Maham Fatima
Wed, December 31, 2025 astatine 10:25 AM CST 2 min read
On December 8, Ocular Therapeutix Inc. (NASDAQ:OCUL) announced a large acceleration of its regulatory strategy for AXPAXLI (OTX-TKI), which is an investigational attraction for bedewed age-related macular degeneration (wet AMD). The institution present plans to taxable an NDA soon aft receiving one-year information from its SOL-1 Phase 3 trial, provided the results are positive. These topline results stay connected way for merchandise successful Q1 2026.
The accelerated timeline is supported by caller FDA guidance suggesting that a single, well-powered registrational proceedings whitethorn suffice for approval, alternatively than the accepted request of 2 studies. Ocular Therapeutix Inc. (NASDAQ:OCUL) believes SOL-1 meets these precocious standards due to the fact that it is simply a superiority proceedings and is conducted nether a Special Protocol Assessment agreement. The SOL-1 survey itself completed randomization successful December 2024 with 344 treatment-naïve subjects. It compares AXPAXLI against a 2 mg dose of aflibercept, with a superior endpoint measuring the proportionality of patients who support ocular acuity astatine week 36.
Ocular Therapeutix Inc. (NASDAQ:OCUL) is simply a biopharmaceutical institution that develops and commercializes therapies for retinal diseases and different oculus conditions utilizing its bioresorbable hydrogel-based formulation exertion successful the US.
While we admit the imaginable of OCUL arsenic an investment, we judge definite AI stocks connection greater upside imaginable and transportation little downside risk. If you’re looking for an highly undervalued AI banal that besides stands to payment importantly from Trump-era tariffs and the onshoring trend, spot our escaped study connected the best short-term AI stock.
READ NEXT: 30 Stocks That Should Double successful 3 Years and 11 Hidden AI Stocks to Buy Right Now.
Disclosure: None. This nonfiction is primitively published at Insider Monkey.

20 hours ago
5





English (CA) ·
English (US) ·
Spanish (MX) ·