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A new drug to treat exudative AMD is approved thanks to a phase III clinical trial conducted at the Institut de la Mácula

24/02/2020 · новости
DMAE-RTH258

Beovu® (Brolucizumab) has received the approval of the European Medicines Agency (EMA) for the treatment of exudative AMD. The Institut de la Màcula took part in one of the clinical trials that led the drug to get the green light, another example of the importance of participating in these studies and of the opportunity to access medicines that are not yet available to the general public

The Institut de la Màcula, in its fight against age-related macular degeneration (AMD), participates in clinical trials continuously. In these studies, patient participation is vital to improve treatments, or to discover new ones. Under the supervision of top experts, participants receive an innovative treatment free of charge.

The HARRIER clinical trial is the most recent example. In 2015, the Institut de la Màcula participated in this trial and the European Medicines Agency (EMA) has now approved the resulting drug, Beovu® (brolucizumab), for the treatment of exudative AMD.

AMD is the leading cause of vision loss in the over-50s in industrialised countries, affecting some 20 million people throughout the world1. In 2006, the emergence of anti-angiogenic drugs for the treatment of AMD began a new era. Now, not only were patients expected not to lose vision but also gains in their visual acuity were observed for the first time. Therefore, the prognosis of the disease2 improved significantly.

Since then, efforts have focused on ensuring that these treatments are more effective and on increasing the interval needed between treatments because one reason for eventual vision loss in patients is their non-compliance with treatment regimes3, 4.

In this regard, last October, brolucizumab received the approval of the U.S. Food and Drug Administration (FDA) for the treatment of exudative AMD. This week, Novartis, the laboratory that markets the drug, announced its approval by the EMA in the 27 States of the European Union plus Iceland, Norway and Liechtenstein.

The drug’s approval has been enabled by the results obtained in the phase III clinical trials, HAWK and HARRIERpromoted by pharmaceutical Novartis. The Institut de la Mácula participated in the latter with the inclusion of patients who took advantage of this treatment before it was approved. Beovu®, the trade name of brolucizumab, has demonstrated visual benefits not inferior to aflibercept (Eylea®) during the two years of study, as well as a better resolution of sub- and intraretinal fluid, a key marker in disease activity.

In addition, more than half of the patients who received treatment with brolucizumab during the study (56% in HAWK and 51% in HARRIER) were able to maintain an injection interval of 3 months after the loading dose without compromising efficacy.

The Institut de la Mácula now has two trials engaged in the process of selecting candidates: TALON, treatment for exudative AMD, and APELLIS for geographic atrophy secondary to AMD.

REFERENCES:

  1. Flaxman SR, Bourne RRA, Resnikoff S, Ackland P, Braithwaite T, Cicinelli M V, et al. Global causes of blindness and distance vision impairment 1990-2020: a systematic review and meta-analysis. Lancet Glob Heal. 2017 Dec 1;5(12):e1221–34.
  2. Rosenfeld, PJ; Brown, DM; Heier, JS; Boyer, DS; Kaiser, PK; Chung, CY; Kim R. Ranibizumab for Neovascular Age-Related Macular Degeneration. N Engl J Med. 2015;373:2103–16.
  3. Heier JS, Brown DM, Chong V, Korobelnik JF, Kaiser PK, Nguyen QD, et al. Intravitreal aflibercept (VEGF trap-eye) in wet age-related macular degeneration. Ophthalmology. 2012;119(12):2537–48.
  4. Silva R, Berta A, Larsen M, Macfadden W, Feller C, Monés J. Treat-and-Extend versus Monthly Regimen in Neovascular Age-Related Macular Degeneration: Results with Ranibizumab from the TREND Study. Ophthalmology. 2018;125(1):57–65.
  5. Dugel PU, Koh A, Ogura Y, Jaffe GJ, Schmidt-Erfurth U, Brown DM, et al. HAWK and HARRIER: Phase 3, Multicenter, Randomized, Double-Masked Trials of Brolucizumab for Neovascular Age-Related Macular Degeneration. Ophthalmology. 2020;127(1):72–84.

Author: Míriam Garcia, Clinical Trials Coordinator and optometrist at the Institut de la Màcula.

Экссудативная или влажная ВМД
Last modified: 25 November, 2020 - 13:28