Ocular Therapeutix Eyes Q4 AXPAXLI NDA After FDA Alignment

Ocular Therapeutix Eyes Q4 AXPAXLI NDA After FDA Alignment

Key Points Ocular Therapeutix says it remains on track to file an NDA for AXPAXLI in wet age-related macular degeneration in Q4 , after reaching alignment with the FDA on the planned submission package. The company says the FDA agreed AXPAXLI can pursue the 505(b)(2) pathway and that Ocular believes its SOL-1 trial and safety data support a single-trial approval approach, though final review and approval decisions still rest with the agency. Management described the upcoming pre-NDA meeting as largely logistical and said Ocular is financially prepared for launch, with existing commercial infrastructure from Dextenza and cash expected to fund operations into 2028 .

Ocular Therapeutix NASDAQ: OCUL said it remains on track to submit a New Drug Application for AXPAXLI in wet age-related macular degeneration in the fourth quarter, after what Executive Chairman, President and CEO Dr. Pravin Dugel described as alignment with the U.S. Food and Drug Administration on the planned filing package. Speaking during a fireside chat at the H.C. Wainwright 6th Annual Ophthalmology Virtual Conference, Dugel said the company’s recent FDA interactions were the result of more than two years of work and not a sudden change in regulatory strategy.

FDA Submission Pathway Dugel distinguished between the FDA accepting a proposed package for submission and making an approval decision, which remains subject to agency review. He said the company believes it has met the evidentiary standards for a single-trial approval pathway, including study masking, statistical powering, a p-value threshold and safety exposure requirements. According to Dugel, SOL-1 was conducted under a Special Protocol Assessment, or SPA, and he said the study met pre-specified standards for masking and powering. He also said the trial achieved a p-value below 0.0006, compared with the standard he cited of less than 0.001, and that Ocular can present at least 300 patients exposed to the drug by including patients from SOL-R for safety purposes.

Dugel said the FDA’s written minutes stated that the company has “very compelling data” and that the agency would accept the company’s package as a complete submission. He repeatedly emphasized, however, that the FDA review team will still conduct its review after submission.

Pre-NDA Meeting Described as Operational Ocular Therapeutix expects a pre-NDA meeting in the third quarter. Dugel characterized that meeting as operational rather than substantive, saying it would address filing logistics such as table formatting, locations, font sizes and hyperlinks. He said poor organization of those materials could cause delays of two to four weeks if reviewers require corrections, but he said the meeting would not involve content decisions. The company continues to expect a complete NDA submission in the fourth quarter. Dugel declined to guide on whether the application might receive standard or priority review, whether an advisory committee would be convened, or the approximate review timeline, saying those decisions are up to the FDA.

505(b)(2) Pathway and Manufacturing Dugel said the FDA has formally agreed that Ocular will use the 505(b)(2) pathway for AXPAXLI. He said that pathway could save time because the FDA has already approved the two components of the product: the tyrosine kinase inhibitor and the hydrogel. He also pointed to Ocular’s existing commercial product Dextenza, saying it uses the same hydrogel as AXPAXLI. Dugel said Dextenza has undergone multiple FDA revi...