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Reproxalap non-inferior to Pred Forte for noninfectious anterior uveitis in phase 2 trial
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A phase 2 clinical trial showed topical ocular reproxalap to be non-inferior to Pred Forte in patients with noninfectious anterior uveitis, Aldeyra Therapeutics announced in a press release.
The randomized, multicenter, investigator-masked, comparator-controlled, parallel-group trial found reproxalap 0.5%, an aldehyde sequestering agent, was non-inferior to Pred Forte (prednisolone, Allergan) after 2 weeks (P = .036) and 4 weeks (P = .048) in reducing anterior chamber inflammatory cell count.
A combination of reproxalap and twice-daily Pred Forte was also statistically non-inferior to four-times-daily Pred Forte monotherapy, the release said.
A phase 3 trial of reproxalap vs. vehicle in up to 100 patients with noninfectious anterior uveitis is under way, with results expected to be announced in the second half of 2018.
“The use of corticosteroid therapy for the treatment of ocular inflammation is hampered by ophthalmic toxicity, including cataract formation, secondary infection, viral reactivation, delayed wound healing and elevated intraocular pressure that can cause irreversible glaucomatous optic atrophy,” John D. Sheppard, MD, an expert in ocular inflammation, said in the release. “Reproxalap could represent a welcome addition to the topical therapeutic options available to practitioners who treat noninfectious anterior uveitis.”