Orasis Pharmaceuticals is an emerging ophthalmic pharmaceutical company developing an optimized formulation of a presbyopia correcting prescription eye drop, CSF-1. From the beginning, having the patient in mind, we realized that in order to have a successful alternative to reading glasses, we needed an optimal balance of efficacy safety and comfort. Identifying the minimal effective concentration of pilocarpine 0.4% was critical as we understood the historical challenges with higher concentration miotics (used primarily to treat glaucoma). In addition, we optimized our preservative-free formulation at a near-neutral pH along with a multi-faceted vehicle to assist with comfort.
Orasis has completed Phase 3 clinical trials in the US, filed with the FDA, and received a PDUFA date of October 22, 2023. Consistent with our Phase 2b results, we were pleased that our Phase 3 studies (NEAR-1 & NEAR-2) met their primary and key secondary endpoints on Day 8, achieving statistically significant 3-line or more gain in distance-corrected near visual acuity with no loss of 1-line or more in distance visual acuity. Pooled across the two studies, CSF-1 achieved statistical significance at all efficacy time points measured – from 20 minutes out to 8 hours on Day 15.
We’ve also analyzed additional endpoints such as 2-line improvement, which could be appropriate for early to moderate presbyopes, along with functional vision at 20/40 near (J3). CSF-1 also demonstrated favorable comfort scores (using formal comfort assessment) and essentially no changes in eye redness.
Our goal at Ophthalmology Futures is to share insights into the novel formulation of CSF-1, share newly presented data from our pooled Phase 3 trials, and identify potential partner(s) as Orasis prepares to enter the US market, then subsequent global markets, to build a novel, new category to pharmaceutically treat presbyopia. This temporary treatment could serve as a bridge until patients are ready for permanent/advanced presbyopic solutions. With over 120 million presbyopes in the US, and over 2 billion globally, we know patients are waiting. CSF-1 will provide an excellent addition to what eye care providers are recommending today, giving early to moderate presbyopes an alternative when they want a break from readers until they choose a more permanent treatment option.