Needham initiated coverage on Ocular Therapeutix Inc OCUL, noting the company’s lead asset, Axpaxli, an investigational axitinib-based intravitreal implant for wet age-related macular degeneration (wet AMD).
Axpaxli is the company’s key value driver and is under evaluation in two phase 3 trials. If positive, these trials could support approval with a product label that enables maintenance treatment with Q6M (every 6 months)-Q12M (every 12 months) dosing, which would represent a significant improvement over current treatment options that offer up to Q2M (every two months)-Q4M (every 4 months) dosing.
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Ocular Therapeutix has completed randomization in the first wet AMD trial, SOL-1. The company expects topline results for SOL-1 to be available in the fourth quarter of 2025.
The company has enrolled 311 subjects in SOL-R, Ocular’s second registrational trial of Axpaxli in wet AMD. The company also plans to seek FDA feedback in the first half of 2025 on clinical trial design for Axpaxli in non-proliferative diabetic retinopathy (NPDR).
The analyst Serge Belanger has initiated with a Buy rating and a price target of $15.
Needham writes that intravitreally injected anti-VEGFs make up the ~$15 billion retinal disease market.
The analyst expects Axpaxli to play a role as a second-line treatment in the ~40% of 1.65 million wet AMD patients treated with anti-VEGFs who fail to adequately respond to anti-VEGFs and/or are dissatisfied with the high number of required IVT injections. Needham expects peak sales of around $1.5 billion based on a 15-20% share of this second-line AMD patient population.
“We believe Axpaxli’s product profile and unique pivotal ph 3 program offer substantial advantageous differentiation over other products in development seeking to provide long-term treatment duration,” Needham writes.
Ocular Therapeutix reported a fourth-quarter loss of 29 cents per share, compared to a consensus of 24 cents, with sales of $17.1 million.
The company expects its cash balance of $392.1 million to fund operations into 2028 without raising additional capital.
Price Action: OCUL stock is up 10.10% at $8.42 at the last check on Tuesday.
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