Diana V. Do, MD, presented details of the PHOTON study at the Association for Research in Vision and Ophthalmology annual meeting, held recently in New Orleans, highlighting the safety and efficacy of 8 milligrams of aflibercept.
Editor’s note: This transcript has been edited for clarity.
I'm David Hutton of Ophthalmology Times. I'm joined today by Dr. Diana Do, who will be discussing the PHOTON data she presented at the recent ARVO annual meeting in New Orleans. Thank you so much for joining us today. Tell us about the data.
It's pleasure to join you. I had the pleasure of presenting the PHOTON 48-week results at ARVO, and this is a very important pivotal clinical trial that looked at high-dose aflibercept. High-dose aflibercept is 8 milligrams of aflibercept, which is 4 times the molar dose of the current FDA approved 2 milligrams of aflibercept. First, let's look at some background.
Why was 8 milligrams of aflibercept developed? Well, we know in clinical practice that the frequency of anti-VEGF injections provides a burden for our patients. and many patients have suboptimal visual acuity outcomes, because they're just not receiving enough VEGF suppression. Preclinical studies in animals showed that increasing the molar dose of aflibercept by 4 times nearly tripled the intraocular half-life of the drug. And therefore, 8 milligrams of aflibercept was developed for human use.
The PHOTON study looked at eyes with diabetic macular edema, and randomized them to either 8 milligrams of aflibercept given every 12 or 16 weeks, compared to the standard 2 milligrams of aflibercept. And we saw in these clinical trials that both eight milligram doses of aflibercept met the primary endpoint, and these groups had noninferior visual acuity gains, compared to the standard 2 milligram dose. But more importantly, 91% of patients that were randomized to Q 12 dosing of 8 milligrams of aflibercept, were able to maintain this dosing interval through the first year at 9% of patients that were randomized to 8 milligrams of precept every 16 weeks, were also able to stay with this dosing interval.
If you look at the entire total, 93% of patients with high-dose 8 milligrams of aflibercept were able to be dosed 12 weeks or beyond, which is very exciting because this provides sustained VEGF inhibition, while giving robust visual acuity gains and rapid reductions in retinal thickness.
In terms of safety, was 8 milligrams of aflibercept safe? It was. When we looked at rates of intraocular inflammation, the totality of the safety data indicated that 8 milligrams of aflibercept was comparable to 2 milligrams of aflibercept and there are no cases of occlusive retinal vasculitis. In addition, the systemic safety profile was also well tolerated with no systemic safety signals. I'm very excited about this data and hopefully in the near future, 8 milligrams of aflibercept will be a viable treatment option for patients with diabetic macular edema.