Industry News — Clinical Updates

Two-Year Results of Phase 3 VISTA Trial of Aflibercept for DME Treatment Show Sustained Vision Improvement

In the phase 3 VISTA-DME trial of aflibercept for treating diabetic macular edema (DME), aflibercept 2 mg dosed monthly (2q4) and 2 mg dosed every 2 months (after 5 initial monthly injections, 2q8) showed sustained improvement from baseline in best corrected visual acuity (BCVA) at week 100, compared with laser photocoagulation. These results were announced on February 10 by Regeneron Pharmaceuticals, Inc. (Tarrytown, NY) and Bayer HealthCare (Leverkusen, Germany).

VISTA-DME trial patients were randomized to receive aflibercept 2q4 (n = 155), aflibercept 2q8 (n = 152), or the comparator treatment of laser photocoagulation (n = 154).

After 2 years, mean BCVA improved 11.5 letters in the aflibercept 2q4 group (12.5 letters at 52 weeks) and 11.1 letters in the 2q8 group (10.7 letters at 52 weeks). Patients in the laser photocoagulation group had a mean BCVA improvement of 0.9 letters (0.2 letters at 52 weeks).

Aflibercept was generally well tolerated, and adverse reactions across the aflibercept and laser control groups were similar and typical of those seen in anti-VEGF studies in patients with diabetes receiving intravitreal anti-VEGF therapy. The most common adverse reactions included conjunctival hemorrhage, eye pain, and vitreous floaters. The most frequent non-ocular adverse reactions included hypertension, anemia, and urinary tract infection.  

Arterial thromboembolic events (nonfatal stroke, nonfatal myocardial infarction, and vascular death) as defined by the Anti-Platelet Trialists’ Collaboration (APTC) were similar across the aflibercept and laser control groups. Events occurred in 13 out of 155 patients in the aflibercept 2q4 group, 11 out of 152 in the aflibercept 2q8 group, and 9 out of 154 in the laser group. Eight out of 155 patients in the aflibercept 2q4 group died, compared to 4 out of 152 in the aflibercept 2q8 group, and 3 out of 154 in the laser treatment group.

Full 2-year VISTA-DME data will be presented at upcoming conferences, and 2-year data from the VIVID-DME trial are expected later in 2014. Regeneron and Bayer HealthCare confirmed that both the VISTA-DME and the VIVID-DME trials will continue as planned up to 148 weeks.

Updated: February 12, 2014