Medicine company Novartis said on Monday that it has filed its Biologics License Application (BLA) for brolucizumab (RTH258) with the US Food and Drug Administration (FDA) for treating wet age-related macular degeneration (AMD), also known as neovascular AMD, or nAMD.

In conjunction with the BLA, the company has used a priority review voucher to expedite the US FDA review of brolucizumab and if approved, the medicine will be introduced in the market by the end of 2019. By 2020, over 1.5m people in the US are likely to have wet AMD, the leading cause of blindness in industrialized countries.

According to the company, Brolucizumab (RTH258) is a humanized single-chain antibody fragment (scFv) to reach this stage of development. Single-chain antibody fragments are highly sought after in drug development due to their small size, enhanced tissue penetration, rapid clearance from systemic circulation and drug delivery characteristics.

The US FDA's regulatory application is based on the company's Phase III data from the HAWK and HARRIER trials,the prospective, randomized, double-masked multi-center studies.

Brolucizumab met the primary endpoint of aflibercept in mean change in best-corrected visual acuity (BCVA) from baseline to week 48 (mean change in BCVA of 6.6 letters for brolucizumab 6mg versus 6.8 letters for aflibercept in HAWK and 6.9 letters versus 7.6 letters, respectively, in HARRIER). HAWK and HARRIER are the first global head-to-head trials in patients with wet AMD that prospectively demonstrated efficacy at week 48 starting with a 12-week dosing regimen, concluded the company.