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October 13, 2020
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Robotics could optimize subretinal delivery of gene therapies

Injection in the subretinal space, currently performed or investigated for several cell-based and gene therapy procedures, could soon become more precise and safer with the help of robotics.

“Robotics can offer precision, accuracy and that degree of steadiness that is key for successful subretinal delivery,” Marc de Smet, MD, PhD, said at the virtual Euretina congress.

Gene therapy is advancing quickly, and one option, Luxturna (voretigene neparvovec, Novartis), is on the market at the price of US$425,000 per injection. Subretinal delivery is a delicate procedure that requires exact targeting of the space, without penetrating too deep and without causing reflux into the vitreous.

“Very few surgeons are trained to do this, and reflux has been shown to occur in virtually all cases with Luxturna, which means that 30% to 50% of the amount is dispersed into the vitreous. The challenges of subretinal delivery have so far been a hurdle in the way of drug development,” de Smet said.

Robotics could be the way to standardize the technique, allowing a large number of surgeons to perform subretinal delivery in a safe and precise manner, injecting the exact amount of drug in the exact place.

“We are working at this with our Preceyes surgical system. We can optimize the procedure, reduce reflux, and hopefully we will gain some traction with companies since we can help them improve their ability to carry out their phase 2 and 3 studies,” de Smet said.

In a mini trial at Euretina in 2019, surgeons were invited to inject into an artificial retina manually and then robotically with the Preceyes system. Tremor and drift around the point of insertion were reduced from 40 µm to 300 µm manually, depending on the individual surgeon, to a consistent 1 µm to 2 µm robotically.

“We also found that the surgeons were allowing more time for the injection, performing it slowly and calmly with the robotic system, while they hastened the manual injection because they had trouble holding it in the correct position,” de Smet said.