DEC 08, 2017
Physicians may soon have a steroid alternative in their uveitis treatment toolkit: A phase 2 trial finds that the new aldehyde trap drug reproxalap (Aldeyra Therapeutics) is noninferior to prednisolone acetate (Pred Forte) at reducing ocular inflammation in patients with noninfectious anterior uveitis.
"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," says John D. Sheppard, MD, an expert in ocular inflammation and president of Virginia Eye Consultants.
The new treatment, previously known as ADX-102, is a first-in-class drug that reduces inflammation by sequestering aldehydes in the anterior chamber. The drug does not cause steroid-related side effects, such as increased IOP.
"Reproxalap could represent a welcome addition to the topical therapeutic options available to practitioners who treat noninfectious anterior uveitis," Sheppard says.
The randomized, controlled trial showed that reproxalap (0.5% ophthalmic solution) is statistically noninferior to the coticosteroid at reducing anterior chamber inflammatory cell count after 2 weeks or 1 month of monotherapy (both P<0.05). The study further reveals that a twice-daily Pred Forte-reprozalap combination therapy is statistically noninferior to 4-times-daily Pred Forte monotherapy.
A phase 3 clinical trial of reproxalap for uveitis is underway, with topline results expected in the second half of 2018. A separate phase 2 trial of reproxalap has shown that it also has the potential to relieve signs and symptoms of dry eye disease.