Pixium Vision is developing Prima, a potentially breakthrough wireless sub-retinal implant that generates electrical impulses at the retinal bipolar cell level to restore a form of central visual perception in patients with advanced retinal disease. While competing retinal implants generally target rare conditions involving near-total blindness, Prima seeks to address initially a larger unmet market indication, dry age-related macular degeneration (Dry-ARMD). Prima started human feasibility studies in late 2017 and could start EU pivotal trials in H119. Using a risk-adjusted NPV model, we obtain a pipeline rNPV of EUR 77.4m, down from EUR 82.6m previously.
Pixium Vision recently reported data from its 10-patient Iris II study showing that it improves visual performance, but stops operating as intended at approximately nine to 12 months post-implantation. Pixium has halted new implantations as it plans to study a potential remedy to improve longevity. We have lowered our success probability estimates and delayed our launch dates for both Iris II and Prima. Our rNPV is reduced to EUR 63.0m, from EUR 129.3m previously.
Pixium is building up a sales channel across Europe for its Iris II device, and is working on securing reimbursement and generating initial product sales in H217. It is also planning to start first-in-human trials for the next-generation Prima implant in H217. Using a risk-adjusted NPV model, we obtain a pipeline rNPV of EUR 129.3m, compared to EUR 131.4m, previously.
Pixium reported FY18 financials and reiterated that it is on track to start a pivotal study in the EU for its Prima bionic vision system (BVS) in H219 for the treatment of advanced dry age-related macular degeneration (Dry-ARMD). This follows the release of positive six-month data in January 2019 for its five-patient EU Prima feasibility study. Using a risk-adjusted NPV model, we obtain a pipeline rNPV of €91.2m, vs €88.7m previously.
Pixium announced on 8 January 2019 that its Prima wireless photovoltaic sub-retinal implant successfully met the endpoints of the EU feasibility study at interim six months follow-up after implantation, in patients with advanced dry age-related macular degeneration (Dry-ARMD). Results are in line with preliminary data points reported in our 17 December 2018 note, and may also attract eligible candidates for its ongoing US feasibility study. Pixium believes the interim safety data could be used to enable the design of the protocol for a larger, multi-centre, CE Mark-enabling European pivotal study. The EU pivotal study may start recruitment in Q319, potentially resulting in initial implantations before YE19.
Pixium has been reporting encouraging signs of visual response and safety in the EU feasibility study for its Prima implant in recent conferences. The firm plans to report full interim data by early Q119, which, if positive, can support a regulatory filing towards an EU pivotal study, with the first implantations potentially occurring in Q319. Using a risk-adjusted NPV model, we obtain a pipeline rNPV of EUR 88.7m, vs EUR 90.6m previously.
Pixium's Prima sub-retinal wireless implant continues to advance through human feasibility trials. The EU study recently reached full enrolment and a US study is slated to start implantations in Q318. Using a risk-adjusted NPV model, we obtain a pipeline rNPV of €90.6m, vs €77.4m previously.
Pixium announced on 25 January 2018 the first human activation of the Prima wireless photovoltaic sub-retinal implant, following successful implantation one month ago. These events occurred as per the protocol of the five-patient European Prima feasibility study, which was approved by regulators in October 2017 to assess the device in patients who have lost light perception in their central visual field due to atrophic damage from atrophic dry age-related macular degeneration. Following Prima activation, the patient reported light perception in the central visual field, where there had been none previously, and will now proceed to visual re-training, to learn how to interpret the elicited light signals emitted by the Prima system. The successful Prima activation in this first patient is encouraging as an early suggestion of proof-of-concept that the device can interface with retinal cells to restore some visual perception. Additional implantations, along with results from the six-month safety assessment in this study, may further validate the Prima approach and potential.
Pixium has received clearance from the French regulatory agency (Agence Nationale de Sécurité du Médicament et des Produits de Santé, or ANSM) to start a feasibility study of its Prima sub-retinal bionic vision system (BVS) on up to five patients with advanced Dry-ARMD. It plans to complete the first implantation before YE17, and obtain six-month study data in H218. If results are positive, Pixium expects to start an EU pivotal study in H119. We have reinstated our Prima probability of success estimate in our model to 12.5% (from 10%), leading to an increase in our pipeline rNPV to EUR 82.6m (from EUR 63.0m, previously).
Pixium announced on 24 May 2017 that the French Haute Autorité de Santé (HAS) has requested additional clinical data before agreeing to provide exceptional reimbursement under the Forfait Innovation (FI) programme for Pixium's Iris II implant system. The HAS agreed that the Iris II meets the critical FI eligibility criteria of providing a sufficiently novel and innovative treatment for a significantly unmet medical need (patients severely visually impacted by retinitis pigmentosa). Pixium now plans to provide interim six-month data from its ongoing 10-patient European Iris-II study, which should be available in Q317, to fulfil this requirement. Hence we believe a decision from HAS on potential Iris-II reimbursement under FI is not likely before late Q317 or early Q417.
Pixium Vision is developing two different retinal implants that provide vision by electrically stimulating the retina. Commercialisation efforts for Iris II are starting in Europe. Prima intends to target a larger population, and human trials could start in H117. Using a risk-adjusted NPV model, we obtain a pipeline rNPV of EUR 131.4m, up from EUR 125.5m, previously.
Pixium announced this week that it has completed the 10th and final implantation as part of its ongoing European Iris-II study. This trial began in January 2016 and will assess the Iris II epi-retinal implant in patients with retinitis pigmentosa (RP) and certain other retinal dystrophies. While the study will assess the device for at least 18 months, interim data could be available in mid-2017 and would support reimbursement applications in European countries such as the UK, France and Germany.