FDA accepts new drug application for presbyopia treatment
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The FDA has accepted a new drug application for CSF-1 for the treatment of presbyopia, according to a press release from Orasis Pharmaceuticals.
“The news of our NDA acceptance for CSF-1 is exciting for this expansive category,” Paul Smith, president and chief operating officer of Orasis Pharmaceuticals, told Healio. “We know that eye care providers are optimistic about the category and acknowledge the desire of many presbyopes to reduce their dependence on readers. Our optimized formulation with low-dose pilocarpine is designed to balance the efficacy patients desire with minimal adverse events, while providing dosing flexibility based on patient needs.”
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The submission is supported by data from the phase 3 NEAR-1 and NEAR-2 clinical trials, which included more than 600 patients, in which CSF-1 (low-dose pilocarpine hydrochloride 0.4%) met its primary and secondary safety and efficacy endpoints by Day 8 of testing. The eyedrop reportedly achieved statistically significant three lines or more gain in distance-corrected near visual acuity and no loss of one line or more in distance visual acuity for patients, according to the press release.
Adverse events were minimal, with 2.6% of patients overall reporting moderate treatment-related adverse events. The most common treatment-related adverse events included headache (6.8% of patients) and instillation site pain (5.8% of patients).
“We know there is significant interest in exploring various potential use cases for presbyopia drops by the community of eye care providers,” Smith said. “As our research has continued to show, different patients will want to manage their vision in different ways; we would expect consumer demand to generate research activity following FDA review and approval. In the meantime, we are pleased with FDA’s acceptance of our robust clinical package for CSF-1.”
The FDA has assigned a Prescription Drug User Fee Act goal date of Oct. 22.
Editor’s note: This article was updated on Feb. 21, 2023, to include comments from the chief operating officer of Orasis Pharmaceuticals.
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