German pharmaceutical company Bayer announced that its anti-VEGF treatment aflibercept solution for injection into the eye is effective as monotherapy in patients who have Polypoidal Choroidal Vasculopathy (PCV), a subtype of wet age-related macular degeneration (wet AMD), most prevalent in Asian populations.
The announcement was a part of the two-year PLANET study results which were presented for the first time at the 11th Asia-Pacific Vitreo-retina Society (APVRS) Congress on December 9, 2017 in Kuala Lumpur.
This important finding was from the PLANET study - efficacy and safety of intravitreal aflibercept in polypoidal choroidal vasculopathy: PLANET 2-year clinical trial in PCV conducted mainly in Asia Pacific i.e. Australia, Japan, Hong Kong, Singapore, South Korea, and Taiwan.
Polypoidal Choroidal Vasculopathy is an important, but frequently underdiagnosed, subtype of wet AMD. It is characterized by abnormal growth of blood vessels ending in polyps.
The robust two-year results demonstrated effectiveness of aflibercept as monotherapy in PCV prevalent in Asia Pacific. Over 80% of patients showed no active polyps in both treatment arms at the end of the study. Results support aflibercept monotherapy as the preferred first-line treatment option for PCV, hence avoiding the additional time burden and side effects of combination PDT treatment
Existing studies show that anti-VEGF treatments improve vision in PCV when used in combination with photodynamic therapy (PDT), a type of laser eye treatment. However, PDT may cause light sensitivity for the skin and eyes after treatment, and in some cases may cause some damage to nearby healthy tissue such as burns, swelling, pain, and scarring.
The completed PLANET study shows that aflibercept improved vision in PCV patients without the need for PDT (laser eye therapy) with verteporfin. The full results at 96 weeks demonstrate that aflibercept monotherapy was non-inferior in mean improvement of best-corrected visual acuity (BCVA) as compared to aflibercept plus active rescue PDT.
Professor Tien Yin Wong, principal investigator of the PLANET study and retinal specialist at Singapore National Eye Centre, said, “Wet AMD is a leading cause of blindness globally and many Asian patients tend to have PCV. Over the two years of the PLANET study, the anti-VEGF agent aflibercept given as a monotherapy was effective for the majority of PCV patients and adding rescue PDT when given according to the study protocol did not provide additional functional or anatomic benefits.
“This signifies that for most patients, anti-VEGF monotherapy using agents such as aflibercept can be established as a preferred first-line treatment option for patients with visual impairment due to PCV as this approach avoids the added burden and side effects of combination therapy with PDT. Additionally, it is encouraging that in the PLANET study, among patients treated with the anti-VEGF agent aflibercept as a monotherapy approach, more than 80% did not have active polyps at the end of the two year study. However, longer term studies are needed to further clarify the role of polyp outcomes in the management of PCV,” he added.
PLANET is a 96-week, randomized, double-masked, sham-controlled, phase 3b/4 study assessing the efficacy and safety of aflibercept monotherapy (plus sham PDT) and aflibercept in combination with PDT, in patients with PCV, a subtype of wet AMD. A total of 333 men and women aged =50 years at 62 study sites mainly in Asia Pacific i.e. Australia, Japan, Hong Kong, Singapore, South Korea, and Taiwan, as well as Germany and Hungary, participated in the trial.
It is projected that about 17 million people in Asia Pacific will have wet AMD by 2040 PLANET adds to the growing body of evidence in Asia Pacific supporting the proactive use of aflibercept in wet AMD management.
More recently, the ALTAIR Treat and Extend study presented at the 17th EURETINA Congress in Barcelona, shows similar robust vision improvement in Japanese patients receiving aflibercept in both two weekly and four weekly extension regimens, demonstrating the efficacy of aflibercept in longer treatment intervals.