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SPOTLIGHTS
SAVE your Sight – New Treatment for PCV Patients

If you are seeing distorted straight lines or in other words, wavy lines, it might be an alarming sign that you have an age-related eye disease – PCV (Polypoidal Choroidal Vasculopathy).

What is PCV?

PCV is a common subtype of a wet Age-related Macular Degeneration (AMD) and is a leading cause of blindness globally. It is characterised by the abnormal growth of blood vessels ending in polyps forming at the back of the eye [1], causing sudden and dramatic vision loss.

Due to the aging population, it is estimated that there will be a significant increase to 17 million people in Asia Pacific who will be affected by wet AMD in 2040, as compared to 7 million in 2010 [2]. In the early stages of the disease, PCV patients experience distortion in their vision. They eventually see dark spots in their central vision as the disease progresses into its advanced stages.

The big patch of vision loss in the centre of their field of vision will stay with them wherever they look, regardless of what they see – be it people’s faces or objects. They can’t see, read, or write properly, can’t recognise the faces that they talk to, can’t tell the time, and most importantly, have difficulty carrying out important everyday tasks such as driving. This significantly affects their quality of life. Imagine having to do your daily tasks with partial vision loss! A study showed that PCV patients are 17 times more likely to need help with self-care, home care, and administrative tasks in their daily life. [3]

The risk of a PCV patient falling is twice as high as the average person [4], due to the distorted vision and inherent dangers associated with it. As this disease has huge impact in their social life and leisure activities, 1 in 3 of the patients end up suffering clinical depression, even when only one eye is affected [5,6].

Are you at Risk of PCV?

A study conducted by Honda S. et al showed that PCV is prevalent among the Asian population. PCV accounts for 23-55% of patients with wet AMD in the Japanese population, 49% in the Taiwanese, and 22-25% in the Korean and Chinese populations [7]. This disease is more common among Asian males [8-10] than in females but the reason is yet to be known.

PCV also tends to be more prevalent among people aged 50-65. [11] The risk of getting PCV increases with age. Family history [7,12,13] and lifestyle factors such as smoking, also increase the chance of getting wet AMD or PCV [14]. Additionally, there are uncertain risk factors leading to PCV such as hypertension, coronary artery disease, and diabetes [15,16].

New data on the effectiveness of Aflibercept monotherapy from a one-year PLANET study

Bayer Pharmaceuticals announced new data from the PLANET study at the PLANET Asia Pacific Press Conference held in Bangkok on 9th December 2016, indicating that Aflibercept is effective as monotherapy for PCV patients, thereby raising the hopes of phasing out photodynamic therapy (PDT) for this disease in the near future.

Present at the press conference was Professor Gemmy Cheung, Senior Consultant Ophthalmologist at the Singapore National Eye Centre and a clinician investigator at the Singapore Eye Research Institute. She shared information about PCV and the existing gaps in disease management.

Vascular Endothelial Growth Factor (VEGF) is a type of protein that triggers formation of new blood vessels (angiogenesis) to support the growth of the body’s tissues and organs under normal conditions. “Wet AMD occurs due to an excess of VEGF protein. An excess of VEGF will cause abnormal blood vessels to grow, forming polyps at the back of the eye. These new blood vessels have thin, fragile membranes that leak blood, lipids and fluids, thus, causing the macula to swell. If left untreated, this swelling will result in scarring and damage to the retina, leading to irreversible vision loss. This condition is very important and we need a strong and fast treatment for PCV patients,” said Professor Gemmy Chung.

Also in attendance was Professor Won Ki Lee, Chief of Vitreo-retinal division of the Department of Ophthalmology at Seoul St. Mary’s Hospital. Professor Lee showed the results from the PLANET study which lasted for 52 weeks, and reported that Aflibercept monotherapy leads to favourable vision gains and high rates of polyp inactivation.

PLANET is a Phase IIIb/IV, randomized trial carried out at 62 study sites, involving a total of 333 male and female patients aged 50 and above. The 52-week study demonstrated that Aflibercept can be established as a first-line treatment option for patients with visual impairment due to PCV. Patients receiving Aflibercept could have improved visual acuity without the need for initial PDT.

The results of the study were first presented at the 10th Congress of the Asia-Pacific Vitreo-Retina Society (APVRS) 2016. The PLANET will continue until week 96, where it is estimated to be in September 2017. This second year of PLANET will assess the efficacy of Aflibercept Treat-and-Extend in PCV, and potentially lead to extended treatment intervals and a reduced number of injections.

More about Aflibercept

Aflibercept solution used in an eye injection is a recombinant fusion protein. It consists portions of human VEGF receptors 1 and 2 domains that fused to the Fc portion of human IgG1, to block key triggers (VEGF-A, VEGF-B and PlGF) involved in the growth of new abnormal blood vessels in the eye. It is formulated as an iso-osmotic solution for intravitreal administration.

As an anti-VEGF treatment comprising a specifically designed human protein with two ‘arms’, the Aflibercept solution is injected into the affected eye. Its functions are blocking the growth of new blood vessels in the eye, reducing swelling and leakage, and shrinking the abnormal blood vessels and polyps.

With the new data from PLANET, it is now proven that patients can benefit from the effective Aflibercept monotherapy without the associated side effects of PDT treatment and spend lesser time in treatment too. The treatment is advised to be administered every month for 3 months, followed by once every 2 months.

Bayer AG and Regeneron Pharmaceuticals, Inc. are collaborating closely on the global development of Aflibercept. Regeneron has exclusive marketing rights for Aflibercept in the U.S.A. Bayer AG has licensed the exclusive marketing rights to outside the U.S.A, where the companies share the profits from sales of Aflibercept equally, except for Japan where Regeneron receives a percentage on net sales.

References:

  1. Liu K, Lai TY, Ma L et al. Ethnic differences in the association of SERPING1 with age-related macular degeneration and polypoidal choroidal vasculopathy. Sci Rep 2015; 5: 9424.
  2. Region Asia/Pacific AMD Epidemiology, Tessellon Inc., Latest Update: 2012 /DME Epidemiology, Tessellon Inc., Latest Update: 2014.
  3. Soubrane, G. et al. Burden and health care resource utilization in neovascular age-related macular degeneration: findings of a multi country study. Arch Ophthalmol 2007; 125:1249-54.
  4. Harwood RH. Visual problems and falls. Age and Ageing 2001; 30 (S4): 13-18.
  5. Casten, RJ. et al. Age-related macular degeneration and depression: a review of recent research. Curr Opin Ophthalmol 2004; 15:181-3.
  6. Jager, RD. et al. Age-related macular degeneration. N Engl J Med 2008; 358:2606-17.
  7. Honda S, Matsumiya W and Negi A. Polypoidal choroidal vasculopathy: Clinical features and genetic predisposition. Ophthalmologica 2014; 231(2):59-74.
  8. Uyama, M. et al. Polypoidal choroidal vasculopathy: natural history. Am J Ophthalmol 2002; 133 (5):639-648.
  9. American Academy of Ophthalmology. Polypoidal Choroidal Vasculopathy (PCV) – Asia Pacific, October 2014. https://www.aao.org/topic-detail/polypoidal-choroidal-vasculopathy-pcv--asia-pacific (last accessed: 28 November 2016)
  10. Kwok, AK. et al. Polypoidal choroidal vasculopathy in Chinese patients. Br J Opthalmol 2002; 86 (8):892-897.
  11. Raymond LMW, Timothy YYL: Polypoidal Choroidal Vasculopathy: An Update on Therapeutic Approaches. J Ophthalmic Vis Res. 2013 Oct; 8(4): 359–371
  12. Hayashi, H. et al. CFH and ARMS2 variations in age-related macular degeneration, polypoidal choroidal vasculopathy, and retinal angiomatous proliferation, Invest Ophthalmol Vis Sci 2010; 51 (11):5914-5919.
  13. Gotoh N, et al. Correlation between CFH Y402H and HTRA1 rs11200638 genotype to typical exudative age-related macular degeneration and polypoidal choroidal vasculopathy phenotype in the Japanese population. Clin Experiment Ophthalmol 2008; 36 (5):437-442.
  14. Cackett, P. et al. Relationship of smoking and cardiovascular risk factors with polypoidal choroidal vasculopathy and age-related macular degeneration in Chinese persons. Ophthalmology 2011; 118 (5):846-852.
  15. Ross RD, Gitter KA, Cohen G et al. Idiopathic polypoidal choroidal vasculopathy associated with retinal arterial macroaneurysm and hypertensive retinopathy. Retina 1996; 16 (2): 105–111.
  16. Sho K, Takahashi K, Yamada H et al. Polypoidal choroidal vasculopathy: Incidence, demographic features, and clinical characteristics. Arch Ophthalmol 2003; 121 (10): 1392–1396.

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APBN Editorial Calendar 2018
January:
Obesity / Outlook for 2018
February:
Searching for the fountain of youth
March:
Women in Science - Making a difference
April:
Digestive health in the 21st century - Trust your guts
May:
Dental health - The root to good health
June:
Cancer - Therapies and strategies for better patient outcomes
July:
Water management - Technologies for biotech and pharmaceutical industries
August:
Regenerative technology - Meat of the future
September:
Doctor Robot - The digital healthcare revolution
October:
Bones / Breast cancer
November:
Liver health / Top science research nations & institutions
December:
AIDS / Breakthrough of the year/Emerging trends
Editorial calendar is subjected to changes.
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