Table 4.

Treatment-emergent ocular adverse events in the intervention group in 1 year (mITT)

	Participants (n=20)	Number of events	Severity	Outcome
Elevated intraocular pressure	4 (20%)	5	Mild	Recovered or resolved
Cataract	3 (15%)	4	Mild	Ongoing in two participants; recovered or resolved in one participant (following extraction)
Retinal tear	2 (10%)	2	Mild to moderate	Recovered or resolved (following laserpexy)
Eye inflammation	2 (10%)	6	Mild	Recovered or resolved
Conjunctival cyst	1 (5%)	1	Mild	Recovered or resolved
Conjunctivitis viral	1 (5%)	1	Mild	Recovered or resolved
Eye irritation	1 (5%)	1	Moderate	Recovered or resolved
Eye pain	1 (5%)	1	Mild	Recovered or resolved
Eye pruritus	1 (5%)	1	Moderate	Ongoing
Eye swelling	1 (5%)	1	Mild	Recovered or resolved
Foreign body sensation in eyes	1 (5%)	1	Mild	Recovered or resolved
Iritis	1 (5%)	1	Mild	Recovered or resolved
Macular hole/degeneration	1 (5%)	2*	Mild to moderate	Recovered or resolved with sequelae; recovered or resolved
Maculopathy/epiretinal membrane	1 (5%)	2	Mild	Ongoing
Pseudopapilledema†	1 (5%)	1	Mild	Recovered or resolved
Retinal hemorrhage	1 (5%)	1	Mild	Recovered or resolved

One participant in the control group experienced 1 event of photopsia, which was classified as mild and resolved without sequelae. mITT=modified intention to treat.

^*In the same eye of a single subject, a full-thickness macular hole spontaneously resolved (with sequelae) to thinning, which subsequently resolved (without sequelae). This was classified as two adverse events, but occurred in the same clinical course of events.

^†Disc elevation unrelated to increased intracranial pressure or optic nerve oedema.