# FDA Approvals of Biologics in 2022
## 4 Therapeutic Indications and Mechanisms of Action
### Eye Disorders  
There have been two important drug advancements for eye disorders in less than three years. In this regard, back in 2019, the single-chain fragment variable (scFv) BeovuTM (brolucizumab), which inhibits three isoforms of VEGF-A, received the green light from the FDA to treat neovascular (Wet) age-related macular degeneration (nAMD) [84]. Two years later, in January 2022, VabysmoTM (faricimb) (Table 6) was also approved for eye disorders such as nAMD and diabetic macular edema (DME). In the context of eye disorders, there is also ranibizumab, which was first approved in 2006 for nAMD, DME, and macular edema following retinal vein occlusion (RVO), and EyleaTM (aflibercept), authorized in 2011 for nMAD. In clinical trials, the main measure of which was a change in Best-Corrected Visual Acuity (BCVA), brolucizumab outperformed aflibercept in minor endpoints and was non-inferior in primary endpoints, and it showed a higher remission of retinal thickness when compared to ranibizumab [85].  
In contrast to brolucizumab, faricimb is a bispecifc humanized antibody [3; 35]. The small size of the immunoglobulin fragments mechanism found in brolucizumab and its drug delivery features are important characteristics for Biologics, and these are also seen  
\begin{table}
\begin{tabular}{c c c c c c} \hline \hline
**Trade Name and** & **Class** & **Target/Mechanism** & **Original** & **Manufacturer** & **Therapeutic** **Indication** \\
**Active Ingredient** & **Class** & **of Action** & **Approval Date** & **Manufacturer** & **Therapeutic** **Indication** \\ \hline VabysmoTM (faricimb) & \multirow{2}{*}{Bispecific mAb} & VEGF-A and & \multirow{2}{*}{28 January 2022} & \multirow{2}{*}{Genentech, Inc.} & \multirow{2}{*}{nAMD and DME} \\
[3; 35] & & Ang-2 & & & \\ \hline \hline \end{tabular} nAMD—Nevovascular (Wet) Age-Related Macular Degeneration; DME—Diabetic Macular Edema; VEGF—Vascular Endothelial Growth Factor; Ang-2—Angiopoitein-2.  
\end{table}
Table 6: Biologic for eye disorders approved by the Food and Drug Administration in 2022.  
\begin{table}
\begin{tabular}{c c c c c c} \hline \hline
**Trade Name and** & **Class** & **Target/Mechanism** & **Original** & **Manufacturer** & **Therapeutic** **Indication** \\ \hline \multirow{4}{*}{\begin{tabular}{c} DaxcifyTM \\ (daxibotulinum- \\ toxin A) [3; 81] \\ \end{tabular} } & \multirow{4}{*}{\begin{tabular}{c} Bothilnum toxin A \\ (protein-based \\ therapy) \\ \end{tabular} } & \multirow{4}{*}{\begin{tabular}{c} Inhibits the \\ release of \\ Acetylcholine \\ to the \\ Neuromuscular \\ Junction \\ \end{tabular} } & \multirow{4}{*}{7 September 2022} & \multirow{4}{*}{\
\begin{tabular}{c} Revance \\ Therapeutics, Inc. \\ \end{tabular} } & \multirow{4}{*}{
\begin{tabular}{c} Improve glabellar \\ lines associated \\ with corrugator \\ and/or procerus \\ and muscle activity \\ muscle activity \\ \end{tabular} } \\ \cline{1-1}  & & & & & \\ \hline \hline \end{tabular}
\end{table}
Table 5: Botulinum Toxin A approved by the Food and Drug Administration in 2022.  
as important characteristics in bispecific mAbs, such as faricimab, whose mechanism is to inhibit two pathways, enhancing the fight against many diseases. Faricimab exerts anti-vascular endothelial growth factor-A (VEGF-A) and anti- angiopoietin-2 (Ang-2) activity [86]. In clinical trials, faricimab demonstrated similar outcomes in the same measure (BCVA) and anatomic improvement when compared to brolucizumab. However, further research is required [87].  
Ongoing Clinical Trials for Faricimab  
Regarding the potential of faricimab to treat other conditions, in this year (2023), a phase 2 trial has begun for faricimab to test non-proliferative diabetic retinopathy, but no results have been posted yet [88]. This year, two phase 3 trials are expected to be completed to test faricimab in macular edema due to hemirentinal vein occlusion, retinal vein occlusion, and central retinal vein occlusion [89; 90]; no results have been posted yet for those studies as well.