The FDA’s clearance of the investigational new drug (IND) application to advance NOV05 in a phase 2 clinical trial for noninfectious anterior uveitis (NIAU) represents a meaningful advance in the uveitis treatment landscape.
Currently, corticosteroids remain the gold standard for the treatment of NIAU, but these therapies have well-recognized complications including cataract and elevated IOP. In patients with chronic disease or in whom corticosteroid-related adverse effects need to be avoided, systemic steroid-sparing immunosuppression is often employed, but its use may be limited by systemic tolerability. NOV05 is a corticosteroid-free topical tacrolimus formulation that aims to deliver effective anti-inflammatory therapy to eyes with NIAU, potentially mitigating the risks associated with topical, periocular or intraocular corticosteroids or systemic immunosuppression.
Effective well-tolerated corticosteroid-sparing therapies for anterior uveitis remain an important unmet need, and this IND clearance establishes a critical step toward expanding locally delivered treatment options for ophthalmologists.
Jordan D. Deaner, MD
Mid Atlantic Retina
Retina Service, Wills Eye Hospital
Assistant professor of ophthalmology, Sidney Kimmel Medical College at Thomas Jefferson University
Disclosures: Deaner reports consulting for AbbVie, ANI Pharmaceuticals, Bausch + Lomb, EyePoint Pharmaceuticals, Genentech and Regeneron and speaking for ANI Pharmaceuticals and Bausch + Lomb.
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