Cambium Bio (ASX: CMB) has received approval from the US Food and Drug Administration (FDA) for a protocol relating to Phase 3 clinical trials of its Elate Ocular treatment for moderate-to-severe dry eye disease.
The approval represents a key milestone in advancing Elate Ocular towards market registration and follows the FDA granting the product fast-track designation in December.
Fast-tracking helps expedite the review of drugs that treat serious conditions and address unmet medical needs.
Chief executive officer Karolis Rosickas said the Phase 3 protocol was pivotal to the development of the Elate Ocular trials.
“The trial design reflects extensive consultation with regulatory experts and key opinion leaders to ensure we meet FDA requirements for registration,” he said.
The fast-track designation will enable Cambium to have more frequent interactions with the FDA throughout Elate Ocular’s development process and makes the product eligible for potential accelerated approvals and priority reviews.
“With fast-track designation now secured and the protocol approved, we are well positioned to advance Elate Ocular through its final stages of clinical development.”
The Phase 3 program consists of two identical randomised, double-blinded, vehicle-controlled trials to evaluate the safety and efficacy of Elate Ocular compared to a placebo.
The trials will enrol a total of 800 patients at sites in the US and Australia over a treatment period of nine weeks commencing with a two-week run-in, while a subset of patients will participate in a 43-week long-term safety follow-up.
Cambium is in advanced discussions with several contract research organisations and expects to finalise the selection shortly.
The company anticipates starting the first round of enrolments by mid-year and having top-line data available by mid-2026.
Dry eye disease is a chronic condition affecting millions of people worldwide, with a prevalence of 6.8% in the US and up to 50% in Asian countries.
Current treatment options provide only temporary symptom relief and are associated with significant side effects and low patient compliance.
The US market for dry eye treatments exceeds $3.15 billion annually and continues to grow as the population ages and screen time increases.
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