Intraocular Pressure Outcomes with Intravitreal Aflibercept 8 mg: A 96-Week Pooled Analysis from PULSAR and PHOTON

Area of Science:

• Ophthalmology
• Retinal Diseases
• Pharmacology

Background:

• Neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME) are leading causes of vision loss.
• Aflibercept is a key treatment for these conditions, with ongoing research into optimized dosing and delivery.
• Higher volume injections may offer improved efficacy but require safety evaluation, particularly regarding intraocular pressure (IOP).

Purpose of the Study:

• To evaluate the safety and efficacy of a higher injection volume of aflibercept (8 mg) compared to the standard volume (2 mg) in patients with nAMD and DME.
• To assess the effect of increased aflibercept injection volume on intraocular pressure (IOP) and glaucoma-related adverse events.

Main Methods:

• Data from the PULSAR (nAMD) and PHOTON (DME) trials were pooled.
• Patients received aflibercept 2 mg every 8 weeks or 8 mg every 12 or 16 weeks after initial doses.
• Intraocular pressure (IOP) measurements and glaucoma-related treatment-emergent adverse events (TEAEs) were monitored up to week 96.

Main Results:

• The safety analysis included 1667 patients; 1164 received 8 mg and 503 received 2 mg aflibercept.
• Rates of glaucoma-related TEAEs, including IOP increases, were low and similar between the 8 mg and 2 mg groups (9/1000 vs 6/1000 injections).
• Mean pre-injection IOP levels remained stable over time, with no sustained increase observed across treatment arms.

Conclusions:

• Aflibercept 8 mg administered at higher volumes demonstrated comparable IOP outcomes to aflibercept 2 mg.
• No significant long-term increase in IOP or glaucoma-related safety issues were identified with the higher volume aflibercept injections through 96 weeks.