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칼라, '첫 스테로이드계' 안구건조증 신약 “FDA 승인” - 바이오스펙테이터

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칼라, '첫 스테로이드계' 안구건조증 신약 “FDA 승인”

입력 2020-10-28 17:20 수정 2020-10-28 19:43

바이오스펙테이터 서윤석 기자

코티코스테로이드계 약물 ‘아이서비스’..2주내 치료효과 보여..연말내 미국서 출시 예정

칼라 파마슈티컬스(Kala Pharmacuticals)의 안구건조증 신약이 미국 식품의약국(FDA)의 판매 허가를 받았다. 안구건조증을 적응증으로 승인받은 첫 스테로이드계 약물로 2주내 치료효과를 보여 기존 약물과 차별성을 가진다.

칼라는 28일(현지시간) 안구건조증 약물 ‘아이서비스(EYSUVIS, loteprednol etabonate ophthalmic)’를 FDA에서 승인했다고 밝혔다.

아이서비스는 안구건조증에 대한 첫 스테로이드계 약물로 객관적 지표(sign)와 주관적 증상(symptom)을 2주내 유의하게 개선한 약물이다. 칼라는 올해 말부터 미국에서 아이서비스를 시판할 계획이다.

시장조사기관 이벨류에이트파마는 아이서비스가 2024년까지 약 7억달러의 매출을 올릴 수 있을 것으로 예측했다. 또, 칼라는 아이서비스가 급성 안구건조증 환자들을 대상으로 틈새시장에서 높은 점유율을 차지할 것으로 기대하고 있다. 아이서비스는 치료 후 2주내에 효과를 나타내기 때문에 경쟁약물인 애브비/앨러간(Abbvie/Allergan)의 ‘레스타시스(Restasis)’, 노바티스(Novarits)의 ‘자이드라(Xiidra)’와 차별성을 가진다. 레스타시스와 자이드라는 투여 후 3~6개월이 지나야 효과가 나타난다.

미국 FDA는 객관적 지표와 주관적 증상을 반복해서 개선한 결과를 바탕으로 아이서비스를 승인했다. 안구건조증의 임상은 다른 약물과는 다르게 임상 기준인 객관적 지표와 주관적 증상을 3번의 임상에서 2번 이상 유의미하게 개선한 것을 입증해야 한다.

칼라는 1번의 임상 2상과 3번의 임상 3상을 진행해 아이서비스의 효과를 입증했다. 특히, 아이서비스는 3번의 임상 3상에서 모두 객관적 지표인 결막출혈(conjunctival hyperemia, CH)를 유의미하게 개선했다. 또, 전체치료집단(ITT)보다 기준선에서 더 심한 불편함(severe baseline symptom)이 있는 하위그룹에서 주관적 증상인 안구불편도(ocular discomfort severity, ODS)를 3번의 임상에서 2번 유의미하게 개선했다.

Mark Iwicki 칼라 CEO는 “안구건조증 환자를 위해 단기간 치료효과를 보도록 개발된 약물로 안전하고 효과적이며 신속한 치료효과를 보인다”며 “아이서비스를 안구건조증에 대한 1차 치료제로 사용되는 것을 목표로 개발했으며, 이번에 FDA 승인이란 중요한 성과를 이끈 임상 관계자분들에게 감사한다”고 말했다.

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