BioWorld
Orion
Before the decision to wind down, the company had high hopes for its Orion visual cortical prosthesis system. The company saw the potential for the product to provide useful artificial vision to individuals blind from many causes, such as glaucoma, eye injury, diabetic retinopathy, optic nerve disease or injury and retinitis pigmentosa.
Indeed, during the company’s March 19 fourth-quarter earnings call, COO Pat Ryan provided an update on the company’s Orion early feasibility study. Specifically, it had wrapped up the 12-month testing for the sixth and final subject in February. Ryan detailed some results, noting that on square localization, 83% of individuals scored significantly better with the device on than off. All individuals scored significantly better with the device on than off on direction of motion.
“From a safety perspective, as previously shared, there was one serious adverse event in seven nonserious adverse events over the same time period. These results are extremely encouraging, and we believe sufficient to support moving forward with a pivotal study in the U.S.,” Ryan said.
The company had reached an agreement with the U.S. FDA on the primary efficacy endpoint for the pivotal trial, which will be FLORA [Functional Low Vision Observer Rated Assessment] 20. As of that date, three of 15 subjects have begun participation in the FLORA 20 validation. “However, due to COVID-19 social distancing protocols, we have suspended validation efforts until further notice,” he said at the time.
Kyle Bauser from Dougherty & Co. asked whether COVID-19 had had an impact on the IDE application, given that it was now slated for the first half of next year. Ryan said no, adding that the company was being conservative in light of ongoing discussions with the FDA.
Competition
For its part, a big competitor of Second Sight, Paris-based Pixium Vision SA, reported March 31 positive follow-up data from a feasibility trial of the Prima system in patients with dry age-related macular degeneration (AMD). Specifically, the Prima system sustainably elicited light perception in all four dry AMD patients with favorable safety profile. The company said the results build on the previously reported positive 12-month clinical data. The Prima system is intended to partially replace the normal physiological function of the eye’s photoreceptor cells by electrically stimulating the nerve cells of the inner retina. Those then transmit the visual information to the brain via the optic nerve.
But COVID-19 is having an impact on this company as well. Pixium reported March 23 that it had decided to postpone continuing its feasibility studies in France and the U.S., aside from ongoing safety monitoring. It added that the initiation of the PRIMAvera pivotal study with the Prima system in dry AMD may be delayed.
