Ocular Therapeutix (OCUL) Hits 4-Year High on Axpaxli NDA Application

We recently published 10 Stocks Standing Tall Amid Market Fall; 6 Hit Record Highs. Ocular Therapeutix, Inc. (NASDAQ:OCUL) is one of the best performers on Monday.

Ocular Therapeutix surged to a new four-year high on Monday after rallying for four consecutive days, with investor sentiment bolstered by announcements that it would officially submit a new drug application (NDA) for Axpaxli for the treatment of wet age-related macular degeneration (AMD).

At intra-day trading, the stock soared to its highest price of $16.44 before trimming a few cents to end the day just up by 28.06 percent at $16.11 apiece.

A medical technician holding the instruments in her hands

In a statement on Monday, Ocular Therapeutix, Inc. (NASDAQ:OCUL) said that it would submit the NDA shortly, assuming it generates positive results from the one-year data of its SOL-1 clinical trial to test the efficacy of Axpaxli.

Historically, the FDA requires two adequate and well-controlled clinical trials to demonstrate the safety and efficacy of ophthalmic product candidates, particularly for larger indications of use such as wet AMD.

However, recent statements indicate that the agency would now move to requiring just a single registration trial for approval, as long as the study was adequately powered and controlled.

Ocular Therapeutix, Inc. (NASDAQ:OCUL) said that it expects additional data from the second year of the SOL-1 clinical trial—to be called SOL-R and SOL-X—to help clinicians and payors appreciate the anticipated benefits of Axpaxli’s efficacy, safety, and durability.

“The company will engage further with the FDA regarding next steps on the regulatory pathway for AXPAXLI and will provide updates as appropriate,” it said.