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New Eye drops found effective in Allergic Conjunctivitis in Clinical Trial


New Eye drops found effective in Allergic Conjunctivitis in Clinical Trial

New Eye drops show positive results and have been found effective for Allergic Conjunctivitis in Clinical Trial.

Positive results from the New Phase 3 ALLEVIATE Trial of 0.25% and 0.5% reproxalap topical ophthalmic solution in patients with allergic conjunctivitis have been announced. The clinical trial met the primary endpoint and the key secondary endpoint for both concentrations of reproxalap.

  • Primary endpoint of ocular itch score area under the curve achieved for both tested reproxalap concentrations
  • Key secondary endpoint of clinically relevant two-point ocular itch score improvement achieved for both tested reproxalap concentrations

The investigative solution, from biotechnology company Aldeyra Therapeutics, showed in the Trial results that patients met the primary efficacy endpoint of improved ocular itching, as well as key secondary endpoints, for both .25% and .50% solution.

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The double-masked, randomized, vehicle-controlled, multi-center, parallel-group conjunctival allergen challenge Phase 3 ALLEVIATE trial assessed the efficacy and safety of 0.25% and 0.5% concentrations of reproxalap topical ophthalmic solutions compared to vehicle in 318 patients (approximately 100 per arm) with seasonal allergic conjunctivitis. The primary efficacy endpoint was the evaluation of ocular itch score (0 to 4 scale) area under the curve from 10 to 60 minutes after allergen challenge, and the key secondary endpoint was two-point responder rate, a measure of clinical relevance.

Patients treated with .25% and .50% reproxalap reported statistically significant reductions in ocular itching when compared to those on vehicle (P < .0001; P = .0025, respectively). In two-point responder rates, patients on the 2 doses also reported statistically greater metrics than vehicle (P = .0005; P = .0169), and an anti-inflammatory profile that is notably distinct from current allergic conjunctivitis standard-of-care antihistamine.

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The differentiated mechanism of action, as well as these promising phase 3 results, could spell reproxalap’s role in future marketed conjunctivitis therapies, Aldeyra Chief Medical Officer David Clark, MD, MRCP, said.

“We are thrilled to announce positive results from ALLEVIATE, our first completed Phase 3 clinical trial,” commented Todd C. Brady, M.D., Ph.D., President and CEO of Aldeyra. “Consistent with positive results from five prior Phase 2 clinical trials in ocular inflammation, today’s announcement confirms the potential of reproxalap as a novel and clinically meaningful approach for the treatment of allergic conjunctivitis. Given that approximately half of allergic conjunctivitis patients also suffer from ocular dryness, we believe the ALLEVIATE results highlight the relevance of reproxalap to our current Phase 3 program in dry eye disease.”

With the new ALLEVIATE results, reproxalap has now been tested in more than 700 patients across 7 clinical trials. No concerns regarding safety nor tolerability were observed in any clinical experiences involving reproxalap, and the only observed adverse events have been mild and transient instillation site irritation.

“There is a large allergic conjunctivitis patient population that is underserved by currently available medications,” stated David J. Clark, M.D., M.R.C.P., Chief Medical Officer of Aldeyra. “The ALLEVIATE results suggest the potential of topical ocular reproxalap as a novel, safe, and effective therapeutic option that could be used to complement existing therapy before resorting to corticosteroids, which can lead to serious ocular toxicity.”

In the latter half of this year, Aldeyra intends to meet with regulatory authorities to discuss the new phase 3 results, and to better understand the remaining parameters of a New Drug Application (NDA) submission to the US Food and Drug Administration (FDA).




Source: self

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