Outlook Therapeutics (OTLK) said Tuesday the resubmission of its biologics license application for ONS-5010, an investigational ophthalmic formulation for the treatment of wet age-related macular degeneration, was accepted by the US Food and Drug Administration.
The agency's classification of the application as a class 2 review means that there will be a six-month review period from the date of resubmission, the company said.
Outlook said the FDA has set a Prescription Drug User Fee Act goal date of Aug. 27, by which it must respond.
The company also said it plans to brand the treatment as Lytenava in the US if approved by the agency, adding that it expects to receive 12 years of regulatory exclusivity.
The shares were up over 9% in recent trading.
Price: 1.25, Change: +0.11, Percent Change: +9.56
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