We Await the Fate of a New Presbyopia Drop

HOT TOPIC

NDA Submitted for Aceclidine-Based Presbyopia Drop

Lenz Therapeutics has submitted a New Drug Application (NDA) with the FDA for LNZ100, an aceclidine-based ophthalmic solution to treat presbyopia.

LNZ100 is a preservative-free, single-use, once-daily eye drop that has shown significant promise in improving near vision in patients with presbyopia. The NDA submission is supported by positive data from the pivotal phase 3 CLARITY study, which demonstrated that LNZ100 achieved all primary and secondary near-vision improvement endpoints. Specifically, LNZ100 showed a statistically significant 3-line or more remarkable improvement in best-corrected distance visual acuity at near, without losing 1 line or more in distance visual acuity. This same study also showed that LNZ100 was well-tolerated, with no treatment-related severe adverse events observed over more than 30,000 treatment days.

The FDA has a 60-day filing review period to determine whether the NDA submission is complete and acceptable for review. If approved, LNZ100 would become the first aceclidine-based eye drop to improve near vision in patients with presbyopia, therefore offering a new therapeutic option for this condition.

My Two Cents

This submission marks a significant milestone for Lenz Therapeutics, and its team is to be commended! Upon doing more research on the phase 3 study, I was blown away by the results. It was reported that 71% of research participants achieved 3 lines or more remarkable near vision improvement at 3 hours, while 40% achieved 3 lines or more remarkable improvement at 10 hours. It looks like it could be longer than that in the real world, because 10 hours is when the study ended! Additionally, 75% of the patients surveyed after the study said they would want to continue to use the drop. Aceclidine is pupil-selective with a unique mechanism of action, which, if I’m reading it right, could theoretically eliminate the concern for a retinal detachment. Anyone is free to correct me if I’m wrong about that!

OUTSIDE THE LANE

Needle-Free Treatment for Anaphylaxis Approved

The FDA has approved the nasal spray Neffy (ARS Pharmaceuticals) as the first needle-free emergency treatment for anaphylaxis, marking a significant advancement in the treatment of life-threatening allergic reactions and offering an alternative to traditional epinephrine autoinjectors, such as EpiPen and Auvi-Q (Kaleo).

Neffy is a single-dose nasal spray administered into one nostril and is approved for use in adults and children weighing at least 66 pounds. The approval is based on four different studies involving 175 healthy adults without anaphylaxis, which measured the epinephrine concentrations in the blood following the administration of Neffy compared with approved epinephrine injection products.

The FDA’s decision to approve Neffy comes after initially declining approval last year and requesting additional testing despite the recommendation from its independent experts. The availability of a needle-free option is expected to reduce barriers to the rapid treatment necessary in most anaphylaxic situations. Kelly Stone, an associate director at the FDA’s Center for Drug Evaluation and Research, highlights that the nasal spray could be especially beneficial for children; the approval of Neffy is also seen as a significant step forward in providing more accessible and less intimidating treatment for anaphylaxis.

My Two Cents

The term “game-changer” is thrown around quite often in health care. This is one of those situations where it’s evident to anyone that this new treatment modality is, in fact, a game-changer. I’m curious if we can now stock this nasal spray in our offices for emergencies as opposed to the EpiPen, which many of our insurance companies/optometry boards require us to use.

CAN YOU RELATE

Lenz Therapeutics might allow us to hit the “reset” button on the pharmacologic treatment of presbyopia after the less-than-stellar uptake of Vuity (AbbVie) by the eye care field. I had tremendous success with Vuity, and multiple patients show up each week for their annual exam requesting refills on their scripts. Unfortunately, it seems to be getting more and more difficult for them to find the drop.

I spoke to doctors at various meetings about Vuity and my success in clinic with it. Many of my colleagues had highly valid concerns about the drop, and to me, it boiled down to two significant concerns: 1) causing a retinal detachment and 2) the relatively short period that it seemed to work in some patients (many reported benefits lasting only 3 to 4 hours). I can’t speak to whether Vuity caused any detachments, because I honestly don’t know, but that 3- to 4-hour window of effectivity was a factor in why many of my patients did not continue with the drop.

Looking at Lenz’s phase 3 data, it seems its new drop will provide for a substantially longer duration, and because it doesn’t have the effects on the ciliary body that pilocarpine does, it is expected that there would be less vitreous pull, thus resulting in less risk of retinal detachments. My research also shows that aceclidine is more selective for the pupil’s sphincter, which could result in loss of the brow aches that bothered some patients with pilocarpine.

I’m incredibly excited to see how this drop works if/when it gets approved by the FDA!