REC 0/0559 Eye Drops for Treatment of Moderate and Severe Neurotrophic Keratitis in Adult Patients

Inclusion Criteria:

1. Have read, understood, and signed the informed consent form (ICF).

2. Be a male or female aged ≥18 years at the time of ICF signature.

3. Have stage 2 moderate (PED) or stage 3 severe (corneal ulcer) NK involving only 1eye (study eye) and of at least 2 weeks duration. Patients with Stage 1 NK in thefellow eye can be enrolled. for the study eye

4. Have no objective clinical evidence of improvement in the PED or corneal ulcerationwithin the 2 weeks before the screening visit despite use of conventionalnon-surgical treatment (eg, nonpreserved ocular lubricants, nonpreserved topicalantibiotics, oral doxycycline, patching, serum tears, and/or therapeutic contactlenses) as determined by the investigator's or referring physician's medical record.

5. Have decreased corneal sensitivity (≤ 4 cm using the Cochet-Bonnet aesthesiometer)within the area of the PED or corneal ulcer and outside of the area of the defect inat least one corneal quadrant.

6. Have a BCDVA score ≤ 75 ETDRS letters in the study eye, due to NK.

Exclusion Criteria:

1. Have participated in any clinical trial with an investigational drug/device within 2months before the Screening Visit and throughout the study duration.

2. Have a known hypersensitivity to one of the components of the study drug orprocedural medications (eg, fluorescein), including to a compound chemically relatedto MT8

3. Have a presence or history of any ocular or systemic disorder or condition thatmight hinder the efficacy of the study treatment or its evaluation, could possiblyinterfere with the interpretation of study results, or could be judged by theinvestigator to be incompatible with the study visit schedule or conduct (eg,progressive or degenerative corneal or retinal conditions, lagophthalmos, uveitis,optic neuritis, poorly controlled diabetes, autoimmune disease, systemic infection,neoplastic diseases), or that may compromise the safety of the patient.

4. Have a significant history of alcohol abuse or drug/solvent abuse

5. Be unwilling to comply with any study assessments or procedures.

6. Be a woman who is pregnant, nursing or planning a pregnancy.

7. Be a woman of childbearing potential not using a highly effective method of birthcontrol.

8. Be a male patient who is not permanently sterile and who is not willing to usecondoms during the study and for 4 weeks after the end of study treatment. For the study eye:

9. Have any active ocular infection (bacterial, viral, fungal or protozoal) or activeinflammation not related to NK in the study eye.

10. Have any other ocular disease requiring topical ocular treatment in the study eyeduring the course of the study treatment period, except for glaucoma if treated bypreservative-free eye drop (single-agent treatment, once daily, stable regimen 4weeks before screening and during the study),

11. Receive topical ophthalmological treatments other than the study drug provided bythe study Sponsor and the treatments allowed by the study protocol (eg,preservative-free artificial tears; preservative-free eye drop (single-agenttreatment, once daily, stable regimen 4 weeks before screening and during the study)for glaucoma; topical antibiotics; other than tetracycline).

12. Have severe blepharitis and/or severe meibomian gland disease in the study eye.

13. Have severe vision loss in the study eye with no potential for visual improvement inthe opinion of the investigator as a result of the study treatment.

14. Have evidence of corneal ulceration/melting involving the posterior third of thecorneal stroma, or perforation in the study eye.

15. Have a history of any ocular surgery (including laser or refractive surgicalprocedures) within 3 months before the Screening Visit in the study eye. Anexception to the preceding statement will be allowed if the ocular surgery isconsidered to be the cause of the Stage 2 or 3 NK.

16. Have a history of corneal transplantation in the study eye, except if performed totreat NK and at least 6 months prior screening.

17. Have had prior surgical procedures for the treatment of NK (eg, tarsorrhaphy,conjunctival flap, etc.) except AMT, if at least 2 wks after the membrane hasdisappeared within the area of the PED or corneal ulcer (and at least 6 weeks afterthe procedure) in the study eye.

18. Use therapeutic contact lenses or wear contact lenses for refractive correctionduring the study treatment periods in the eye(s) with NK.

19. Have an anticipated need for punctal occlusion during the study treatment period.Patients with punctal occlusion or punctal plugs inserted before the study areeligible for enrolment provided that the punctal occlusion is maintained during thestudy.

20. Have an uncontrolled glaucoma at the Screening Visit. (Patients suffering fromglaucoma requiring ophthalmic drops for topical treatment at the Screening Visit orduring the study are not eligible, except if the ophthalmic drops is apreservative-free treatment administered maximum once daily as a single-agenttreatment and at a stable regimen 4 weeks before screening and at the same doseduring the study. Patients treated with oral intraocular pressure-lowering drugs atthe Screening Visit and during the study may be enrolled if their glaucoma status isassessed as stable and controlled. For the fellow eye

21. Have Stage 2 or 3 NK or perforation. For any eye:

22. Have a history of ocular cancer.

23. Have had prior treatment with Oxervate™