Intravitreal Injections

So why the different methods?

In 2006, the results of ANCHOR and MARINA (2 large trials looking at effectiveness of Lucentis dosed monthly for AMD) left us surprised by providing visual improvements and stability never before seen. Since then, other trials have followed looking at ways to obtain equal outcomes with fewer injections indeed. Studies repeatedly show that manufacturer recommended monthly therapy results in the best visual outcomes but at the price of more frequent injections. In fact, patients from the original trials who were switched from monthly injections to as needed after 2 years, lost half of their visual gains in the subsequent year, conferring that the best way to maintain vision is to prevent the disease from progressing. Later National Eye Institute sponsored randomized trial called the Comparison Of Age-related Macular Degeneration Treatments Trial (CATT) compared efficacy of Avastin (bevacizumab) to Lucentis (ranibizumab) dosed monthly or as needed. At two years, this study showed that when compared head to head, PRN treatment was inferior to monthly and resulted in poorer visual outcomes. Treat and extend seems like a reasonable compromise between the two treatment regimens.

When we talk about Ranibizumab, by virtue of the fact that this technique extends the interval outside the 4 week therapeutic window of the drug, patients are left unprotected with an increasing risk of recurrence and irrecoverable vision loss, and in fact, Dr Pratik Mahajan has seen patients develop bleeding when patient loses follow up and presents at 5 to 8 weeks!. So while we will sometimes extend patients beyond monthly therapy if they have remained stable for several months, it is important that they understand and accept the potential risks.

Newer molecules Faricimab(Vabysmo), Aflibercept(Eylea) and Brolucizumab(Pagenax) promise a longer duration of action and leading to less frequent dosing and a wonderful visual outcome . Dr Pratik Mahajan at Macretina Hospital Indore follows a evidence-based approach tailored to each and every patient .Not only macular disease , but also cardiovascular and other systemic status is taken care of in the decision making process. So choose what is best for you after a consultation at Macretina Hospital Indore. Following are the common intavitreal injections available at Macretina Hoapital Indore:

1. Vabysmo
2. Eylea
3. Pagenax
4. Accentrix
5. Biosimilars of Ranibizumab (Like Razumab)
6. Ozurdex Intravitreal Implant

1. Vabysmo Over 400,000 patients have been treated worldwide with Vabysmo. VABYSMO is the first and only FDA-approved treatment designed to block 2 causes of vision loss (VEGF and Ang-2).

VABYSMO (faricimab-svoa) is a prescription medicine given by injection into the eye used to treat adults with neovascular (wet) age-related macular degeneration (AMD), diabetic macular edema (DME), and macular edema following retinal vein occlusion (RVO).

https://www.vabysmo.com/dme/how-vabysmo-works.html

2. EYLEA :

Aflibercept 4mg by Bayer is named as Eylea.It is FDA approved in cases of DME, AMD nad RVO. Bayer is also investigating aflibercept 8mg in three pivotal studies, PHOTON, PULSAR and QUASAR.

3. Pagenax:

To address the challenges associated with frequent dosing, a novel humanized single-chain antibody fragment named RTH258, later known as brolucizumab, has been introduced. In the first human trial with this drug, it was found to be non-inferior to ranibizumab and it also offered the advantage of an extended duration of action, reducing the need for frequent injections. Brolucizumab’s small molecular size (26 kDa), high stability, and solubility allow the administration of 6 mg in a single 50 ul intravitreal injection, enabling the delivery of a higher molar dose within the same volume as current vascular endothelial growth factor (VEGF) inhibitors in clinical use, thereby ensuring a longer duration of action. Marketed as Beovu® by Novartis (Basel, Switzerland), brolucizumab received Food and Drug Administration (FDA) approval for nAMD in October 2019 and for DME in June 2022. The Drug Controller General of India granted approval for the drug, which has been available as Pagenax® (Novartis India Ltd, Mumbai, India) since October 2020.

4. Accentrix :

Two pivotal trials determined the effectiveness of Ranibizumab ( Inj Accentrix ): the minimally classic/occult trial of the anti-VEGF antibody ranibizumab in the treatment of neovascular age-related macular degeneration (MARINA) and the anti-VEGF antibody for the treatment of predominantly classic choroidal neovascularization in age-related macular degeneration (ANCHOR). Marina and anchor were the first phase 3 trials to improve visual outcomes for all forms of choroidal neovascularization in Neovascular AMD. Based on this evidence, Ranibizumab was approved by the FDA on June 30, 2006, to treat neovascular amd. Hence it is the most time tested molecule.

5. Biosimilars (Razumab and others):

Biosimilars constitute biological products that demonstrate similar pharmacodynamic and pharmacokinetic characteristics with a reference product, as well as comparable clinical efficacy, safety and immunogenicity. Since the approval of the first biosimilar Razumab, there has been a variety of new biosimilars available on the market. They offer the advantage of the same good clinical and safety results at a better price. All Ranibizumab biosimilars that have gained approval were tested in double masked Phase 3 clinical studies. over the last few years, there is a tendency of using biosimilars in other retinal diseases like retinopathy of prematurity (ROP), diabetic macular edema (DME) or polypoidal choroidal vasculopathy (PCV). In conclusion, ranibizumab biosimilars offer a promising avenue for the management of retinal diseases, especially in cases where there is some financial constraint.

6. OZURDEX

• Ozurdex is a steroid implant prepared by Allergan.Ozurdex has been approved for use in retinal vein occlusions and uveitis. Ozurdex is a tiny corticosteroid implant that slowly releases medication over time, without the need for monthly injections. It  dissolves naturally and need not to be removed
• It is Injected directly into the back of the eye, with minimal systemic absorption

For more information visit www.ozurdex.com.

Before Intravitreal Injection:

Come after a shower and head and face wash in the morning of your appointment. Do have a light breakfast and take normal meals. Do keep your sugar and BP under control and take medicines  (if any ) as prescribed by your family physician. Use of Proparacaine 0.5% eye drops and 30 gauge needle makes injection an essentially painless procedure in the hands of Dr. Pratik Mahajan.

After Intravitreal injection:

Your eye may or may not be patched. Patching provides a soft cotton pad to genltly hug your closed eye to provide comfort. Even it is patched, its only  for an hour or till u travel to your home and remove it yourself. How to take care after intravitreal Injections ? 

Yoy are advised to put antibiotic eye drops as per schedule. Don’t let water go inside your eye for next 3 days. You must follow up as advised. Don’t worry if you feel floaters in your visual field. However if you develop increasing redness, discharge pain or blurring of vision please contact 7771089999. You can contact a nearby ophthalmologist also in case of an emergency.