Anti-VEGF (Vascular Endothelial Growth Factor) drugs administered intravitreally have marked a real revolution in the treatment of many retinal diseases, as they are able to block Neovascular Growth Factor, the biological signal that promotes the growth of abnormal neo-vessels and increased vascular permeability. These mechanisms underlie pathological angiogenesis and macular oedema, two of the main causes of vision loss.
By reducing exudation and neovascularisation, anti-VEGF drugs help stabilise and often even improve visual acuity and OCT-detectable anatomical parameters.
Anti-VEGF drugs for intravitreal use
In Italy, the main anti-VEGFs used in the ophthalmic field are:
- aflibercept,
- ranibizumab,
- brolucizumab
- bevacizumab (the latter used in specific regulatory and therapeutic appropriateness contexts).
Therapeutic indications
The therapeutic indications include age-related macular degeneration in a neovascular/exudative form (so-called 'wet' AMD), diabetic macular oedema (EMD), macular oedema from central or branch retinal vein occlusion (CRVO/BRVO) and certain forms of choroidal neovascularisation, e.g. secondary to pathological myopia (CNV-mp).
In general, the clinical goal is to counteract the progression of the disease over time by preventing irreversible damage to the macula.
Comparative clinical effectiveness
In terms of comparative efficacy, many systematic reviews and meta-analyses indicate a substantial overlap between different anti-VEGFs in terms of visual outcomes, especially in neovascular AMD In some subgroups (e.g. EMD with more impaired baseline visual acuity) some studies have observed short-term advantages for specific pharmacological agents, but these differences are not always maintained in the long term.
Therefore, in clinical practice the choice of drug and treatment regimen tends to integrate clinical evidence, individual response, the need to reduce the 'burden' of injections and sustainability.
Adverse ocular events
From a safety perspective, ocular adverse events related to intravitreal injections may include: endophthalmitis, retinal detachment, increased intraocular pressure. These events are quite rare, but require strict protocols and patient education on warning symptoms.
Serious systemic events (e.g. thromboembolic) are on the whole infrequent, but risk assessment must be personalised, especially in frail patients or those with cardiovascular comorbidities.
Anti-VEGF and quality of life
Anti-VEGFs are currently the first-line therapeutic option for retinal vascular disease, with a generally favourable benefit/risk ratio when used appropriately and safely.
Retinal diseases have a strong impact on the quality of life of patients and their caregivers and, overall, affect almost 80 million people worldwide, representing some of the leading causes of vision loss.
Faricimab: novelty in the treatment of retinal diseases
Faricimab is the first and only bispecific antibody approved for ocular use and characterised by a dual-action mechanism.
Mechanism of action
Faricimab is designed to target and inhibit two signalling pathways linked to various vision-threatening retinal diseases: it acts by neutralising both angiopoietin 2 (Ang-2) and vascular endothelial growth factor A (VEGF-A) to restore vascular stability.
Security Profile
Faricimab is designed for safety and tolerability and clinical studies show that many patients tolerate it well.
Authorisation in Italy
The Italian Medicines Agency (AIFA) has approved, in November 2025, the reimbursability under the National Health Service (NHS) for the new formulation of Faricimab in prefilled syringe (PFS) for use in the treatment of neovascular or 'wet' age-related macular degeneration, diabetic macular oedema (EMD) and for the treatment of visual impairment due to macular oedema secondary to retinal vein occlusion (RVO, branch RVO or central RVO).
Retinal Diseases and Treatment Outcomes
In support of the favourable therapy profile, several studies have confirmed the efficacy and tolerability of faricimab in clinical practice.
Neovascular age-related macular degeneration
Lo FARIT study, the first Italian real-world study on faricimab with a follow-up of at least 12 months, showed encouraging results in terms of efficacy and tolerability in daily clinical practice.
According to data from the FARIT study, the therapy resulted in effective disease control, with longer treatment intervals than previously achieved with other anti-VEGFs. Specifically, about 60% of the naïve patients with neovascular AMD received injections every 4 months (Q16W) already after the loading phase, with only 3 injections in the following 12 months,
These real-world data are further supported by the AVONELLE-X study , the largest long-term extension study in neovascular AMD, which reported visual stability and maintenance of anatomical improvements, with almost 80% of patients being able to extend treatment intervals to 3 or 4 months, confirming maintenance of disease control and treatment duration for over 4 years.
Diabetic macular oedema
In the FARIT study, 100% of naïve patients with diabetic macular oedema (EMD) reached the Q16W interval at 1 year, requiring only 2 injections in the 10 months following the loading phase.
Lo RHONE X studio confirmed at the end of 4 years that, even in EMD, almost 80% of the faricimab-treated participants had prolonged treatment intervals up to three or four months. Furthermore, in a predefined exploratory endpoint, more than 90% of faricimab-treated subjects showed no EMD after 4 years.
Retinal vein occlusion
For patients with retinal venous occlusion (RVO), efficacy and safety data from two international phase III clinical trials, BALATON and COMIN, showed early and lasting improvements in visual acuity and significant reabsorption of retinal fluid, allowing many patients to extend treatment intervals by up to four months.
Advantages of Faricimab
Faricimab's effects can be measured in terms of preventing vascular leakage, cell death and inflammation in ischaemic or reperfusion retinal damage.
In particular, the improvements in visual acuity and results compared to Ranibizumab are remarkable.
Results compared to Ranibizumab
Faricimab stands out in direct comparisons with ranibizumab. Patients treated with Faricimab achieved statistically superior visual gains. This makes it a preferable choice for those seeking maximum benefit.
Future developments in retinal research
Looking to the future, Faricimab paves the way for new research in the retinal field. It could lead to further breakthroughs that will revolutionise the treatment of eye diseases.
- Sahni J, et al. Safety and Efficacy of Different Doses and Regimens of Faricimab vs Ranibizumab in Neovascular Age-Related Macular Degeneration: The AVENUE Phase 2 Randomized Clinical Trial. JAMA Ophthalmol., vol. 138, no. 9, pp. 955-963, Sep. 2020, doi: 10.1001/jamaophthalmol.2020.2685.
- Khanani AM et al. Efficacy of Every Four Monthly and Quarterly Dosing of Faricimab vs Ranibizumab in Neovascular Age-Related Macular Degeneration: The STAIRWAY Phase 2 Randomized Clinical Trial. JAMA Ophthalmol., vol. 138, no. 9, pp. 964-972, Sep. 2020, doi: 10.1001/jamaophthalmol.2020.2699.
- Heier JS et al. Efficacy, durability, and safety of intravitreal faricimab up to every 16 weeks for neovascular age-related macular degeneration (TENAYA and LUCERNE): two randomised, double-masked, phase 3, non-inferiority trials. Lancet, vol. 0, no. 0, Jan. 2022, doi: 10.1016/S0140-6736(22)00010-1.
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