial of is deemed appropriate for use as Ocular Therapeutix’s second adequate and well controlled study of axitinib intravitreal implant.
(Image credit: AdobeStock/monticellllo)
Ocular Therapeutix, Inc. received a written response from the U.S. Food and Drug Administration (FDA) stating that the Phase 3 SOL-R clinical trial (NCT06495918) is appropriate for use as the company’s second adequate and well controlled study of axitinib intravitreal implant. This implant is also known as OTX-TKI or AXPAXLI and is being evaluated for the treatment of patients with wet age-related macular degeneration (wet AMD).1
According to the company’s press release, the FDA agreed in a Type C written response, that the SOL-R repeat dosing wet AMD study is appropriate as an adequate and well-controlled study in support of a potential New Drug Application (NDA) and product label. The association also noted that the use of 1 superiority study and 1 non-inferiority study is generally acceptable as the basis of an eventual NDA in wet AMD.1
Ocular Therapeutix intends to use the ongoing SOL-1 (NCT06223958) and SOL-R Phase 3 clinical trials to form the basis for the regulatory filing of AXPAXLI for wet AMD, assuming successful completion.
The first participants have been enrolled in the SOL-R non-inferiority study evaluating repeat dosing of AXPAXLI. Enrollment in the SOL-1 superiority study evaluating a single AXPAXLI implant continues to accelerate. Patients who do not meet randomization criteria for SOL-1 have an opportunity to be enrolled into SOL-R.1
In the company’s press release1, Pravin U. Dugel, MD, Executive Chairman, President and Chief Executive Officer of Ocular Therapeutix shared insights on this milestone, saying, “We are very pleased that the FDA has found the SOL-R repeat dosing study to be acceptable as a registrational trial of AXPAXLI in wet AMD. This is an outstanding achievement for Ocular that clarifies the regulatory path for the two complementary Phase 3 studies in the AXPAXLI wet AMD program, SOL-1 and SOL-R. Our Phase 3 program is designed to align with the FDA’s guidance and provide commercially meaningful data. Thanks to the efforts of our clinical team, we have accelerated enrollment in our first study, SOL-1. In addition, over a period of less than 3 months, the team was able to conceptualize SOL-R, activate clinical sites, enroll the first subjects, and has now obtained confirmatory FDA feedback regarding the registrational study. We look forward to continuing our collaboration with regulatory authorities as we work towards our goal of making AXPAXLI available to people with wet AMD.”
Similarly, Carl C. Awh, MD, FASRS, a Past-President of the ASRS and President of Tennessee Retina, a member of the Retina Consultants of America network, also shared how these trials may impact the future of this candidate and wet AMD treatment. In the press release1, he is quoted as saying, “Patients with wet AMD need new therapeutics that can provide long-term improvements in visual outcomes through durable and sustained suppression of VEGF. The initiation of the Phase 3 AXPAXLI program is great news for the retina community because it potentially brings us one step closer to having a new treatment paradigm for patients with wet AMD. In addition, the AXPAXLI program provides an opportunity to be part of innovative study protocols that have been accepted for registration-enabling studies by the FDA. Now that both SOL-1 and SOL-R are open for enrollment, people with wet AMD have 2 opportunities to participate in a clinical study for AXPAXLI. When I talk with my patients, they find it comforting to know that everyone who is randomized into each study is guaranteed to receive an active agent. Patients who are not eligible to be enrolled in SOL-1 are also enthusiastic to participate in SOL-R because of the ‘real-world’ repeat dosing element. I also feel the introduction of a third arm to ensure adequate masking, without the use of sham injections, enhances the integrity of the SOL-R study. I am glad to be part of two studies that have the potential to provide the retina community with important data on efficacy, durability of response, and dosing flexibility of AXPAXLI, and improve the care of people with wet AMD.”
The format of the SOL-1 clinical trial is that of a superiority study comparing a single AXPAXLI implant to a single aflibercept (2 mg) injection, after both arms receive 2 aflibercept (2 mg) loading doses. In the SOL-R trial, there is a comparison of AXPAXLI dosed every 6 months (Q6M) to the current standard of care, aflibercept (2 mg) dosed every 8 weeks. A third arm evaluating 8 mg aflibercept dosed Q6M is incorporated in the SOL-R study to ensure adequate masking, following the FDA’s recommendation that sham injections do not provide complete masking and therefore may elicit potential bias.1
