Published in Pipeline

LumiThera reports 24-month data from LIGHTSITE III trial for dry AMD

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4 min read

LumiThera, Inc. released data from its 24-month LIGHTSITE III clinical trial assessing the use of the Valeda Light Delivery System to treat patients diagnosed with dry age-related macular degeneration (AMD).

Tell me about this delivery system.

The Valeda Light Delivery System (LDS) is a multi-wavelength and non-invasive treatment that was the first to be CE-approved in the European Union for dry AMD using photobiomodulation (PBM). It is currently authorized for investigational use only in the United States.

The system uses a light-emitting diode system with three wavelengths (590 nm, 660 nm, and 850 nm) to carry a non-coherent, eye-safe column of light to deliver treatment to the eye via either an open or closed eyelid.

Watch Glance President Jackie Garlich, OD, FAAO, speak with LumiThera President and CEO Clark Tedford on the delivery system.

How long does treatment take?

Each treatment is expected to take > 5 minutes, with no need for pupil dilation. Patients are meant to receive treatment nine times across 3 to 4 weeks in order for the system to provide extended benefits.

What happened in the first two LIGHTSITE trials?

LIGHTSITE I (NCT02725762) and LIGHTSITE II (NCT03878420) assessed the use of PBM as treatment for dry AMD. Both studies demonstrated sustained improvements in visual benefits and concluded PBM could be considered a therapeutic treatment option for dry AMD.

Now talk about this trial.

The prospective, double-masked, randomized, multicenter trial enrolled 100 participants with early to intermediate dry AMD across 10 retinal centers in the United States. Each patient received treatment every 4 months, with the last being administered at 21 months and the final follow-up visit at 24 months.

Best-corrected visual acuity (BCVA) was the trial’s primary efficacy endpoint. Analysis was conducted on 91 eyes within the PBM-treated group and 54 eyes in the sham-treatment group.

Watch below to hear Tedford discuss the trial.

Initial findings?

Eighty percent of participants (80) completed the trial. A sustained and statistically significant improvement was initially observed in the BCVA at Month 13 in the PBM treatment group (compared to the sham treatment group; P = 0.02) as well as in the visual acuity at Month 21.

And now?

A mean increase in ETDRS letters score  >5.0 letters from baseline was reported at both the 13- and 21-month timepoints in the PBM-treated subjects BCVA (P<0.0001).

At 24 months, the baseline improvement in BCVA for the PBM treatment group was significantly larger than the sham group (5.9 vs 1.0 letters [P = 0.015]). Further, an estimated 58% of PBM-treated eyes achieved a >5.0 letter gain with a mean of 8.5 + 0.5 letter gain.

What else?

Optical coherence tomography (OCT) was used to conduct a retinal morphology analysis; 24-month data found that 5.7% of PBM-treated eyes (88 total) had progressed to a new geographic atrophy (GA), while 21.6% of sham-treated eyes (51 total) developed new GA.

Take home?

Investigators reported that the use of PBM as treatment resulted in a statistically significant slowing of disease progression in patients with early to intermediate dry AMD, including those who might suffer from new GA lesions.

Below, Tedford speaks on a tentative timeline for an FDA approval in the United States.