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Continuous ranibizumab delivery via a Port Delivery System (PDS) with refill exchanges every 24 weeks has been found to provide non-inferior outcomes compared to monthly intravitreal injections for individuals with diabetic macular edema (DME).
A phase 3 multicenter study looked at 634 participants randomized to receive either PDS Q24W or monthly ranibizumab. Best-corrected visual acuity (BCVA) from baseline over weeks 60 and 64 showed an increase of 9.6 letters for PDS and 9.4 letters for monthly ranibizumab, meeting noninferiority criteria. Interestingly, PDS individuals initially experienced a transient mean decrease of 6.7 letters 4 weeks post-implantation, but BCVA recovered to match monthly ranibizumab by week 16. Ultimately, central subfield thickness reductions were comparable between both PDS and intravitreal treatment.
It was also found over 95% of PDS individuals did not require supplemental treatment during refill-exchange intervals, demonstrating consistent efficacy. However, adverse events were more common in the PDS group (27.5% vs 8.9%) - but no cases of endophthalmitis or retinal detachment were reported.
The results suggest PDS offers an exciting treatment alternative for DME, greatly reducing treatment burden while maintaining efficacy comparable to monthly injections. Last month, the FDA approved PDS with refill exchanges every 24 weeks for individuals with DME, representing a significant advancement in long-term management for our patients.
-JRM
Go to article in JAMA Ophthalmology HERE.
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