"The need to reduce exposure to the deleterious side effects of corticosteroids are well known within the ophthalmology community," commented Dr.
Forty-five subjects were randomized equally to receive 0.5% ADX-102 four times daily, Pred Forte® (a corticosteroid) four times daily (tapered), or 0.5% ADX-102 four times daily and Pred Forte® twice daily (tapered). There were no statistical differences among all groups for the clinical endpoints, including anterior chamber cell count and ocular flare. ADX-102 was generally well tolerated and there were no serious adverse events, consistent with previous Phase 1 and Phase 2 clinical trials.
ADX-102 produced clinically meaningful effects on anterior chamber cell counts (ACC) comparable to corticosteroid. After four weeks of therapy, 53% of ADX-102-treated patients achieved ACC Grade 0 (zero or one cells) versus 38% for that of corticosteroid-treated patients. Rescue medication was required in 20% of ADX-102-treated patients versus 38% of corticosteroid-treated patients. In the safety population, clinically significant elevations of intraocular pressure were observed in corticosteroid-treated patients but not in ADX-102-treated patients. Mean intraocular pressure increased in the corticosteroid group, but decreased slightly in the ADX-102 group.
Aldehyde mediators are thought to broadly induce inflammation, including allergic disease such as allergic conjunctivitis and autoimmune disease such as NAU. Thus, ADX-102 and other aldehyde sequestering agents represent a novel anti-inflammatory approach. In
"In both autoimmune and allergic ocular inflammation, we have demonstrated in our first series of controlled Phase 2 clinical trials that ADX-102's novel aldehyde trapping mechanism produces clinically relevant effects comparable to existing therapies, along with evidence of a safety profile that could become an important option for clinicians treating patients with inflammatory disease," commented
About Noninfectious Anterior Uveitis
Noninfectious anterior uveitis is a rare, potentially blinding disease that may be mediated in part by pro-inflammatory aldehydes, and is characterized by inflammation in the front of the eye, pain, impaired vision, and photophobia.
About Allergic Conjunctivitis
Allergic conjunctivitis is a common allergic disease that is thought to be mediated in part by pro-inflammatory aldehydes, and is characterized by inflammation of the conjunctiva (a membrane covering part of the front of the eye), resulting in ocular itching, excessive tear production, lid swelling, and redness.
About Dry Eye Syndrome
Dry Eye Syndrome is a common inflammatory disease characterized by insufficient moisture and lubrication over the anterior surface of the eye. Symptoms may include ocular irritation, burning, stinging, visual fluctuations, blurring, and, in severe cases, corneal ulceration. In patients with Dry Eye Syndrome, aldehydes may contribute to ocular inflammation as well as the impairment of lipids (fats) that lubricate the ocular surface.
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