BofA Bullish on Ocular Therapeutix (OCUL) as AXPAXLI Targets Superiority Label and Faster Regulatory Path in Wet AMD

Ocular Therapeutix Inc. (NASDAQ:OCUL) is one of the low priced stocks to buy with high upside potential. On December 12, Bank of America raised the firm’s price target on Ocular Therapeutix to $21 from $18 and maintained a Buy rating on the shares. After hosting CEO Pravin Dugel to review upcoming corporate milestones, the firm highlighted the development strategy for AXPAXLI, supported by pivotal trials in both wet AMD and diabetic retinopathy. BofA remains optimistic about the drug’s unique competitive advantages and the possibility of a faster regulatory path.

On December 8, Ocular Therapeutix Inc. (NASDAQ:OCUL) announced a major acceleration of its regulatory strategy for AXPAXLI (OTX-TKI), which is an investigational treatment for wet age-related macular degeneration (wet AMD). The company now plans to submit an NDA shortly after receiving one-year data from its SOL-1 Phase 3 trial, provided the results are positive. These topline results remain on track for release in Q1 2026.

The accelerated timeline is supported by recent FDA guidance suggesting that a single, well-powered registrational trial may suffice for approval, rather than the traditional requirement of two studies. Ocular Therapeutix Inc. (NASDAQ:OCUL) believes SOL-1 meets these high standards because it is a superiority trial and is conducted under a Special Protocol Assessment agreement. The SOL-1 study itself completed randomization in December 2024 with 344 treatment-naïve subjects. It compares AXPAXLI against a 2 mg dose of aflibercept, with a primary endpoint measuring the proportion of patients who maintain visual acuity at week 36.

Ocular Therapeutix Inc. (NASDAQ:OCUL) is a biopharmaceutical company that develops and commercializes therapies for retinal diseases and other eye conditions using its bioresorbable hydrogel-based formulation technology in the US.

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Disclosure: None. This article is originally published at Insider Monkey.