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|Ocular Therapeutix™ Announces FDA Acceptance of NDA Resubmission for DEXTENZA™ for the Treatment of Ocular Pain Occurring After Ophthalmic Surgery|
PDUFA target action date set for
DEXTENZA initial target market comprises nearly 4 million cataract surgeries in the U.S.
“We are pleased the
DEXTENZA™ (dexamethasone insert) 0.4mg is placed through the punctum, a natural opening in the eye lid, into the canaliculus and is designed to deliver a tapered dose of dexamethasone to the ocular surface for up to 30 days. Following treatment, DEXTENZA resorbs and exits the nasolacrimal system without need for removal. The Company has completed three Phase 3 clinical trials with DEXTENZA for the treatment of post-surgical ocular inflammation and pain. Subject to the approval of the NDA for post-surgical ocular pain by the FDA, Ocular Therapeutix intends to promptly submit an NDA supplement for DEXTENZA to broaden its label to include a post-surgical inflammation indication. DEXTENZA is also in Phase 3 development for the treatment of ocular itching associated with allergic conjunctivitis.
About Ocular Pain and Inflammation Following Ophthalmic Surgery
Ocular pain and inflammation are common side effects following ophthalmic surgery. Physicians prescribe topical corticosteroids as part of the standard of post-operative care. If left untreated, inflammation of the eye may result in further ocular complications, which in some cases may cause permanent loss of vision. According to US Census data, by the year 2020 it is estimated that the number of Americans diagnosed with cataracts is expected to rise to approximately 30 million, representing a 32% increase over current prevalence estimates.
According to Market Scope, approximately 3.9 million cataract cases and over 5.6 million total ocular surgeries were expected to be performed in the United States in 2016.
Forward Looking Statements
Any statements in this press release about future expectations, plans
and prospects for the Company including the development and regulatory
status of the Company’s product candidates, such as the Company’s
expectations and plans regarding regulatory submissions for and the
timing and conduct of clinical trials of DEXTENZA™ for the treatment of
post-surgical ocular inflammation and pain, including our expectations
regarding the resubmission of the NDA filed with the FDA and potential