.FDA Approves Bausch + Lomb, Novaliq Dry Eye Disease Drug
BIOMARKER
1. The FDA has approved Bausch + Lomb and Novaliq's Miebo ophthalmic solution to treat dry eye disease.
2. Miebo is administered as a single drop four times a day and targets tear evaporation.
3. The drug's active ingredient, perfluorohexyloctane, forms a protective layer over the tear film.
4. Clinical studies showed that Miebo significantly improved eye dryness and ocular surface integrity.
5. Symptom relief was observed as early as day 15 and lasted for the entire 57-day duration.
6. Miebo is expected to be available in the US market in the second half of 2023.
7. No boxed warning is included on Miebo's label, but patients are cautioned about the risk of blurred vision.
8. Bausch + Lomb licensed Miebo from Novaliq, with milestones and royalties tied to net sales.
9. Competitors in the dry eye disease space include Aldeyra's reproxalap and Palatin Technologies' PL9643.
10. Aldeyra's reproxalap has shown potential benefits in ocular dryness and tear production, with a decision expected in November 2023, while Palatin Technologies presented positive early Phase III data for PL9643.