Credit to Aldeyra Therapeutics for discontinuing development of its lead project, reproxalap, in noninfectious anterior uveitis after yesterday’s phase III flop. But the company has more lucrative uses in mind for the asset, and it will hope that the latest data do not bode ill in dry eye disease and allergic conjunctivitis. Aldeyra highlighted the differences between the disorders during yesterday’s conference call, but the gains the group’s stock made in March when it reported positive data in allergic conjunctivitis have now been erased. The next readout will involve a topical dermal formulation of reproxalap in Sjögren-Larsson syndrome, but the big one is the Renew trial in dry eye disease; a potentially longer-lasting formulation of the eyedrop is also in phase II in dry eye. Aldeyra has not nailed down details of its second phase III study in allergic conjunctivitis, but seems convinced that the FDA will agree to an allergen chamber trial, which would be less risky than a study involving natural exposure to pollen during the allergy season. Aldeyra will meet the agency in the second half and report back; any change in its plans could see it punished again.
|Eyeing new markets: reproxalap's key trials|
|Trial name||Setting||Trial ID||Data due||2024e indication sales ($m)|
|Solace||Noninfectious anterior uveitis||NCT03131154||Failed||1|
|Reset||Sjögren-Larsson Syndrome||NCT03445650||Part 1 data H2 2019||-|
|Phase II study (new formulation)||Dry eye disease||NCT03916042||H2 2019/early 2020||182|
|Renew||Dry eye disease||NCT03879863||Part 1 data late 2019/early 2020|
|Source: EvaluatePharma, clinicaltrials.gov.|