scholarly journals Future of anti-VEGF: biosimilars and biobetters

Author(s):  
Monika Kapur ◽  
Suvansh Nirula ◽  
Mayuresh P. Naik

AbstractThe advent of Anti- VEGFs like Lucentis (Ranibizumab), Eylea (Aflibercept) and off-label Avastin (Bevacizumab) have radically improved visual outcomes in patients of neovascular Age Related Macular Degeneration (nARMD), Diabetic Macular Edema (DME) and Retinal Vein Occlusion (RVO). It is a matter of great concern that the US patents for Ranibizumab and Aflibercept expired in 2020 with European patents to expire in 2022 and 2025, respectively. With the expiry of these biologics, Biosimilars can prove to be saviours in the posterior segment pharmacotherapy owing to their cost effectiveness and availability of various options. Numerous biosimilars are expected to gain approval for clinical use from the US-FDA and EMA soon. Biobetters are better than the original biologic in one or more parameters but require more research and development resources. With the emergence of better manufacturing and purification processes it is imperative that the biologics and biosimilars become better. The Ophthalmologists need to have in depth knowledge about these Biosimilars and Biobetters before these molecules take over the mainstream market.

2013 ◽  
Vol 16 (3) ◽  
pp. A177
Author(s):  
R. Vitti ◽  
K.M. Clements ◽  
H. Panchmatia ◽  
E. Hulbert ◽  
K. Wittrup-Jensen ◽  
...  

2022 ◽  
Author(s):  
P. Barrett Paulk ◽  
Dala Eloubeidi ◽  
John O. Mason III ◽  
Christine A. Curcio ◽  
Jason N. Crosson ◽  
...  

Abstract Background Patients presenting with macula-off rhegmatogenous retinal detachment (RRD) with concomitant age-related macular degeneration (AMD) and their treating physicians would benefit from knowledge regarding the visual prognosis after repair. The prognosis for such patients is not well known. The purpose of this study is to compare visual outcomes in macula-off RRD in eyes with AMD versus a group of comparison eyes without AMD. Methods This was a retrospective chart review of 1,149 patients. A total of 191 eyes met study criteria, 162 non-AMD eyes (controls) and 29 AMD eyes. The main outcome measure was postoperative visual acuity in control eyes versus AMD eyes, and this was compared using Fisher’s exact test. Results There was a statistically significant difference in postoperative visual acuity by AMD status, with those without AMD having a higher frequency of Count Fingers (CF), Hand Motion (HM), Light Perception (LP), or No Light Perception (NLP) vision (p = 0.023). More specifically 5.56% of non-AMD eyes and 3.45% of AMD eyes were 20/40 or better, 77.16% of non-AMD and 55.17% of AMD eyes were worse than 20/40 and better than 20/200, 10.49% of non-AMD eyes and 37.93% of AMD eyes were 20/200 or worse, and there were 11 eyes in the non-AMD group with CF, HM, LP, or NLP vision while there was only 1 eye in the AMD group with CF vision. Conclusions Though postoperative visual acuity was worse in the non-AMD group with a higher frequency of patients having final vision of CF, HM, LP, or NLP, this is not likely a clinically significant finding. Rather, it is a function of the difference in sample size and composition between the two groups. Importantly, this study suggests AMD patients can expect similar outcomes to non-AMD patients after RRD repair. Our study suggests that approximately 58% of patients with AMD can expect to maintain functional vision better than 20/200. We conclude that AMD patients can achieve functional vision after RRD surgery, similar to those without AMD. These findings may be helpful in guiding realistic expectations of AMD patients with RRD.


Author(s):  
Tayo Julius Bogunjoko ◽  
Adekunle O. Hassan ◽  
Adunola Ogunro ◽  
Toyin Akanbi ◽  
Bidemi Abudu

Background: To review cases of posterior segment eye diseases (PSEDs) seen at the Eye Foundation Centre Ijebu, Nigeria in a 5 year period for planning purposes.Methods: Data was collected from patients’ case notes from January 2006 to December 2011. A systematic sampling of 468 patients from 1173 case notes of patient with (PSEDs) was done. Information retrieved was: age, sex, state of residence and diagnosis. All patients were examined by the glaucoma and the vitroretinal specialist as the case may be. They had visual acuity, refraction, slit lamp examination (including intraocular pressure (IOP) with Goldman applanation tonometer), and dilated fundoscopy with (bilateral indirect ophthalmoscopy) BIO, slit lamp using 20 D, 78 D and 90 D respectively. The glaucoma patients in addition had central visual field (CVF), Central cornea thickness (CCT), fundus photograph and in some cases optical coherence tomography (OCT) done in addition to the above.Results: The mean age was 59.98 years (SD 17.67) and the age range is 5-95 years. Males outnumbered females by 63% to 37%. The diseases were more common in age group 61 to 80. Patients’ attendances were mostly from Ijebu division of Ogun state (57%). Glaucoma is the commonest cause of attendance 262 (56%) followed by diabetic retinopathy 29 (6.2%) and age-related macular degeneration (ARMD) 28 (6.0%).Conclusions: Glaucoma, diabetic retinopathy and ARMD were noted as the commonest PSEDs in Ijebu division in Southwestern Nigeria.


2018 ◽  
Vol 1 (1) ◽  
pp. 62-70
Author(s):  
Juhn AT ◽  
Shyu AP ◽  
Benjamin J ◽  
Zhang Y

Subthreshold Diode Micropulse (SDM) laser is a relatively new treatment modality that confers very little to no anatomical risk to the retina. However, its efficacy is still being studied, and the scenario where SDM is most useful is still being elucidated. This paper reviews articles from 1997 to 2017 and reviews the settings, results, and outcomes of SDM in various clinical settings including diabetic macular edema, branch retinal vein occlusion, central serous Chorioretinopathy, proliferative diabetic retinopathy, and age-related macular degeneration.


2013 ◽  
Vol 06 (02) ◽  
pp. 144 ◽  
Author(s):  
William G Christen ◽  
Emily Y Chew ◽  
◽  

Recent findings from observational epidemiologic studies have raised concern about a possible adverse effect of regular aspirin use in age-related macular degeneration (AMD), and in particular neovascular AMD, which is the leading cause of severe irreversible blindness in the US. In this report, we consider these findings in light of the relative strengths and limitations of observational studies and randomized trials. While the findings are important and warrant further investigation, the inherent limitations of observation studies, most notably uncontrolled confounding, preclude an interpretation of causality. Alternatively, the most reliable evidence with which to evaluate the effects of regular aspirin use in AMD will derive from well-designed randomized trials of sufficient size and duration.


Author(s):  
Ahmad Mirshahi ◽  
Alireza Lashay ◽  
Hamid Riazi-Esfahani ◽  
Nazanin Ebrahimiadib ◽  
Hassan Khojasteh ◽  
...  

Purpose: To report the results of intravitreal injection of a bevacizumab biosimilar called Stivant®. Methods: This prospective interventional case series was conducted on eyes with neovascular age-related macular degeneration (nAMD), retinal vein occlusion (RVO), and diabetic macular edema (DME). Stivant® was injected in three consecutive months and changes in best-corrected visual acuity (BCVA) and central macular thickness (CMT) were measured at baseline and monthly up to one month after the third injection. Results: Three hundred and eighty-five eyes with DME (234 eyes, 61%), nAMD (87 eyes, 22%), and macular edema secondary to RVO (64 eyes, 17%) were enrolled. The mean ± standard deviation age of the patients was 61.7 ± 7.20 years. The mean BCVA and CMT changed from 0.63 ± 0.3 to 0.51 ± 0.3 LogMAR (P = 0.12 ) and from 420.4 ± 47.3μm at baseline to 316.7 ± 50.6 μm (P < 0.001) in the DME group; from 0.79 ± 0.3 to 0.68 ± 0.3 LogMAR (P = 0.19) and from 376.1 ± 31.7 μm to 303 ± 31.3 μm (P = 0.019) in the nAMD group; and from 0.81 ± 0.4 to 0.63 ± 0.4 LogMAR (P = 0.05) and from 424.21 ± 18 μm to 303.4 ± 18.8 μm (P < 0.001) in the RVO group, respectively. Conclusion: Our limited experience showed that the intravitreal injection of Stivant® was well tolerated. Although the results of this case series showed relative improvement in CMT one month after the last injection of Stivant®, BCVA improvement was statistically significant only in the RVO group. This would be essential to design a randomized clinical trial to evaluate the non-inferiority of Stivant® in comparison to bevacizumab.


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