Alcon to Acquire LumiThera, Maker of Photobiomodulation Device for the Treatment of Dry AMD

In a move to bolster is vitreoretinal surgery portfolio, Alcon announced its intention to acquire LumiThera and its photobiomodulation (PBM) device for the treatment of dry early and intermediate dry AMD.

Financial terms of the deal were not disclosed. 

According to Alcon, LumiThera’s PBM is the only device that has demonstrated meaningful vision improvement compared to baseline for people living with early to intermediate dry AMD.[2]

The device, branded as the Valeda Light Delivery System, received FDA de novo market authorization in November 2024 and CE Mark in November 2018. PBM is currently available in Europe, Latin America, Singapore, the U.K. and the U.S.

“Dry AMD is an area of significant unmet need, and PBM is an efficacious, noninvasive light therapy that can provide visual improvement for patients with early and intermediate disease," Sean Clark, Vice President and General Manager, Global Surgical Franchise, Alcon, said in a company news release. "With Alcon’s global commercial and clinical expertise, we have the potential to make this therapy more broadly available to eye care professionals and their patients, while continuing to strengthen its body of clinical evidence.”

PBM uses low-level light to stimulate mitochondrial energy production, promoting retinal cellular health. It uses three specific, science-backed wavelengths—delivering non-phototoxic light therapy (not laser therapy).[7,8] The noninvasive treatments are administered while the patient is sitting comfortably in a clinic setting.

Data from the LIGHTSITE I, II, and III clinical trials showed that PBM treatments provide visual acuity improvement with no treatment-related serious adverse events reported.[2] The pivotal LIGHTSITE III study was conducted at 10 sites across the U.S. and evaluated 2 years of PBM treatment versus a control light therapy. The results showed:

• Patients with PBM-treated eyes on average experienced visual acuity improvement—gaining one line of visual acuity (ETDRS) from Baseline at Months 13, 21 and maintained at Month 249
• About 88% of patients in the PBM group maintained or gained vision versus Baseline at Month 249
• Nearly two-thirds of patients (64%) with PBM-treated eyes experienced visual acuity improvement—gaining at least one line of visual acuity (ETDRS) from Baseline at Month 249
• More than 97% of patients reported no pain or discomfort
• More than 80% of patients stayed on therapy for two years—the recommended course of treatment

"We are thrilled that Alcon agrees in the potential that this device has to change the lives of millions living with dry AMD, and we are confident that Alcon has the capabilities to broadly commercialize it," said Clark Tedford, PhD, President and CEO of LumiThera.

The PBM technology is intended to provide improved visual acuity in patients with best-corrected visual acuity of 20/32 through 20/70 and who have dry age-related macular degeneration (AMD) characterized by:

• The presence of at least 3 medium drusen (> 63 μm and = 125 μm in diameter), or large drusen (> 125 μm in diameter), or non-central geographic atrophy, AND
• The absence of neovascular maculopathy or central-involving geographic atrophy

The transaction does not include the acquisition of AdaptDx and Nova/Diopsys diagnostic devices, which will be separated and spun-off to LumiThera’s shareholders prior to Alcon’s acquisition and will continue to be marketed and sold by the LumiThera spin-off. Alcon and LumiThera anticipate the acquisition to be completed in the third quarter of 2025, subject to customary closing conditions and a LumiThera shareholder vote.

References

1. U.S. Food and Drug Administration. De Novo classification request for Valeda Light Delivery System (DEN230083). Accessed June 2025 at https://www.accessdata.fda.gov/cdrh_docs/pdf23/DEN230083.pdf.
2. LumiThera, Inc. A double-masked, randomized, sham-controlled, parallel group, multi-center study to assess the safety and efficacy of photobiomodulation (PBM) in subjects with dry age-related macular degeneration (AMD) (LIGHTSITE III). Clinical Study Report CSP005.
3. Wong WL, Su X, Li X, et al. Global prevalence of age-related macular degeneration and disease burden projection for 2020 and 2040: a systematic review and meta-analysis. The Lancet Global Health. 2014;2(2):e106–e116. DOI: 10.1016/S2214-109X(13)70145-170145-1.
4. Centers for Disease Control and Prevention. About Common Eye Disorders and Diseases. Accessed in June 2025 at www.cdc.gov/vision-health/about-eye-disorders/index.html.
5. Mitchell P, Liew G, Gopinath B, Wong TY. Age-related macular degeneration. The Lancet. 2018;392(10153):1147–1159. DOI: 10.1016/S0140-6736(18)31550-2.
6. Eells JT. Mitochondrial dysfunction in the aging retina. Biology (Basel). 2019;8(2):31. DOI: 10.3390/biology8020031.
7. Wong-Riley MTT, Liang HL, Eells JT, Chance B. Photobiomodulation directly benefits primary neurons functionally inactivated by toxins: Role of cytochrome c oxidase. J Biol Chem. 2005;280(6):4761–4771. DOI: 10.1074/jbc.M409650200.
8. Ball KA, Castello PR, Poyton RO. Low intensity light stimulates nitrite-dependent nitric oxide synthesis but not oxygen consumption by cytochrome c oxidase: Implications for phototherapy. Biochim Biophys Acta. 2011;1807(7):964–970. DOI: 10.1016/j.bbabio.2011.04.003.
9. Valeda® Light Delivery System User Manual (LBL-0001-01 REV C).