Ocular Therapeutix received a written response from the FDA that the Phase 3 SOL-R clinical trial is appropriate for use as the company’s second adequate and well-controlled study of AXPAXLI (axitinib intravitreal implant, also known as OTX-TKI) for the treatment of patients with wet AMD.

In a Type C written response, the FDA agreed 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 FDA also noted that the use of one superiority study and one non-inferiority study is generally acceptable as the basis of an eventual NDA in wet AMD. Together, the company said that it intends the ongoing SOL-1 and SOL-R Phase 3 clinical trials to form the basis for the regulatory filing of AXPAXLI for wet AMD, assuming successful completion.

In addition, the first subjects have been enrolled in the SOL-R non-inferiority study evaluating repeat dosing of AXPAXLI, the company said. Enrollment in the SOL-1 superiority study evaluating a single AXPAXLI implant continues to accelerate, with subjects who do not meet randomization criteria having an opportunity to be enrolled into SOL-R, the company said.

SOL-1 is a superiority study comparing a single AXPAXLI implant to a single aflibercept (2 mg) injection, after both arms receive two aflibercept (2 mg) loading doses. SOL-R compares AXPAXLI dosed every 6 months to the current standard of care, aflibercept (2 mg) dosed every 8 weeks. A third arm evaluating 8 mg aflibercept dosed every 6 months 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, the company said.