JETREA

The actual benefit of JETREA is :

- substantial in patients with vitreomacular traction, isolated or associated with macular hole of ≤400 μm, the symptoms of which do not immediately necessitate vitrectomy,

Since :

- the efficacy of JETREA has been studied only in patients with vitreomacular traction, isolated or associated with macular hole of diameter of less than or equal to 400 μm and the symptoms of which did not immediately justify vitrectomy, corresponding to patients who are not severely affected, i.e. a subpopulation of the Marketing Authorisation indication for JETREA.

For these patients who are not severely affected,
- it was expected that the administration of JETREA reduces or even eliminates the need for surgical vitrectomy which has a high success rate but is not free from risks, which has not been demonstrated,

- the efficacy of JETREA, with follow-up limited to 6 months, is modest,

the Committee believes that JETREA provides a minor improvement in actual benefit (IAB IV) in the management of a subpopulation of the Marketing Authorisation represented by patients with vitreomacular traction, isolated or associated with macular hole of diameter less than or equal to 400 μm and for whom the symptoms do not immediately necessitate vitrectomy.